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The Director/Senior Director, Product Safety and Pharmacovigilance is a highly scientific and mid-level leadership role that requires medical and safety expertise as the Product Safety and Pharmacovigilance representative on the product clinical development team. In addition, he/she manages and conducts ongoing safety surveillance for assigned products. Also, oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary. Additionally, he/she collaborates with cross-functional groups and other regional safety counterparts to update them on medical assessment, safety signal detection, and risk management practices in the US and international markets. The candidate will have broad knowledge and perspective of drug safety in pharmaceutical/biotech industry and clear understanding of safety reporting requirements and experience in global regulatory environment and processes. MAJOR RESPONSIBILITIES • Provide medical and safety expertise as the Medical Safety and Pharmacovigilance representative on the product clinical development team., • Lead the preparation and delivery of high quality, consistent and compliant safety information for regulatory submission documents (including IND and NDA)., • Lead/develop strategies for safety-related regulatory activities and support interpretation and authoring of safety sections of documents including Investigators Brochures, clinical trial protocols, informed consent forms, safety management plans, clinical study reports, integrated safety summary and summary of clinical safety., • Manages and conducts ongoing safety surveillance on assigned products. Oversees the preparation of NDA safety updates, IND safety reports, investigator communications, product labeling/package inserts and other periodic safety reports as necessary., • Co-organize, prepare and conduct safety management team meetings for assigned products and responsible for safety surveillance, signal detection and risk management., • Coordinates the new development or maintenance of internal SOPs/WIs to ensure the uniform and timely processing of adverse event reports. Interfaces with internal and external collaborators to develop programs and processes to meet regulatory reporting requirements., • Applies general safety signal management methodologies and product specific signaling strategies to monitor for emerging issues related to assigned products., • Ensure that the safety profiles of assigned HMP products are accurately and consistently represented in relevant labeling documents, identify and lead updates as required., • Perform medical review of individual case safety reports (ICSRs) for assigned products., • Collaborate with cross-functional groups and other regional counterparts to update them on medical assessment, signal detection and safety risk management practices in the US and international markets, • Identify opportunities and manage continuous improvement initiatives as related to medical assessment of pharmacovigilance data., • Assist in the creation, review and implementation of SOPs, Work Instructions, guidelines, documents and other tools pertaining to safety assessment and risk minimization. QUALIFICATIONS • Physician (MD, DO, or equivalent) or PharmD, or PhD in Nursing/Pharmacy with minimum 6-10 years related experience in clinical safety and pharmacovigilance., • Experience in the oncology therapeutic area is preferred., • Demonstrated knowledge of principles of drug development, pharmacology, clinical trial methodology and design, medical monitoring of trials, assessment of drug risks and benefits, and global safety regulations are highly preferred., • Experienced in global regulatory environment and processes (US, UK, EU, AU, JP), and the ability to integrate safety medical knowledge with regulatory and commercial input., • Ability to critically evaluate safety data from multiple sources (clinical trials, animal studies, post-market environment, literature, etc), assess clinical importance, benefit risk and potential strategic impact of the data and present the findings clearly in both written and oral communications., • Experienced in writing/review of aggregate safety documents (DSUR, PSUR, and PBRER etc.) and risk management plans., • Thorough understanding of US and European pharmacovigilance regulations, GCP and ICH guidelines., • Demonstrated knowledge of biostatistics and epidemiology are preferred., • Good ability to interpret complex clinical data and experimental results., • Working knowledge of validated drug safety database (preferably ARGUS) and MedDRA., • Ability to influence, negotiate and communicate with both internal and external stakeholders., • Excellent English (writing and speaking) and excellent mastery of English medical terminology.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs., • May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)., • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications Qualifications • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a complex clinical research program independently., • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence., • Ability to interact externally and internally to support a global scientific and business strategy., • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills., • Ability to exercise judgment and address complex problems and create solutions for one or more projects. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Leads the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in and may lead cross-functional teams to generate, deliver, and disseminate high-quality clinical data supporting overall product scientific and business strategy. Responsibilities • Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for leading clinical study teams, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for ensuring agreed-upon study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical and/or Scientific Directors and of Clinical Scientists working on the same or related programs., • May serve on or chair Clinical Strategy Team(s), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to Asset Development Teams (ADTs) and ADT Leadership Boards (ALBs)., • Serves as an in-house clinical expert for one or more molecules and diseases in the therapeutic area, coordinating and leading appropriate scientific and medical activities with internal stakeholders as they relate to ongoing projects. May participate in or lead clinical development contributions to due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • Acts as clinical lead and actively solicits opinion leader interactions related to the disease area(s); partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent AbbVie at key external meetings., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 5 years (7 years preferred) of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a complex clinical research program independently., • Proven leadership skills and ability to bring out the best in others on a cross-functional global team. Must be able to lead through influence., • Ability to interact externally and internally to support a global scientific and business strategy., • Extensive knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials, and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills., • Ability to exercise judgment and address complex problems and create solutions for one or more projects. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job Description Assistant/Associate/Full Professor Large Animal Surgery – Northeast #9256 Our client is a College of Veterinary Medicine located in the Northeast USA and is looking for a self-directed, innovative, and motivated candidate for a full-time, clinical-track or tenure-track faculty position in Large Animal Surgery (predominantly equine surgery). The position may be filled as Assistant, Associate, or Full Professor. Successful candidates will be engaged in the College’s educational, research, and service activities. Primary responsibilities will include clinical and didactic teaching in the equine medicine course and equine laboratories. No clinical duty is expected, but there may be opportunities with affiliate practices. Successful candidates are expected to promote the College’s overall mission of enhancing veterinary medical education through a commitment to teaching, academic excellence, and service to a variety of stakeholders. Active engagement in curriculum development, identification or creation of innovative learning resources, and committee service participation (such as admissions, curriculum, research, etc.) is expected of both clinical and tenure-track faculty. All tenure-track faculty contribute to the overall research and scholarly goals of the College of Veterinary Medicine and are expected to develop independent or collaborative research in the field of Large Animal Surgery within and outside of the College, which may include working with College partners/affiliate veterinary hospitals. Qualifications: The successful candidate will have a DVM or equivalent degree and expertise in large animal surgery/equine surgery. Specialty board certification/eligibility by the American College of Veterinary Surgeons (ACVS LA) or equivalent is preferred. Advanced training in large animal/equine surgery and or large animal surgery/equine surgery research with an MS or PhD is preferred. The ideal candidate should have working knowledge of curricular design and implementation. The candidate will be the course director of the large animal surgery/equine surgery course. Contact us today if you believe you are the ideal candidate for this job opportunity. Company DescriptionThe VET Recruiter has a simple mission - helping our clients and candidates achieve their goals by building long-term relationships based on trust, professionalism, and results. We've placed hundreds of professionals including executives, managers, veterinarians, sales reps, and more in areas including professional services, research and development, pharmacovigilance, regulatory affairs, marketing, sales, etc. with large industry leaders, midsize and 'start up' companies, non profits, as well as in veterinary hospitals. We have helped build start up organizations from the ground floor. We specialize in the Animal Health and Nutrition, Veterinary, Agribusiness, Life Sciences & Pet Products industries and are industry insiders. By being on the front lines talking with hundreds of Animal Health, Pet Industry and Veterinary Professionals every week, we have unique insight on what's going on in the market before news hits the street. We know who the top players are, both employers and candidates, and are the firm that they call FIRST when they need a search partner on whom they can depend. With our singular focus on Animal Health, Veterinary & Pet Products, there is no firm better connected in this market. Whether you need to hire one person or a team of people, or are looking to make your next career move, no one can help you achieve your goals faster and more effectively than The VET Recruiter.The VET Recruiter has a simple mission - helping our clients and candidates achieve their goals by building long-term relationships based on trust, professionalism, and results. We've placed hundreds of professionals including executives, managers, veterinarians, sales reps, and more in areas including professional services, research and development, pharmacovigilance, regulatory affairs, marketing, sales, etc. with large industry leaders, midsize and 'start up' companies, non profits, as well as in veterinary hospitals. We have helped build start up organizations from the ground floor.\r\n\r\nWe specialize in the Animal Health and Nutrition, Veterinary, Agribusiness, Life Sciences & Pet Products industries and are industry insiders. By being on the front lines talking with hundreds of Animal Health, Pet Industry and Veterinary Professionals every week, we have unique insight on what's going on in the market before news hits the street. We know who the top players are, both employers and candidates, and are the firm that they call FIRST when they need a search partner on whom they can depend.\r\n\r\nWith our singular focus on Animal Health, Veterinary & Pet Products, there is no firm better connected in this market. Whether you need to hire one person or a team of people, or are looking to make your next career move, no one can help you achieve your goals faster and more effectively than The VET Recruiter.

Job DescriptionCompany Description About AbbVie AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. Job Description Purpose: Oversees the direction, planning, execution, and interpretation of clinical trials or research activities of one or more clinical development programs. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Responsibilities: • Manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations, and emerging issues. Oversees project-related education of investigators, study site personnel, and AbbVie study staff., • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity, and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the molecule. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned., • Responsible for design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents., • May oversee the work of Medical Directors and/or Scientific Directors, and of Clinical Scientists working on the same or related programs., • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific and medical activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies., • May serve on or chair a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches. In the role of CST Chair, responsibilities may include supervision of matrix team members and serving as Clinical Research representative to lend clinical development and medical expertise to an Asset Development Team (ADT), ADT Leadership Board (ALB)., • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate., • Stays abreast of professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area., • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions., • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.Qualifications, • Medical Doctor (M.D.), Doctor of Osteopathy (D.O.) or non-US equivalent of M.D. degree with relevant therapeutic specialty in an academic or hospital environment. Completion of a residency program strongly preferred. Completion of a subspecialty fellowship is desirable., • At least 2 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent., • Ability to run a clinical research program of moderate complexity with minimal supervision., • Ability to perform and bring out the best in others on a cross-functional global team., • Ability to interact externally and internally to support a global scientific and business strategy., • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols., • Must possess excellent oral and written English communication skills. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of thisposting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our long-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless anduntil paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

Job DescriptionCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Product Safety Team (PST) lead for late stage oncology products, under the direction of the Group Lead and TA Head will be actively and closely collaborating with the development medical lead, setting the strategy for the oncology programs. PST lead will be responsible to one or more products and will ensuring safety through the product lifecycle (e.g. surveillance, signal detection, validation and assessment, risks assessment and mitigations strategies, tox management, etc…) together with the other members of the safety team (safety scientists, safety architects, safety PM, and other cross functional colleagues). The PST lead will also closely collaborate with a PK and toxicology leads, regulatory and clinical development leads as well as medical affairs colleagues to help guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS. PST lead will be interpreting regulations related to pharmacovigilance supporting all patient safety activities, and will be leading the safety components of pre-NDA and NDA/sNDA submissions, regulatory responses, label and label updates, RMPs. Responsibilities: • Understanding and application of the pharmacology, chemistry and non-clinical toxicology to effectively conduct safety surveillance, • Responsible for safety surveillance for pharmaceutical / biological / drug –device combined products, • Lead and set the strategy for key pharmacovigilance documents, including but not limited to, medical safety assessments, regulatory responses and risk management plans, NDA/sNDA submission – safety component, • Apply current regulatory guidance as appropriate for safety surveillance and authorship of PV documents, • Analyze and interpret aggregate safety data and communicate these analysis and interpretation to cross-functional teams, executive leadership and externally, as needed, • Effectively write, review and provide input on technical documents independently, • Oversight and responsibility for leading the strategy for periodic reports (DSURs, PSURs, PADERs etc.), • Responsible for implementing risk management strategies for assigned products, • Proactively engaging, inspiring, coaching and mentoring team and colleagues, • Opportunities to co-author publications and participate in initiatives to continue developing and growing as a safety leader, • Strong team player, able to adapt and work in a fast pace environment, • Significant Work Activities -Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Qualifications, • MD / DO with 2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, not required, • 5 - 8 years of Pharmacovigilance (PST lead role equivalent) / Clinical Development experience in the pharmaceutical industry required, • Oncology experience strongly preferred, • Effectively analyze and guide analysis of clinical data and epidemiological information, • Effectively present recommendations / opinions in group environment both internally and externally, • Write, review and provide input on technical documents, • Work collaboratively and lead cross-functional teams, • Ability to lead cross-functional teams in a collaborative environment Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs. This job is eligible to participate in our long-term incentive programs Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html

We Are Teva We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together. ## Our Team, Your Impact The Associate Director, Operations Management provides strategic and operational leadership for vendor-supported Patient Services programs. This role is accountable for overseeing complex hub operations, ensuring vendor performance and compliance, and driving cross-functional execution against business priorities. The Associate Director serves as a key partner across Patient Services, Market Access, Compliance, Pharmacovigilance, Finance, Field Teams, and external vendors to proactively identify risks, strengthen operational readiness, and advance process improvements that enhance the patient and provider experience. This position also helps shape operational strategy, supports program evolution and launch readiness, and provides leadership, guidance, and coaching across the broader team. ## How You'll Spend Your Day All areas of responsibility listed below are essential to the satisfactory performance of this position by any incumbents with reasonable accommodation if necessary. Any non-essential functions are assumed to be included in other related duties or assignments. ⦁ Provide strategic oversight of hub vendor operations supporting Patient Services programs, ensuring alignment with enterprise priorities and program objectives. ⦁ Establish and maintain performance expectations for vendors, including service levels, quality standards, compliance requirements, and KPI deliverables. ⦁ Lead oversight of staffing models, workflows, productivity, and service delivery to ensure scalable, efficient, and patient-centered operations. ⦁ Analyze vendor reporting, KPIs, and operational trends to inform decision-making, identify performance gaps, and recommend corrective actions. ⦁ Proactively identify operational risks, process gaps, and emerging issues, and lead mitigation plans in partnership with internal and external stakeholders. ⦁ Partner with vendors to enhance dashboards and reporting transparency. ⦁ Serve as a senior escalation point for complex operational issues affecting patients, providers, vendors, or internal stakeholders, ensuring timely resolution and appropriate governance. ⦁ Drive timely resolution of issues through collaboration with vendors and internal partners. ⦁ Lead cross-functional collaboration with Market Access, Compliance, Pharmacovigilance, Field Teams, Finance, and Operations to align strategy, execution, and issue resolution. ⦁ Translate vendor performance, key risks, and operational recommendations into clear, actionable updates for senior leadership. ⦁ Oversee PARC submissions and related governance processes to support operational decision-making, business continuity, and compliance. ⦁ Provide oversight of invoicing, budget tracking, and financial reconciliation activities to support sound fiscal management and vendor accountability. ⦁ Lead continuous improvement initiatives that enhance operational efficiency, service quality, reporting transparency, and stakeholder experience. ⦁ Support operational readiness for program launches, enhancements, and strategic initiatives by ensuring processes, vendors, and stakeholders are prepared for successful execution. This position will be based out of Parsippany, NJ in a hybrid work environment, 2-3 days onsite, or flexible for a remote work environment for the right candidate ## Also Good to Have TRAVEL REQUIREMENTS ⦁ Approximately 30% domestic travel throughout the US, which may include weekend and overnight trips PHYSICAL REQUIREMENTS: Occasional: ⦁ Sitting for extended periods of time at workstation or mobile equipment. Visual Acuity: ⦁ Perform activities such as computer work, preparing and analyzing data, and extensive reading. WORKING ENVIRONMENT ⦁ May be required to wear personal protective equipment (PPE) as needed on site visits (i.e. safety glasses, hearing protection, gloves, etc.). ## Salary Range The annual starting salary for this position is between $164,960- $216,510 annually. Factors which may affect starting salary within this range and level of role may include geography/market, skills, education, experience and other qualifications of the successful candidate. ## How We'll Take Care of You We offer a competitive benefits package, including: Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan. Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, and holiday. Life and Disability Protection: Company paid Life and Disability insurance. * Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more. The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. ## Already Working @Teva? Make sure to apply through our internal career site on Twist-your one-stop shop for career development ## Teva's Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws. Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to AskHR@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address. Important notice to Employment Agencies - Please Read Carefully Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

POSITION SUMMARY: The Principal, Pharmacovigilance / Device Vigilance is a detail-oriented and proactive professional supporting the safety surveillance of In Vitro Diagnostic and Software-driven products across their lifecycle, including clinical studies and post-market activities. This role is responsible for the collection, assessment, reporting, and management of adverse events, product complaints, and safety data for both medicinal products and medical devices, ensuring compliance with global regulatory requirements. The position plays a critical role in ensuring compliance with global regulatory requirements (e.g., FDA, EU IVDR, Japan) and maintaining the highest standards of patient safety and product quality across both laboratory-developed tests and regulated IVD products, including software/algorithm-based components. PRIMARY RESPONSIBILITIES: Pharmacovigilance (Drug Safety) Perform case intake, triage, and processing of Individual Case Safety Reports (ICSRs) Process and evaluate adverse events associated with diagnostic use (e.g., clinical impact of false positives/negatives) Coordinate medical review and causality assessment of adverse events Coordinate timely submission of safety reports (e.g., MedWatch, EudraVigilance, CIOMS) Support aggregate reporting (PSUR/PBRER, DSUR, annual reports) Maintain and ensure compliance with global PV regulations (FDA, EMA, ICH, etc.) Contribute to signal detection and risk management activities Review, triage, and assess product complaints and adverse events related to genetic and diagnostic testing, including incorrect, delayed, or misinterpreted results Evaluate reportability of events under FDA (MDR), EU IVDR vigilance, Japan and other global regulations Prepare and submit Medical Device Reports (MDRs) and vigilance reports within regulatory timelines Collaborate with laboratory operations, bioinformatics, and software teams to investigate root cause (e.g., assay performance, variant interpretation, software defects) Support post-market surveillance activities, including trending, signal detection, and periodic safety reporting Assess safety events associated with software as part of a medical device system, including algorithm errors, data processing issues, and reporting inaccuracies Partner with engineering and data science teams to evaluate software-related complaints and implement corrective actions Contribute to risk management activities (e.g., hazard analysis, risk files, FMEA updates) for software and integrated diagnostic systems Ensure compliance with SOPs, GVP, and applicable quality systems (QMS) Partner with Clinical, Regulatory Affairs, Quality, and Medical Affairs teams Support audits and inspections (internal and external) Maintain accurate documentation in safety databases Assist in vendor oversight (e.g., CROs, safety service providers) Other duties as assigned Ability to provide support outside of standard business hours for expedited reporting requirements as needed QUALIFICATIONS: Bachelor’s degree in life science field (biology, microbiology, chemistry, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred. RAC preferred. Minimum of 12 years of direct applicable experience in pharmacovigilance and/or device vigilance Strong knowledge of global safety regulations (FDA, EMA, ICH, EU IVDR, Japan) Experience with safety databases (e.g., AEMS, Argus, ARISg, Veeva Safety) Familiarity with MedDRA coding and case processing workflows Knowledge of applicable standards, including ISO 13485 and ISO 14971 Advanced degree (PharmD, MD, MPH, MSc) Experience in diagnostics or combination products Prior audit/inspection experience RAC, PV certification, or similar credentials KNOWLEDGE, SKILLS, AND ABILITIES: Experience with global markets is highly desirable Strong analytical and clinical assessment skills Attention to detail and regulatory compliance mindset Ability to manage multiple priorities and deadlines Excellent written and verbal communication Cross-functional collaboration Demonstrated self-starter and highly motivated, energetic and enthusiastic. Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices, which includes analytical problem solving. Demonstrated organizational, planning, and program management skills, including action oriented, focused urgency and driving for results. Ability to be effective in complex projects with ambiguity and/or rapid change Excellent written and verbal communication skills including ability to communicate across cultures work with others in a team environment; effective interactions with technical and medical personnel. Computer literacy (PC, Microsoft Office and Google Workspace). The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $160,700 - $200,850 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit _. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: _ Please be advised that Natera will reach out to candidates with a @_ email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: • _, • _

• Candidates Must Reside Within the Houston, TX Area* Purpose and Scope Under limited supervision, the Account Manager- PE is responsible for achieving sales objectives in assigned territory through the development, maintenance, and enhancement of the business. These customers include Pediatric Endocrinologists, nurses, pharmacists, pharmacy and therapeutics groups, teaching institutions, private and federal hospitals and formulary committees. The Account Manager- PE is responsible for ensuring customer’s clinical conviction in the product and seeing the sale through to its conclusion by providing sufficient training and ongoing customer service. The Account Manager- PE will develop territory business plans and work with the sales management team to maximize the impact of sales and marketing plans and tactics. Essential Duties & Responsibilities • Create, maintain and increase sales within designated territory by influencing the prescribing habits of the targeted audience by calling on health care providers and health-related organizations within assigned territory., • Strategically identify and develop relationships with non-prescribing health care providers that influence decision making in accounts such C suite personnel, pharmacy personnel, injecting nurses, Medical Assistants, office managers and personnel, etc., • Sell in various sites of care within territory including clinics and health systems (all sites of care within health systems including but not limited to Specialty Pharmacies, In patient pharmacies, infusion centers, specialty clinics etc., • Conduct effective and compliant mixing and administration demonstrations to appropriate customers, • Demonstrate advanced business acumen, • Demonstrate thorough on-label knowledge of products by effectively communicating appropriate clinical, technical, therapeutic, disease state and product information to customers., • Complete routine reports and be compliant with industry, regulatory and company guidelines and prepare annual business plans and conduct quarterly analysis of the territory performance vs. plan., • Attend and represent the Company at internal company meetings and external trade shows, community events, etc, as appropriate., • Manage usage and inventory of promotional items to be given away to offices., • Abide by Administrative Expectations as defined by AMP SOPs: Submit expense reports regularly as outlined, enter sales calls in CRM system daily or as indicated by Regional Sales Director, enter company car mileage weekly, maintain company car as required by Fleet Maintenance., • Manage promotional budget effectively and in a compliant manner., • Partner with different departments in the Company as the business requires., • Abide by the Company’s email and communication SOPs., • Regular and punctual attendance is an essential function of the job. It is expected that our sales force is “in the field” calling on customers from 8:00am to 5:00pm each day., • Responsible for reporting Adverse Events and Technical Complaints to Tolmar Pharmacovigilance and Patient Safety (PSSP) that you learn of per SOP-00821, Pharmacovigilance and Technical Complaint Reporting., • Perform other duties as assigned. Core Values This position is expected to operate within the framework of Tolmar’s Core Values: • Center on People:We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.​, • Are Proactive & Agile:We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.​, • Act Ethically:We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace., • ​Constantly Improve:We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.​, • Are Accountable:We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.​ Knowledge, Skills & Abilities • Highly motivated for success with a “can do” attitude., • Excellent interpersonal, written and verbal communication skills and organizational skills, • Skill in negotiation and selling techniques as aligned with company expectations with demonstrated accountability in executing sales plans., • Aptitude for learning technical and scientific product relation information., • Demonstrate assertive selling techniques including asking for business on every call., • Excellent analytical skills and proven strategic thinker., • Ability to work independently and manage multiple projects both inside and outside the organization., • Ability to execute effective business plans for assigned territory., • Ability to develop working relationships with both internal and external customers and work as a team player with employees at all levels., • Ability to take initiative in the absence of precise direction., • Ability to demonstrate good judgment, discretion and compliance to industry ethical guidelines., • Ability to be approved and insured to drive company fleet vehicle, including valid driver’s license and good driving history., • Knowledge of Microsoft Office products, CRM systems and virtual platforms. Education & Experience • Bachelor’s degree in science, business or related field., • Consistent and proven track record of exceeding sales quotas., • 5 or more years of successful independent pharmaceutical and/or business-to-business sales experience, Pediatric Endocrinology, Rare Disease and/or Buy and Bill sales experience preferred., • Reside within the territory and willingness to cover the entire assigned geographical sales space., • Pharmacy sales experience is preferred, including Specialty Pharmacy, Health System Based Pharmacies etc., • Clinical experience helpful. Working Conditions • Role requires sitting, driving and standing., • Overnight travel is required for up to 75% of work week, dependent upon geographic footprint coverage expectations, • Ability to lift 50 pounds., • Travel by air as required., • Availability to work extra hours and on weekends as necessary. Compensation Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience. The pay range for this position at commencement of employment is expected to be between ($140,000 and $175,000/year); however, while salary ranges are effective from 1/1/26 through 12/31/26, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. About Tolmar Tolmar is proud to have earned a reputation for performance and innovation. Through a progressive company culture, Tolmar has established a legacy as a trusted name in the research, development and manufacturing of high quality topical products used in dermatology, and extended release dosing forms for products commonly used in urology and oncology. Founded in 2006, we are a private company known internationally for our advanced drug delivery capabilities and our unmatched commitment to our partners, and to the patients and provider communities we serve Since our inception, Tolmar has produced 22 marketed products supported by 5 New Drug Applications (NDAs) and 17 Abbreviated New Drug Applications (ANDAs) across urology and oncology and dermatology. With more products forthcoming, our dedicated pipeline reflects Tolmar’s future-focused approach Tolmar offers exciting opportunities that will leverage your abilities, expand your skills, and reward your contributions in an atmosphere that encourages both personal and professional growth. Additionally, Tolmar offers competitive compensation and excellent benefits including: • Competitive and inclusive medical, dental and vision coverage options, • Flexible Spending Accounts for medical expenses and dependent care expenses, • HSA through our HDHP, • CompleteCare reimburses you and your dependents for eligible health care expenses and premium expenses incurred under alternate group health coverage, • Generous 401K match - currently match 100% of your contributions up to the first 6% of compensation and 50% from 7%-12%, but never greater than 9%, • Tolmar-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options, • Employee Assistance Plan, Legal Guidance and Funeral Planning & Concierge Services, • Adoption and family-planning benefits, Fertility and Family Forming Benefits, • Generous paid time off, including:, • Vacation, sick time and holidays, • Volunteer time to participate within your community, • Discretionary year-end shutdown See More @ https://tolmar.com/working-at-tolmar/ We provide a positive work environment designed around the philosophy of mutual respect and the challenge and rewards of contributing to the continued success of our organization. Tolmar is committed to fostering, cultivating and preserving a culture of diversity, equity and inclusion. Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Sr. Director, Biostatistical Consulting (SrDBiosC) to join our A-team (office-based*/remote). As a (SrDBiosC) at Allucent, you are responsible for assisting in the coordination of statistical consulting services within the Biostatistics and Statistical Programming Department. This includes management of direct reports, ensuring appropriate resourcing allocation, and supporting business development and proposal needs. This position contributes to the department, the business unit, and Allucent financial and operational goals. The SrDBiosC, interacts with the BIOSC team and Allucent biostatistics and statistical programming team members, direct reports, executive leadership, other Allucent functional groups and business units. This position maintains compliance with relevant SOPs, regulatory guidelines, and client expectations. The SrDBiosC, provides statistical consulting to sponsors to support clinical program development, protocol development, sample size and endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions. The SrDBiosC is a senior member of BIOSC and supervises according to the organizational chart. In this role your key tasks will include: • Provide statistical consulting to sponsors to support clinical program development, protocol development, sample size calculations, endpoint selection, regulatory interactions, exploratory analyses, scientific meetings, and executive decisions, • Provide statistical consulting for complex and/or novel statistical analyses, • Provide statistical consulting to support clinical development strategies, including extensive interface with client executive and leadership teams, • Provide input and support responses to regulatory questions on statistical issues relating to client regulatory submissions, interacting with and attending meetings with regulatory bodies as applicable, • Prepare statistical analysis plans (SAPs) and table, listing, and figure (TLF) mocks for any complexity of study, • Provide senior reviews of statistical documents, data, and outputs for studies of all complexities to ensure quality and integrity, • Execute a statistical analysis of any complexity as specified in a protocol or analysis plan, • Interpret and communicate results for complex statistical analyses and outputs, • Develop and/or review the statistical sections of a study protocol for studies of any complexity level, • Review statistical sections of a clinical study report to ensure accurate descriptions of statistical methods used and results of analyses, • Provide randomization materials including randomization schedules and treatment kit lists per Allucent SOPs and the sponsor-approved specifications, • Develop or review documents for integrated analyses (e.g. ISS/ISE), including integrated SAPs and statistical sections of integrated study reports, • Working knowledge of SAS® for production and validation of datasets and statistical outputs, • Write and review specifications for complex ADaM or analysis datasets · Annotate or review annotations of TLF mocks to assist programming efforts, • Working knowledge of CDISC standards, • Review CRF design to ensure it conforms with the study protocol and analysis needs, • Review data management documents as requested to ensure integrity of study data, • Lead highly complex projects by fulfilling the following responsibilities: communicate with the client and statistical team, set and achieve timelines and milestones, ensure proper execution of the study SAP, monitor programming efforts in collaboration with the lead programmer, and work with management to ensure adequate resourcing, • Function as the lead unblinded statistician for studies and manage unblinded tasks including implementation of interim analyses and participation in DMC/safety review meetings, • Accountable for leading biostatistics and programming activities for a program of studies of high complexity and/or of high value., • Identify high-risk or high-impact deliverables and assign appropriate oversight, • Lead and manage project budgets, support financial reporting for studies, identify of out-of-scope work and provide leadership in change order process, • Collaborate with and verify open communication with other functional areas and business units, • Provide biometrics leadership and coordination across client and other vendor functional areas, including clinical operations, pharmacovigilance, regulatory, and medical writing teams, • Represent Allucent at proposal bid defenses and/or marketing meetings with prospective clients, • Provide key input into project proposals and budgets, • Establish positive relationships with current and future clients, • Identify key accounts and maintain strong long-lasting relationships to win new and repeat business, • Monitor and assure client satisfaction on existing projects for biostatistics and statistical programming, • Contribute to BIOSC, BBU, and corporate marketing activities via blogs, webinars, white papers, and other publications and presentations, • Contribute to other areas of business and assignments as required To be successful you will possess: • Graduate degree (Master’s degree/local equivalent, or higher) in a relevant discipline including, but not limited to, statistics, mathematics, life science, epidemiology, or healthcare, • Must have strong experience in Bayesian designs specifically in oncology studies., • Minimum 15 years of relevant work experience, • Minimum 10 years of experience in drug development and/or clinical research, • Thorough knowledge of GxP, • Strong familiarity with relevant regulations and guidelines, • GDPR/HIPPA, CFR/CTR/CTD and applicable (local) regulatory requirements, • Working knowledge of computer systems, applications and operating systems, • Demonstration of critical thinking and analytic skills, • Broad knowledge of drug development, • Ability to simplify complex issues into understandable concepts, • Proficient with one or more sample size software packages, • Strong technical skills with proficiency in SAS and/or other statistical programming languages, • Strong written and verbal communication skills including good command of English language, • Collaborative and client-focused, • Ability to work in a fast-paced challenging environment of a growing company, • Administrative excellence, • Strong leadership skills, • Effective at problem solving, strategic thinking and conflict resolution, • Strong presentation and networking capabilities, • Excellent organizational, negotiating and financial skills, • Knowledge of SAS, • Proficiency with various computer applications such as Word, Excel, and PowerPoint, • Strong individual initiative, • Excellent attention to detail and commitment to quality, • Ability to establish and maintain effective working relationships with co-workers, managers, clients, and vendors, • Ability to effectively manage multiple tasks and projects, • Reputation as a leader with sustained performance and accomplishment Benefits of working at Allucent include: • Comprehensive benefits package per location, • Competitive salaries per location, • Departmental Study/Training Budget for furthering professional development, • Flexible Working hours (within reason), • Opportunity for remote/hybrid* working depending on location, • Leadership and mentoring opportunities, • Participation in our Buddy Program as a new or existing employee, • Internal growth opportunities and career progression, • Financially rewarding internal employee referral program, • Access to online soft-skills and technical training via GoodHabitz and internal platforms Disclaimers: *Our office-based work policy encourages a dynamic work environment, prescribing a minimum of 2 days in office per week for employees within reasonable distance from one of our _. “The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #LI-Remote #LI-Hybrid #LI-TCW

POSITION SUMMARY: Natera is seeking a highly motivated and experienced Clinical Scientist to support the development and execution of our innovative Oncology programs. The Director, Clinical Science will ensure the successful execution of clinical development programs and deliverables in partnership across the organization, with external vendors, and with external academicians and collaboration partners. The Director, Clinical Science will be accountable to jointly develop clinical program strategy and work collaboratively together with other functional representatives to assure that activities are executed within expected scope, compliance, budget, and timelines. Specifically, the candidate will work closely with colleagues cross functionally in clinical development, clinical operations, data management safety/pharmacovigilance, regulatory, biostatistics, translational medicine, and program leadership. PRIMARY RESPONSIBILITIES: • Develop study concepts, including study design, schedule of assessments, objectives/endpoints, and eligibility criteria, • Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required, • Provide protocol training and contribute to CRF design, • Ensure study manuals align with protocol and engage investigators in study design, • Seek input from key investigators on study design and methodology to ensure alignment with research objectives, and actively participate in pre-site selection discussions, site initiation visits, and investigator meetings to support successful study execution, • Contribute to and oversee real-time clinical data reviews (including oversight of CROs when applicable), • Serve as a clinical science representative on internal and external meetings, • Develop clinical project execution timelines and provide status updates to senior management to ensure the timely delivery of program milestones, • in collaboration with Data Management will develop Data Review Plan, and monitor clinical data for specific trends, ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming, • Support meetings (advisory boards, etc) and deliver presentations, • Drive clinical research plans, including company and investigator-initiated studies, • Effectively interact with senior members in other functional areas for strategic planning to ensure optimized clinical development in accordance with corporate objectives, • Build relationships with KOLs, consortiums, and sites, • Provide scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for registration of the product, • As appropriate, participates in ongoing enhancements/development of team processes, structures, systems, tools, and other resources; As appropriate, coaches and guides less experienced Clinical Scientists, • Manage one or more direct reports including being responsible for hiring, training, developing, and retaining talent on staff, as needed, • As appropriate, participates in competitive intelligence and/or other market/industry assessment activities and projects, • Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment, • Ensure HIPAA/PHI compliance and maintain training requirements, • Perform other duties as assigned QUALIFICATIONS: • Advanced degree in Life Sciences (MD, PhD, Pharm D, MS, RN or similar scientific field) preferred, • 10+ years of pharma/biotech industry experience in clinical development in oncology clinical trials, • Deep understanding and preferably experience in oncology molecular diagnostics, oncology companion diagnostics or early cancer detection, • Experience in data review, data cleaning, managing and interpreting clinical trials results as well in writing clinical trial protocols, • Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research, • Experience with managing direct reports, ensuring that roles are performed in accordance with job descriptions and that training is conducted and maintained appropriately KNOWLEDGE, SKILLS, AND ABILITIES: • Problem-solving skills and a fast learner, • Strong communication (oral and written) and attention to detail, • Ability to work independently and collaboratively, • Analytical and creative thinking, • Familiarity with Google and Microsoft suites, • Desire to work in a dynamic environment, • "Hands-on" leadership and a strong work ethic, • Ability to apply business knowledge, exercise judgment, and escalate issues appropriately, • Strong project management, organizational, and interpersonal skills, • Adaptability, initiative, and team-building skills, • Demonstrated success in working in a cross-functional environment, • Successful and superior influencing skills across all levels of the organization and external collaborators, • Conflict resolution and follow-through skills, • Results and goal-oriented, • Strategic and flexible thinking PHYSICAL DEMANDS & WORK ENVIRONMENT: • Office or home office setting with internet access, • Ability to use a computer, phone, and read materials, • Flexibility to work with colleagues in a global setting, • Able to engage in work-related travel up to 25% The pay range is listed and actual compensation packages are based on a wide array of factors unique to each candidate, including but not limited to skill set, years & depth of experience, certifications and specific office location. This may differ in other locations due to cost of labor considerations. Remote USA $192,600 - $240,800 USD OUR OPPORTUNITY Natera™ is a global leader in cell-free DNA (cfDNA) testing, dedicated to oncology, women’s health, and organ health. Our aim is to make personalized genetic testing and diagnostics part of the standard of care to protect health and enable earlier and more targeted interventions that lead to longer, healthier lives. The Natera team consists of highly dedicated statisticians, geneticists, doctors, laboratory scientists, business professionals, software engineers and many other professionals from world-class institutions, who care deeply for our work and each other. When you join Natera, you’ll work hard and grow quickly. Working alongside the elite of the industry, you’ll be stretched and challenged, and take pride in being part of a company that is changing the landscape of genetic disease management. WHAT WE OFFER Competitive Benefits - Employee benefits include comprehensive medical, dental, vision, life and disability plans for eligible employees and their dependents. Additionally, Natera employees and their immediate families receive free testing in addition to fertility care benefits. Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. We also offer a generous employee referral program! For more information, visit _. Natera is proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities and perspectives. Inclusive collaboration benefits our employees, our community and our patients, and is critical to our mission of changing the management of disease worldwide. All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status. We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. If you are based in California, we encourage you to read this important information for California residents. Link: _ Please be advised that Natera will reach out to candidates with a @_ email domain ONLY. Email communications from all other domain names are not from Natera or its employees and are fraudulent. Natera does not request interviews via text messages and does not ask for personal information until a candidate has engaged with the company and has spoken to a recruiter and the hiring team. Natera takes cyber crimes seriously, and will collaborate with law enforcement authorities to prosecute any related cyber crimes. For more information: • _, • _

This job is with Pfizer, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. Job Summary The medical director provides Clinical Development leadership and expertise on Late phase clinical trials, including overseeing the design, conduct, and analysis within Hematology. The medical director works closely with other functions such as regulatory affairs, pharmacovigilance, biostatistics, and medical affairs to ensure that the clinical development program meets the scientific, ethical, and regulatory standards. The medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, and patient advocacy groups. Job Responsibilities Study-level Clinical Development Leadership · Collaborate with Clinical Scientist(s) to provide clinical leadership across 2-3 study team(s) that is scientifically rigorous and aligns with company objectives. · Conduct medical monitoring activities including eligibility assessment, data review and safety monitoring. · Lead peer-to-peer interactions with investigators. · Serve as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities. · Lead and contribute to development and maintenance of clinical trial and regulatory documents, in collaboration with Clinical Scientist and the cross-functional team. Strategic Guidance, Clinical Insights & Interpretation · Collaborate with Clinical Scientist to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders. · Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans. Basic Qualifications • Medical degree Required with 4 + years experience, • Clinical Development experience required, • 2-4 years industry experience required Preferred Qualifications • Late-stage clinical development experience preferred, • Hematology experience preferred, • Board certified/eligible in oncology or equivalent preferred Organizational Relationships Reports to Global Development Lead or Senior/Executive Medical Director Partners closely subject matter experts within cross-functional study team, Pfizer Oncology Division and counterparts in other divisions within Pfizer. Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Ability to travel to conferences and for team meetings ~4 times per year Relocation assistance may be available Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week The annual base salary for this position ranges from $239,900.00 to $399,800.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Candidates must be authorized to be employed in the U.S. by any employer. U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to make accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Medical

Associate Director Safety Scientist to lead safety evaluation and analysis in the drug development process. The ideal candidate will have a PharmD or PhD with extensive experience in pharmacovigilance and clinical development.

As a Manager within Kearney's Healthcare & Life Sciences Practice, you will play an important role in supporting the growth and development of our Pharma R&D Strategy offering. You will work closely with clients and internal teams to develop strategic insights and deliver high-impact outcomes across complex pharmaceutical R&D and clinical development challenges. We are seeking experienced consultants with expertise across Pharma R&D, particularly those with a traditional consulting background advising biopharma clients on clinical development, drug development strategy, operating models, and R&D transformation initiatives. This role is focused on strategic advisory work rather than operational program execution. Ideal candidates will bring strong hypothesis-driven problem solving, executive communication skills, and experience managing complex strategy engagements within pharmaceutical R&D organizations. Key responsibilities: • Support and manage strategy engagements for pharmaceutical and biopharma clients across R&D and clinical development functions, • Advise clients on topics including clinical development strategy, drug development strategy, clinical operations, regulatory affairs, pharmacovigilance, clinical trial feasibility, and R&D operating models, • Support digital strategy and transformation initiatives across Pharma R&D organizations, • Drive strategic problem solving from analysis through executive recommendation development, • Manage engagement workstreams and collaborate with cross-functional teams to deliver high-impact client outcomes, • Contribute to proposal development, business development activities, and growth of Kearney's Pharma R&D Strategy capabilities, • Mentor junior consultants and support a collaborative, high-performing team environment Who you are: After nearly 100 years, we know this business is fundamentally about making connectionsbetween facts, figures, insights, strategies, tools, technologies, and above all, people. That's why we look for collaborative, insightful, and inquisitive problem-solvers who don't accept the first thing in front of them and who are always unapologetically themselves. We want to hear from you if you have: • MBA preferred and 8+ years of professional experience, • Relevant management consulting experience with exposure to strategy engagements within Pharma R&D and clinical development, • A strong consulting background with experience supporting strategic advisory engagements within pharmaceutical and biopharma organizations, • Experience advising clients across one or more of the following areas: clinical development, drug development, clinical operations, regulatory affairs, pharmacovigilance / drug safety, clinical trial feasibility, clinical development program strategy, R&D operating models, digital strategy and transformation within R&D organizations, • Deep pharmaceutical industry expertise; candidates focused primarily on medtech or consumer health are less aligned for this role, • Demonstrated ability to support strategic advisory engagements versus operational execution-focused delivery work, • Strong communication skills and executive presence, • Experience supporting proposal development, client pitches, and business development activities, • Proven ability to independently manage multiple complex workstreams, • Exceptional analytical, problem solving, and leadership skills, • Willingness to travel as required What we can offer you: Every day, our people work to be the difference for our clients, our communities, and our colleagues. Helping them make an impact, they are sustained by a competitive remuneration package plus comprehensive benefits and perks, including but not limited to: generous retirement/pension savings contributions, comprehensive medical insurance for employees and immediate family, gym membership discounts, non-partner equity-based awards (for consulting managers and above), structured and on-the-job learning and development opportunities, personalized opportunities including talent mobility, flexible work programs, and externships to help you chart a unique career journey to pursue your own personal and professional goals. Manager base salary $212,000-$235,000. It is important to note that at Kearney, it is not typical for an individual to be hired at the top of the range for their role. Individual salaries within each range are determined through a wide variety of factors including but not limited to education, experience, knowledge and skills. Kearney reviews compensation regularly and may adjust base salaries to reflect market competitiveness. In addition to salary, individuals may be eligible for a discretionary performance bonus. Our full suite of benefits includes paid time off, 401(k) match and profit sharing, medical, dental and vision coverage, healthcare concierge, backup child/adult care, annual employer HSA contribution, home office stipend, subsidized Gympass and annual wellness program, and leaves of absence when needed to support employees' physical, mental, and emotional well-being. Equal Employment Opportunity and Non-Discrimination: Kearney prides itself on providing a culture that allows employees to bring their best selves to work every day. Our people can feel comfortable, confident, and joyful to do great things for our firm, our colleagues, and our clients. Kearney aims to build diverse capabilities to help our clients solve their most mission critical problems. Kearney is committed to building a diverse, unbiased and inclusive workforce. Kearney is an equal opportunity employer; we recruit, hire, train, promote, develop, and provide other conditions of employment without regard to a person's gender identity or expression, sexual orientation, race, religion, age, national origin, disability, marital status, pregnancy status, veteran status, genetic information or any other differences consistent with applicable laws. This includes providing reasonable accommodation for disabilities, or religious beliefs and practices. Members of communities historically underrepresented in consulting are encouraged to apply.

As a Senior Business Analyst within the Pharmacovigilance group at our client you will play a key role in ensuring the effectiveness and efficiency of our drug safety operations. You will be responsible for analyzing and improving business processes, implementing technology solutions, and ensuring that our pharmacovigilance activities align with regulatory requirements and industry best practices. The ideal candidate will have a strong background in drug safety and pharmacovigilance, combined with excellent business analysis skills. • Business Analysis and Process Improvement:, • Analyze current pharmacovigilance processes and systems to identify areas for improvement., • Develop and implement strategies to enhance efficiency, data quality, and compliance in drug safety reporting., • Liaise between the pharmacovigilance team, IT department, and external stakeholders to ensure effective communication and project success., • Technology Implementation and Management:, • Lead the implementation of new pharmacovigilance software and tools., • Oversee the customization and optimization of existing systems to better meet pharmacovigilance needs., • Ensure technology solutions are compliant with regulatory standards such as EMA, FDA, and ICH guidelines., • Data Analysis and Reporting:, • Analyze safety data to identify trends, patterns, and potential risks., • Prepare and present reports to senior management, regulatory authorities, and key stakeholders., • Support the creation of risk management plans and safety update reports., • Regulatory Compliance and Documentation:, • Stay abreast of regulatory changes and updates in pharmacovigilance., • Ensure that all pharmacovigilance activities and documentation comply with regulatory requirements., • Assist in preparing for audits and inspections., • Stakeholder Collaboration:, • Collaborate with cross-functional teams including clinical research, regulatory affairs, and quality assurance., • Provide training and guidance to team members on pharmacovigilance processes and systems., • Project Management:, • Manage and oversee pharmacovigilance-related projects from inception to completion., • Develop project plans, timelines, and budgets, ensuring timely and cost-effective delivery., • Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field., • Minimum of 8 years of experience as a Business Analyst ideally in pharmacovigilance and drug safety within the pharmaceutical industry., • Strong understanding of pharmacovigilance regulations and reporting requirements., • Proven experience in business analysis, process improvement, and project management., • Excellent analytical, organizational, and communication skills., • Proficient in pharmacovigilance databases and software., • Ability to work collaboratively in a team environment and manage multiple priorities., • Experience with data analytics and reporting tools., • Knowledge of risk management and quality assurance in pharmacovigilance., • Certification in Business Analysis (e.g., CBAP, PMI-PBA).

Experience level: Mid-senior Experience required: 5 Years Education level: Bachelors degree Job function: Accounting/Auditing Industry: Pharmaceuticals Pay rate : View hourly payrate Total position: 1 Relocation assistance: No Visa sponsorship eligibility: No The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials. Plan and conduct audits of specific clinical processes based on risk. Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor. Develop audit reports and distribute them to appropriate stakeholders. Own and manage related clinical vendor non-conformances. Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc). Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors. Support the preparation, coordination, and participation of regulatory agency inspections. Participate in and support quality improvement projects. 5+ years of pharmaceutical experience BS degree in scientific, health care or related discipline Intensive GCP and safety background Experience with both internal and external process and systems audits Strong knowledge of development policies, procedures and standards (SOPs, QMS) Ability to work with global clinical teams in developing objectives for audits of clinical studies 10% Traveling required Paramus, NJ, United States ESR Healthcare

Paramus, New Jersey, United States The GCP Quality Assurance Sr. Auditor will report to the Director the GCP/PVG Quality Assurance. This position will be focused on ensuring GXP compliance with regulatory authorities, driving and implementing the Companys compliance directives and supporting quality management systems to ensure compliance and minimize risk in a regulated pharmaceutical environment. The incumbent will conduct and or participate in all GXP QA audit programs which include both internal and external GXP audits. This position will provide day to day support to the GXP QA Director in clinical operations/Non-clinical and Manufacturing to manage CROs, CMOs, investigator sites, and all relevant vendors to support clinical trials. The Sr. Auditor of Quality Assurance will work with the QA and cross functional teams, communicate with QA consultants and has contact with external auditees, vendors, partners and affiliates. The ideal candidate will have extensive GCP experience. This opportunity is with a rapidly growing biopharmaceutical company that specializes in Neurology and Psychiatry therapies. They are based in Northern New Jersey and require the candidate to be on-site. Performs and manages all types of audits in the audit program of Clinical Development and Safety Pharmacovigilance. • Plan and conduct scheduled global clinical process and clinical vendor audits across all clinical trials., • Plan and conduct audits of specific clinical processes based on risk., • Perform clinical vendor audits along with various SMEs (IRT, EDC etc.) to comprehensively assess all services provided by a vendor., • Develop audit reports and distribute them to appropriate stakeholders., • Own and manage related clinical vendor non-conformances., • Review, understand, and audit clinical related regulations and guidelines (e.g. FDA regs, GCP, etc.)., • Collaborate with clinical sourcing, supplier quality and clinical partnership to manage clinical vendors., • Support the preparation, coordination, and participation of regulatory agency inspections., • Participate in and support quality improvement projects., • 5+ years of pharmaceutical experience, • BS degree in scientific, health care or related discipline, • Intensive GCP and safety background, • Experience with both internal and external process and systems audits, • Strong knowledge of development policies, procedures and standards (SOPs, QMS), • Ability to work with global clinical teams in developing objectives for audits of clinical studies, • 10% Traveling required

Job Description We invite you to join our mission of advancing the prevention and treatment of diseases. The purpose of Global Labeling is to drive labeling strategy and ensure high-quality and compliant labeling documents which provide the safe and effective use of products for patients and healthcare providers globally. Responsibilities The Principal Scientist, Global Labeling Lead is responsible for: developing, maintaining, and implementing Core Labeling and target labeling for assigned products in line with internal standards and guidelines- Developing, maintaining, and implementing US Labeling for assigned products in line with regulatory requirements and internal standards and guidelines- Assisting with developing and maintaining Local Labeling (EU and most of world) for assigned products-- Providing labeling expertise and guidance to teams, assimilating labeling precedence and competitor labeling, while ensuring compliance with applicable regulatory requirements- Serving as regulatory labeling point of contact on global Regulatory Affairs sub‑teams to ensure delivery of labeling documents that meet quality and compliance standards and regulatory labeling requirements to support timely regulatory submissions for assigned products- Leading (both direct reports and cross‑functional teams) to develop, review and approve Core and Local Labeling documents- Independently recommending strategies and labeling language for inclusion in Core or Local Labeling during labeling development or responses to Health Authority-- Providing information to Global Labeling Compliance, as required, to support internal and external (i.e., Regulatory Authority) requirements and support audits/inspections as a labeling subject matter expert- Evaluating risks associated with Core or Local Labeling content, developing mitigation strategies, and appropriately escalating issues to Global Labeling management and the Global Regulatory team- Proficiency in crucial labeling requirements worldwide- Contributing to the continuous improvements to the end-to-end labeling process, including labeling policies, procedures, quality, and system tools- Providing guidance, coaching, training and may provide management support to other Global Labeling Leads- Education Required: Bachelor’s degree in a scientific or medically related discipline. Preferred: Advanced degree (M.S., Pharm.D., Ph.D.). Required Experience & Skills Minimum of 7 years of labeling experience or relevant experience in the pharmaceutical industry (e.g., Medical Affairs, Regulatory Affairs, Clinical, Pharmacovigilance)- Skilled and effective at leading and mentoring team members and leading cross‑functional labeling team (including senior management), exhibiting a combination of active listening skills and the confidence to address labeling issues, develop plans of action, drive consensus, and oversee completion of labeling project.-- Independent ability to assimilate clinical and scientific information, including labeling precedent and competitor labeling, and present it concisely. Understanding of medical concepts and terminology and how it applies to regulatory requirements and labeling strategy- Strong project management skills with the ability to handle multiple projects and prioritize work accordingly- Proactive problem‑solving ability with the ability to make appropriate recommendations/decisions- Tolerance for ambiguity and action-oriented- Excellent written and oral communication skills- Strong interpersonal skills- Attention to detail and accuracy- Ability to influence and negotiate- Required Skills Adaptability Clinical Judgment Data Quality Assurance Detail‑Oriented Innovation Policy Implementation Publications Management Records Retention Management Regulatory Compliance Audits Regulatory Submissions Regulatory Training Team Collaboration Technical Documentation Management Technical Writing Training and Development Benefits We offer a comprehensive package of benefits including medical, dental, vision, and other insurance benefits for employee and family, retirement benefits including 401(k), paid holidays, vacation, and compassionate and sick days. Salary Range $173,200.00 - $272,600.00 Compensation The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Legal Statements As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. We provide information and accommodations for applicants with disabilities upon request. Eligibility US and Puerto Rico residents only. Staff may also be considered for qualified applicants in San Francisco and Los Angeles pursuant to local fair chance ordinances. No relocation required. Other Information Employee Status: Regular. VISA Sponsorship: None. Travel Requirements: 10%. Flexible Work Arrangements: Hybrid. Shift: Not indicated. #J-18808-Ljbffr

Candidates must be located in Central Europe Company Overview: RxLogix is a global leader in pharmacovigilance solutions, providing innovative software and expert consulting services. Our team collaborates with Pharmacovigilance and Risk Management professionals to enhance compliance, productivity, and quality across the drug safety value chain. Dedicated to patient safety and the advancement of medical and scientific research, RxLogix values bold, innovative thinkers. We leverage the latest technologies, including machine learning and artificial intelligence, to set new industry standards. Recently, the FDA selected RxLogix's PV Surveillance Suite Platform to replace its legacy FAERS signaling system, utilizing our modules for advanced data analytics, signal detection, evaluation, signal management, and benefit-risk assessment. General Purpose: • The Director, Business Development will report directly to the Vice President of Business Development for US and Europe of RxLogix., • Managing territory by selling directly into pharmaceutical companies and Contract Research Organizations (CROs)., • Build and work the entire sales pipeline from prospecting for new business, to cold-calling, to getting client meetings, to closing business., • Candidate should have a hunger for personal and company success and enjoy working on a high functioning, competitive, and collaborative team., • Our Sales team is responsible for introducing our suite of solutions, to new customers and driving new business for the company in the US and Europe., • Previous pharma experience and clinical trials experience is preferred., • Software Sales Manager will play an important and highly visible role in liaising with key executives in the life sciences industry., • One of our core values is working as a team, and we expect our sales team to live and breathe team collaboration to ensure the team's and RxLogix success. Essential Duties & Responsibilities: • Penetrate, profile, qualify and schedule well-qualified appointments with key decision makers within targeted US and EU life science companies, • Cold-call, network, and email a high volume of prospects and sales operations leaders, and utilize resources to build and maintain the sales pipeline., • Learn and demonstrate a solid understanding of RxLogix technology, and clearly articulate capabilities and advantages to prospective customers to successfully manage and overcome prospect objections., • Comprehensively introduce and explain our solutions via web meetings., • Effectively position and liaise with prospects ranging from end-users, to Directors, VP, to the CX level., • Achieve and exceed monthly sales quotas., • Work closely with the US and EU Sales Director and marketing team members to achieve organizational goals., • Provide continual input to the sales and marketing organizations to refine positioning and adapt to new market opportunities., • Generate new business and sales leads through a mixture of cold calling and following up on marketing campaigns and inbound inquiries., • Work with existing clients to grow their accounts and find referrals., • Schedule meetings with target accounts., • Manage inbound leads., • Make outbound calls to targeted accounts., • Understand programs and offerings and effectively communicate and apply them to each prospect need. Minimum Requirements: • Located in Central Europe, • 5-10 years of direct sales experience with proven achievement of sales targets, along with a track record of successfully selling enterprise software solutions (preferably SaaS)., • Previous experience selling into the pharmaceutical and CRO industry is preferred., • Previous experience with selling Pharmacovigilance and Drug Safety Software., • Previous experience presenting online to a wide variety of clients, including senior level executives, and proven success closing the sale., • Ability to stand up in front of executive and articulate a business case., • Travel up to 30-40% of the time., • Customer oriented background required (sales, support, customer service)., • Qualities of cooperation, adaptability, flexibility as changes occur in the department, and maintaining a positive attitude., • Solid understanding of web, enterprise, and SaaS technologies., • Willingness to roll up your sleeves and do what it takes to get the job done., • Ability to change priorities quickly, and the capacity to multi-task., • Strong interest in technology, and the ability to clearly explain even the most complicated ideas to a non-technical audience.

Overview Experienced Clinical Research Associate - Full-Service Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection. Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 75% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. Benefits At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr

Experience advising pharmaceutical and biopharma clients across one or more of the following areas: Clinical development Drug development Clinical operations Regulatory affairs Pharmacovigilance / drug safety Clinical trial feasibility Clinical development program strategy R&D operating models Digit

The Worldwide Patient Safety group is responsible for pharmacovigilance and pharmaco-epidemiology deliverables including single case and aggregate safety monitoring, safety reporting, contribution to benefit-risk assessment, risk management planning and strategy, and execution of certain post-market

Capgemini Invent - LS Pharmacovigilance, Sr Consultant. As a Senior Consultant, you will act as a pharmacovigilance and drug safety expert for pharmaceutical and biotech clients, supporting safety across the product lifecycle - from clinical development to post-market. This role offers opportunities

Regulatory Affairs (MRL, GRACS).Education: Minimum BS Degree preferably in technical, business or science.Required Experience: At least 12 years in the pharmaceutical industry with at least 5 years in Regulatory/Pharmacovigilance Function or Alliance or Business Development.Ability to influence and

Experience in training adult learners and developing procedural documents and training materials. Monitors and tracks training compliance with the LMS. Provides Standards & Training subject matter insights within and outside of the PSPV function.

A leading biotech company is seeking a Head of Drug Safety to build and oversee the global pharmacovigilance function.

Medical Director for Drug Safety and Pharmacovigilance.

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Clinical Scientist - Cardiovascular Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. Collaborates with study team members including Clinical Operations, Data Management, Drug Safety and Pharmacovigilance, and Project Managemen

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The Senior Director of Pharmacovigilance and Safety will require a deep understanding of pharmacovigilance regulatory requirements, product safety issues, safety operational support, strong vendor management oversight, understanding of compliance metrics, providing strategic input on all things safe

Responsibilities Translate documents from Turkmen to English with a focus on life sciences and pharmacovigilance terminology Ensure accuracy and clarity in translations to meet regulatory standards Review and edit translated materials for quality assurance Collaborate with project managers to me

A leading biotech company seeks a Global Safety Officer to oversee pharmacovigilance for Rare Disease products in Idaho.This role includes shaping safety strategy, leading cross-functional teams, and ensuring product safety compliance.Candidates should have an MD or DO degree, complete residency, an

Ability to understand complex medical-scientific data from a broad range of disciplines (eg, clinical trial laboratory data, nonclinical data, postmarketing reports, scientific literature, and regulatory documents).

Our client is a leading provider of Pharmacovigilance Technology Solutions. They bring deep expertise in drug safety, paired with advanced technology, including AI and GenAI. Their innovative solutions tackle the most pressing challenges in the pharmaceutical industry. These solutions drive both operational efficiency and enhanced business performance. Their offerings include proprietary products for automated case intake, advanced reporting platforms, GenAI-based solutions, and expert services such as Business Transformation, Safety Systems Consulting (Argus, ArisG), Data Migration, and Computer System Validation. These flexible and scalable solutions are designed to meet the needs of both large global companies and smaller organizations across diverse markets. With a focus on improving data accuracy, optimizing workflows, and ensuring patient safety, their solutions enable clients to address regulatory requirements while reducing operational costs. By streamlining complex safety processes, they empower pharmaceutical companies to drive lasting business value and maintain a competitive edge in a rapidly evolving industry. Job Description • Experience: 15 - 20 Years, • Location: Tri-State Area (NYC/ PA / NJ)/ Willing to commute Hybrid mode, • Employment: Full Time Key Role and Responsibilities o Project Leadership & Delivery: • Lead global technology projects for Life Sciences/Pharma clients, ensuring alignment with business goals, regulatory requirements, and successful on-time, on-budget delivery., • Drive the execution of project plans and milestones while coordinating with globally distributed internal teams, including offshore delivery teams., • Manage large-scale, multi-million-dollar projects with cross-functional teams across different time zones, ensuring smooth project execution and strong team collaboration. o Client & Stakeholder Management: • Own client relationships, aligning expectations with deliverables through proactive communication and regular updates., • Ensure clear, consistent communication with internal teams and external stakeholders, fostering strong collaboration throughout the project lifecycle., • Engage with executive-level stakeholders, regulatory bodies, and internal leadership to maintain alignment and transparency on project progress and outcomes. o Risk & Process Management: • Proactively identify and address risks to ensure smooth project execution and prevent potential disruptions., • Implement efficient program management processes, adhering to governance frameworks and methodologies, and utilize tools such as Jira and MS Project., • Ensure compliance with regulatory standards and internal governance protocols, providing risk mitigation strategies and action plans when necessary. o Financial & Operational Oversight: • Develop Statements of Work (SOW), build proposals, and deliver presentations to support project execution and business development., • Track the invoicing schedule in collaboration with the finance team to ensure timely billing and payments., • Collaborate with internal finance teams to ensure proper financial tracking and forecasting for project success. Behavioral Skills: • Demonstrated leadership in managing cross-functional teams and driving project success with global stakeholders., • Adaptability to meet evolving customer needs, prioritize effectively, and perform under tight deadlines., • Exceptional interpersonal and collaboration skills to build strong working relationships with diverse, globally distributed teams., • Strong critical thinking and decision-making skills to evaluate alternatives and present solutions aligned with business objectives., • Strong conflict resolution and problem-solving abilities, particularly in navigating complex project challenges and ensuring stakeholder alignment. Why Join Our client? Joining our team makes you part of a lean, people-centric work environment. Our culture encourages ownership and accountability, ensuring recognition for merit. We offer a nurturing ecosystem that helps you map your career, identifying strengths and leveraging them for both individual and organizational growth. We don't let people fail! Our team has decades of experience in engineering and deploying best-in-class life sciences solutions, with a proven track record of scaling operations globally in line with business demands. This environment offers ample opportunities for growth while contributing to impactful projects and shaping the future of the industry. You'll work with cutting-edge technology, lead impactful projects, and collaborate in a dynamic, diverse environment that fosters innovation and flexibility. Enjoy professional development and career growth, all within a highly supportive work culture focused on collaboration and continuous improvement.

Ideal candidates will have 6+ years of pharmacovigilance experience and a strong background in regulatory compliance. The successful candidate will support the regulatory affairs department and oversee pharmacovigilance vendors, ensuring safety compliance and effective analysis.

IQVIA is seeking a Sr Medical Safety Advisor to provide medical expertise in evaluating safety data in the pharmacovigilance process. A medical degree and strong communication skills are required. Key responsibilities include medical review of adverse events and aggregate safety reports, ensuring co

Beeline Medicines is looking for an Associate Director, Pharmacovigilance Scientist to oversee global drug safety activities remotely.

Be among the first 25 applicants Barrington James is partnered with a large research consultancy looking to bring on board a Pharmacovigilance Head on a part time contract. Responsibilities would include: Lead the company’s drug safety and pharmacovigilance strategy.

A leading biotechnology company in the United States seeks an Executive Director Pharmacovigilance Physician to drive compliance and develop risk management strategies in pharmacovigilance. This role requires over 10 years of experience in pharmacovigilance, with strong leadership and regulatory kno

Desired Skills and Experience Global Patient Safety Operations, Pharmacovigilance Operations, Clinical Safety Management, Global Safety Reporting, Safety Information Collection, Safety Case Processing, Regulatory Compliance, Global Regulatory Submissions, Safety Reporting to Health Authorities, IRB/

Requirements: MD or equivalent degree; additional training/experience with rare diseases is preferred 12 + years of relevant industry experience in biotech and/or pharmaceutical settings with significant time spent in senior leadership roles, including 5+ years of direct experience in Drug Safety

Key Responsibilities Build and lead the global Drug Safety organization Oversee all aspects of pharmacovigilance, including safety strategy, case processing, signal detection, and risk management Provide medical review and benefit–risk assessments across the product lifecycle Serve as the comp