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Job Description About Opus Regulatory: Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level of Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients. Multiple Openings | Remote | Senior Manager–Vice President Experience Levels Opus Regulatory's Labeling Strategy Practice is hiring Principal Consultants to support pharmaceutical and biotechnology clients across a variety of products, therapeutic areas, and global markets. In this role, you will combine strategic regulatory guidance with hands-on execution, helping clients develop and maintain labeling throughout product development, registration, and commercialization. As an embedded member of client teams, you will lead labeling initiatives, build cross-functional consensus, and guide labeling decisions that align scientific evidence, regulatory requirements, and program objectives. We welcome candidates with experience at the Senior Manager through Vice President levels who enjoy solving complex labeling challenges and contributing directly to client success. Key Responsibilities Serve as a regulatory labeling expert within client teams, advising on labeling strategy, content development, submissions, processes, and best practices. Lead the preparation, review, and maintenance of Target Product Labels (TPLs), Company Core Data Sheets (CCDSs), U.S. prescribing information, EU product information, and other regional or local labeling. Guide early-stage labeling strategy, partnering with development teams to identify labeling objectives, assess supporting evidence, and address potential gaps. Lead cross-functional labeling discussions, partnering with clinical, safety, medical, and regulatory stakeholders to resolve issues and drive consensus. Assess and communicate the regulatory implications of proposed labeling changes, including risks, regional considerations, and implementation strategies. Develop and manage labeling timelines and deliverables, coordinating content updates, submissions, and implementation across global markets. Support responses to regulatory authority requests and labeling negotiations, including preparation of supporting documentation and participation in agency meetings, as needed. Apply knowledge of end-to-end labeling processes, governance, and systems to support labeling operations and improve consistency and efficiency. Monitor evolving labeling requirements and guidance, advise client teams on their implications, and represent regulatory labeling in client meetings and related workstreams. Qualifications 8+ years of pharmaceutical or biotechnology regulatory affairs experience focused on labeling strategy, content development, and lifecycle management. Bachelor's degree required; an advanced degree in a scientific discipline preferred. Demonstrated experience developing and maintaining core, U.S., EU, and other regional labeling, with a strong understanding of global labeling requirements. Experience supporting labeling during product development and commercialization, including TPL and CCDS development and maintenance. Ability to provide both strategic counsel and hands-on support, with an understanding of labeling operations, governance, and supporting systems. Experience across multiple therapeutic areas highly desirable. Strong project management skills, including the ability to coordinate labeling submissions, manage competing priorities, and support regulatory inspection activities. Strong communication and collaboration skills, with the ability to interpret scientific information, communicate regulatory risks, and guide cross-functional teams toward consensus. Ability to work independently, exercise sound judgment, and develop practical solutions to labeling and operational challenges. At Opus Regulatory, we are committed to pay transparency and equitable compensation practices. Actual compensation will be determined based on factors such as experience, education, specialized expertise, geographic location, and internal equity. In select circumstances, compensation may fall outside of the posted range. US-Remote Pay Range $210,000—$300,000 USD Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.

Job DescriptionCompany Description At EVERSANA, we are proud to be a Great Place to Work across the globe. We’re fueled by our vision to create a healthier world. How? Our global team of more than 6,000 employees is committed to creating and delivering next-generation commercialization services to the life sciences industry. We are grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them. Our jobs, skills and talents are unique, but together we make an impact every day. Join us! Across our growing organization, we embrace diversity in backgrounds and experiences. Improving patient lives around the world is a priority, and we need people from all backgrounds and swaths of life to help build the future of the healthcare and the life sciences industry. We believe our people make all the difference in cultivating an inclusive culture that embraces our cultural beliefs. We are deliberate and self-reflective about the kind of team and culture we are building. We look for team members that are not only strong in their own aptitudes but also who care deeply about EVERSANA, our people, clients and most importantly, the patients we serve. We are EVERSANA. Job Description The Virtual Territory Business Manager (VTBM) is a virtual sales professional responsible for driving demand generation, customer engagement, and business performance within an assigned territory Reporting to the Regional Sales Director, this role supports both pre-launch and post-launch commercial activities and executes approved strategic and tactical plans to achieve territory objectives. The Virtual Territory Business Manager (VTBM) is a virtual sales professional responsible for driving launch readiness, successful product commercialization, and sustaining business growth within assigned territory through primarily digital and remote interactions. As the primary point of contact for the eye care community, the VTBM develops trusted partnerships with Retina specialists, comprehensive ophthalmologists, optometrists, genetic counselors, academic medical centers, referral networks, and other key healthcare stakeholders to educate on disease state, identify appropriate patients, and support the adoption of innovative therapies. By leveraging customer insights, market analytics, competitive intelligence, and territory performance data, the VTBM identifies opportunities, prioritizes accounts, anticipates barriers to adoption, and implements targeted strategies that accelerate market uptake and optimize territory performance. Working collaboratively with cross-functional partners including Market Access, Marketing, Medical Affairs, Commercial Operations, and other field-based teams, the VTBM ensures coordinated execution of launch strategies, customer engagement initiatives, and access solutions that enhance customer experience and support patient access. The Virtual Territory Business Manager must demonstrate effective virtual account management skills and engage nurses, pharmacists, physicians, genetic counselors, office administrators, and support staff through digital platforms to increase awareness of the brand and disease state. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Translate national brand strategy into a territory business strategy and corresponding tactical plan while meeting activity, access, and sales objectives., • Drive product adoption through pre-call planning, listening, probing, clinical messaging impact, and supporting complex patient access education., • Build and maintain proficiency in the disease state, patient journey and product knowledge to deliver compelling clinical and diseases state awareness aligned with approved messaging and compliance standards., • Conduct high-quality virtual customer engagements utilizing approved promotional materials, digital resources, and compliant messaging., • Establish and maintain productive relationships with ophthalmologists, retina specialists, inherited retinal disease (IRD) specialists, genetic counselors, and other key stakeholders through telephone, video conferencing, email, and approved digital communication channels., • Leverage digital engagement tools, analytics, and customer insights to prioritize opportunities and maximize business impact., • Exhibit an ownership mindset by emphasizing customer prioritization, thoughtful resource allocation, and an analytical view of opportunities., • Monitor and adapt based on lead/lag indicators (identified patients, referral pathways, diagnostic odyssey engagement, specialty pharmacy pull-through) and escalate competitive intelligence and field insights to sales leadership., • Maintain accurate and timely documentation of customer interactions, account plans, and territory activities within approved CRM systems., • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias., • All other duties as assigned. KEY COMPETENCIES: • Strategic thinking and execution excellence, • Demonstrated advanced clinically based selling skills, • Collaborative and adaptable ways of working, • High-level customer partnership and development, • Patient centric mindset, • Strong business acumen and market insight with an ownership mindset, • Cross-functional influence and collaboration, • Adaptability in complex, evolving markets COMMUNICATION SKILLS: • Effectively communicate approved clinical and scientific information related to the brand to healthcare professionals, ophthalmologists, IRD specialists, genetic counselors, and office staff through virtual engagements., • Deliver compelling disease state education and product information while remaining compliant with company policies and regulatory requirements., • Conduct impactful video meetings, virtual presentations, webinars, and remote educational programs with healthcare professionals and office personnel. #LI-CG1 Qualifications MINIMUM KNOWLEDGE, SKILLS AND ABILITIES: The requirements below represent the experience, education, knowledge, skills, and abilities needed for this role. Education: • Bachelor’s degree in a related field. Experience: • Minimum of 3-5 years of pharmaceutical, biotechnology, specialty healthcare sales, inside sales, virtual sales, or customer engagement experience with a demonstrated record of business success., • Ophthalmology experience strongly preferred., • Virtual pharmaceutical sales or omnichannel customer engagement experience preferred., • Strong understanding of ophthalmology practices, retina centers, academic medical centers, referral networks, and the ophthalmology market landscape., • Knowledge of inherited retinal diseases, ophthalmology treatment pathways, and patient identification processes preferred., • Demonstrated ability to develop, execute, and manage strategic account plans in a virtual environment., • Proven success in developing customer relationships and influencing treatment adoption through remote engagement channels. PREFERRED QUALIFICATIONS: • Existing relationships with ophthalmologists, retina specialists, IRD specialists, genetic counselors, and key opinion leaders (KOLs) are highly valued., • Experience supporting therapies that require genetic testing or specialty patient identification processes preferred., • Rare disease launch experience preferred., • Virtual pharmaceutical sales, inside sales, customer success, tele-sales, or omnichannel engagement experience preferred., • Demonstrated success utilizing digital engagement strategies to drive customer adoption and business performance. Additional Information Patient Minded - I act with the patient’s best interest in mind. Client Delight - I own every client experience and its impact on results. Take Action - I am empowered and hold myself accountable. Grow Talent - I own my development and invest in the development of others. Win Together - I passionately connect with anyone, anywhere, anytime to achieve results. Communication Matters - I speak up to create transparent, thoughtful and timely dialogue. Embrace Diversity - I create an environment of awareness and respect.. Our team is aware of recent fraudulent job offers in the market, misrepresenting EVERSANA. Recruitment fraud is a sophisticated scam commonly perpetrated through online services using fake websites, unsolicited e-mails, or even text messages claiming to be a legitimate company. Some of these scams request personal information and even payment for training or job application fees. Please know EVERSANA would never require personal information nor payment of any kind during the employment process. We respect the personal rights of all candidates looking to explore careers at EVERSANA. EVERSANA is committed to providing competitive salaries and benefits for all employees. If this job posting includes a base salary range, it represents the low and high end of the salary range for this position and is not applicable to locations outside of the U.S. Compensation will be determined based on relevant experience, other job-related qualifications/skills, and geographic location (to account for comparative cost of living). This role is eligible for hire in select U.S. locations based on business and operational considerations. For a full list of locations, visit eversana.com/careers. More information about EVERSANA’s benefits package can be found at eversana.com/careers. EVERSANA reserves the right to modify this base salary range and benefits at any time. From EVERSANA’s inception, Diversity, Equity & Inclusion have always been key to our success. We are an Equal Opportunity Employer, and our employees are people with different strengths, experiences, and backgrounds who share a passion for improving the lives of patients and leading innovation within the healthcare industry. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All of our employees’ points of view are key to our success, and inclusion is everyone's responsibility. Consistent with the Americans with Disabilities Act (ADA) and applicable state and local laws, it is the policy of EVERSANA to provide reasonable accommodation when requested by a qualified applicant or candidate with a disability, unless such accommodation would cause an undue hardship for EVERSANA. The policy regarding requests for reasonable accommodations applies to all aspects of the hiring process. If reasonable accommodation is needed to participate in the interview and hiring process, please contact us at applicantsupport@eversana.com. Follow us on LinkedIn | Twitter

Job Description Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is an award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work® Certified organization, recognized for our exceptional culture and industry-leading employee retention. We support the pharmaceutical, biotech, and medical device industries with our proven scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join MMS and be part of a team that is shaping the future of clinical research. Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn. Core Responsibilities • Lead the planning and preparation of IND, NDA, and MAA submissions to applicable regulatory authorities in partnership with functional leads., • Partner with cross-functional clinical, biometrics, regulatory writing, regulatory affairs, and regulatory operations teams to identify dependencies, mitigate risks, and adjust operational strategies to meet submission deadlines., • Develop and maintain detailed submission timelines, including dependencies, critical paths, resource needs, and contingency plans for critical tasks., • Oversee multiple client engagements and concurrent deliverables, prioritizing a high-volume, complex workload to meet submission deadlines., • Lead project discussions, build team consensus, track progress, and provide clear project metrics and status, risk, and performance updates to key stakeholders., • Manage project budgets, revenue recognition, timely invoicing, profitability, margins and utilization., • Contribute to RFP scoping and costing efforts and clearly communicate the company’s value proposition in written and verbal business development discussions., • Partner with clients to understand their needs, evaluate options, and recommend practical business solutions., • Identify opportunities to improve customer satisfaction and strengthen long-term client relationships., • Facilitate effective meetings with remote and global teams, communicate changes clearly, negotiate constructively, resolve conflicts, and promote efficient collaboration., • Support continuous improvement by identifying opportunities to enhance project processes, collaboration, and outcomes., • Promote open communication and effective collaboration across remote and global teams. Requirements • Bachelor’s degree or equivalent relevant experience, with at least 5 years of project coordination, project management, or related experience., • Expert knowledge of pharmaceutical development phases and NDA structure; NDA and MAA filing experience strongly preferred., • Demonstrated experience developing and managing integrated regulatory submission plans, including timelines, dependencies, critical paths, risks, resource needs, and contingency plans., • Strong organizational, communication, collaboration, and problem-solving skills, with the ability to understand stakeholder needs and develop practical solutions., • Experience managing project budgets, invoicing, profitability, margins, and utilization, with the ability to analyze financial performance and take appropriate action., • Demonstrated ability to manage multiple client engagements and concurrent deliverables while prioritizing a high-volume, complex workload., • Demonstrated experience leading client-facing discussions and collaborating effectively with remote, global, and cross-functional teams., • Working knowledge of CRO operations and the drug development process. Powered by JazzHR naOIVv9DXu

Job DescriptionCompany Description At Sobi, we believe diversity drives innovation and inclusion creates stronger teams. We are committed to building a workplace where everyone feels valued and empowered to contribute. If this role excites you but you’re unsure if you meet every requirement, we encourage you to apply. Your unique perspective and experiences could be exactly what we need. We look forward to hearing from you! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: • Competitive compensation for your work, • Generous time off policy, • Opportunity to broaden your horizons by attending popular conferences, • Emphasis on work/life balance, • Collaborative and team-oriented environment, • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatmentsJob Description Sobi is hiring for 3 Sr MSL, Lymphoma (Lacutamab) openings. Candidates can work remotely anywhere in the continental U.S., with a strong preference that they're located within 30-40 minutes of a major airport. As the Senior Medical Science Liaison (MSL), Lymphoma (Lacutamab), you will serve as a field-based scientific expert on cutaneous T-cell lymphoma (CTCL) and lacutamab, a humanized monoclonal antibody immunotherapy targeting KIR3DL2. You will build trusted scientific relationships, exchange balanced medical information, and generate actionable insights that inform US Medical Affairs strategy and launch readiness. You will support Sobi's rare disease portfolio in the hematology franchise and serve as a trusted scientific resource across the hematology-oncology, dermatology, and dermato-oncology communities. You will collaborate with academic, community, and multidisciplinary care teams, always in accordance with regulatory, legal, and compliance requirements. This is a field execution role within Hematology Medical Affairs. You will contribute insights and a field perspective to the CTCL medical strategy, which is led by Medical Affairs leadership. What You Will Do Scientific Engagement and External Relationships • Serve as a primary field-based scientific point of contact for Sobi Medical Affairs within your assigned geography., • Develop and maintain meaningful, two-way relationships with opinion leaders, healthcare professionals, medical organizations, investigators, and other stakeholders involved in CTCL care., • Exchange accurate, fair, balanced, and scientifically rigorous information on CTCL, lacutamab, relevant clinical data, disease biology, treatment approaches, and the evolving care landscape., • Engage across academic, community, and multidisciplinary settings, including hematology-oncology, dermatology, and dermato-oncology practices., • Respond appropriately to unsolicited scientific inquiries and connect stakeholders with Sobi resources in line with applicable policies and procedures. Medical Insights and Strategy Execution • Identify, document, and share high-quality field insights on unmet needs, clinical practice, patient pathways, evidence gaps, stakeholder perspectives, competitive developments, and the treatment landscape., • Partner with Medical Affairs leadership and cross-functional colleagues to interpret insights and inform adjustments to medical strategy, tactics, educational priorities, and engagement plans., • Execute territory-level medical plans aligned with the US CTCL and lacutamab medical strategy, adapting engagement to local and regional stakeholder needs., • Support key institution and stakeholder engagement planning, helping establish Sobi as a trusted scientific partner in CTCL. Launch Readiness, Education, and Congress Support • Contribute to lacutamab launch preparedness through disease-state education, articulation of unmet need, scientific exchange, stakeholder mapping, and field execution of approved medical tactics., • Provide internal and external scientific training on CTCL disease biology, preclinical science, clinical data, evidence gaps, and relevant outcomes., • Participate in or support advisory boards, medical roundtables, webinars, symposia, and other educational activities at local, regional, and national levels., • Represent Sobi Medical Affairs at scientific and medical congresses, and synthesize and communicate key updates and implications to internal stakeholders., • Collaborate to identify and develop field resources and scientific materials specific to CTCL and lacutamab. Evidence Generation and Clinical Development Support • Provide field-based support to Clinical Development and Clinical Operations, including site identification and recommendations, investigator engagement, communication facilitation, site initiation support, and patient accrual support., • Identify evidence gaps and potential research opportunities, and communicate them to appropriate internal partners., • Contribute scientific and field perspectives to evidence generation activities, real-world evidence initiatives, publications, and medical education programs, as appropriate., • Support investigator-sponsored research and other research collaborations in accordance with company processes and governance. Cross-Functional Collaboration and Territory Leadership • Partner with colleagues in Medical Affairs, Medical Information, Clinical Development, Market Access, Patient Advocacy, Commercial, Legal, Compliance, and other functions, while maintaining the independence and integrity of the Medical Affairs role., • Serve as a scientific resource to internal stakeholders and contribute to cross-functional initiatives consistent with Medical Affairs objectives and company guidelines., • Demonstrate excellence in territory planning, stakeholder prioritization, documentation, follow-through, and management of multiple projects and competing priorities., • Contribute to the broader Field Medical organization's success by sharing best practices, supporting colleagues, and fostering a collaborative, respectful, patient-focused culture. What Success Looks Like Success in this role is marked by: • Scientific credibility and curiosity, • Strategic territory leadership, • Insight generation and synthesis, • Trusted stakeholder partnership, • Cross-functional collaboration, • Clear, balanced communication, • Agility and a solution-oriented approach, • Operational excellence, • A patient-centered mindsetQualifications Required and Preferred Qualifications • Education: Accredited doctorate degree in a life-science, health-science, or basic-science discipline, such as PharmD, PhD, DNP, DSc, MD, or DO., • Candidates with another advanced health degree and extensive relevant industry or clinical experience may be considered., • Experience: At least 5 years of MSL experience in hematology/oncology, heme-onc, or a closely related therapeutic area is required., • Further experience in the following is highly valued:, • Clinical practice, Cutaneous T-cell lymphoma (CTCL), Peripheral T-cell lymphoma (PTCL), lymphoma, dermatology, dermato-oncology., • Rare disease and/or product launch., • Scientific acumen: Strong ability to understand, critically evaluate, and clearly communicate complex scientific and clinical information., • Clinical hematology-oncology background is highly preferred., • Knowledge of CTCL and/or PTCL and the multidisciplinary care environment is an advantage., • Patient focus: Strong commitment to patient needs and advancing scientific understanding within the CTCL community. Location, Travel, and Work Environment • Remote, field-based position supporting an assigned US geography., • Frequent domestic travel by ground and/or air is required (60% or more), depending on territory size, stakeholder needs, congress participation, and business requirements., • Ability to attend local, regional, and national meetings, including occasional evening or weekend programs, as business needs require., • Ability to work effectively from a remote office and manage a geographically dispersed territory. Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: • A competitive 401(k) match to support your financial future., • Tuition and wellness reimbursements to invest in your personal and professional growth., • A comprehensive medical, dental, and vision package to prioritize your health and well-being., • Additional recognition awards to celebrate your achievements. The base salary range for this role is $215,000 - $230,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to jennifer.partyka@sobi.com. Know Your Rights

Job Description About Opus Regulatory: Founded in 1994, Opus Regulatory (Opus) is a specialist consultancy providing experts in Regulatory Strategy, CMC, Labeling, and Ad Promo. Our clients range from development-stage biotech companies to mid-size and large pharmaceutical organizations. Our team is made up of biopharmaceutical leaders and innovators. Our mission is to provide the highest-level of Regulatory Affairs consulting service in the industry and to continually exceed the expectations of our clients. Multiple Openings | Associate Director–VP Experience Levels Opus Regulatory's Advertising & Promotional Strategy (Ad Promo) Practice is hiring Principal Consultants to support life sciences clients across a variety of projects, products, and therapeutic areas. In this role, you will combine strategic regulatory guidance with hands-on execution, helping clients navigate advertising and promotional requirements throughout product development, launch, and commercialization. As an embedded member of client teams, you will lead regulatory review, advise cross-functional stakeholders, and build strong relationships with client leadership and regulatory authorities, as appropriate. We welcome candidates with experience at the Associate Director through Vice President levels who enjoy solving complex regulatory challenges and contributing directly to client success. Key Responsibilities Serve as a regulatory advertising and promotion expert within client teams, advising on strategy, requirements, processes, submissions, and best practices. Provide strategic and operational leadership for promotional, educational, and investigational product communications. Review advertising, promotional materials, and other communications for compliance with applicable laws, regulations, guidance, and client policies. Partner with cross-functional stakeholders to develop clear, actionable recommendations that support business objectives and regulatory compliance. Lead regulatory planning and review of promotional materials for product launches and ongoing commercialization. Apply knowledge of U.S. and relevant international regulatory requirements to development programs and marketed products. Monitor evolving regulatory requirements and advise client teams on their implications for communications, materials, and strategy. Represent regulatory affairs in client meetings and workstreams, manage project priorities, and support related regulatory initiatives. Qualifications 6+ years of pharmaceutical regulatory affairs experience specializing in advertising and promotional strategy. Bachelor's degree required; an advanced degree in a scientific discipline preferred. Demonstrated ability to provide both strategic counsel and hands-on regulatory support for advertising and promotional activities. Global or international regulatory experience required; experience across multiple therapeutic areas highly desirable. Strong project management skills, including the ability to coordinate regulatory deliverables, submissions, and competing priorities. Strong communication and collaboration skills, with the ability to build trusted relationships and translate complex requirements into practical guidance. Ability to work independently, exercise sound judgment, and develop creative solutions to regulatory and operational challenges. At Opus Regulatory, we are committed to pay transparency and equitable compensation practices. Actual compensation will be determined based on factors such as experience, education, specialized expertise, geographic location, and internal equity. In select circumstances, compensation may fall outside of the posted range. US-Remote Pay Range $230,000—$300,000 USD Opus Regulatory is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. Opus is committed to providing benefit-eligible employees with a comprehensive benefits package designed to support your health, financial well-being, and work-life balance. We offer medical, dental, vision, and prescription drug coverage for employees and their eligible family members. Additional benefits include Life Insurance, Short-Term Disability (STD), and an Employee Assistance Program (EAP), a 401(k) plan, and more. To support time away from work, we provide a paid time off package, which includes 20 vacation days, 5 sick days, & 10 paid company holidays annually.

Job Description Hi, we're Oscar. We're hiring a Market Medical Officer, Atlantic to join our Clinical Affairs team. Oscar is the first health insurance company built around a full stack technology platform and a relentless focus on serving our members. We started Oscar in 2012 to create the kind of health insurance company we would want for ourselves—one that behaves like a doctor in the family. About the role: The Market Medical Officer is the clinical executive for the Atlantic region, partnering with P&L leadership to lead market performance, expand care access, and enhance affordability. You will optimize medical cost trends and reimbursement strategies to balance financial sustainability with plan performance. As the primary clinical liaison, the Market Medical Officer executes regional programs while seamlessly bridging corporate operations with local provider leadership. You will report into our Vice President, Clinical Affairs. Work Location: This position is fully remote and open to candidates residing in Georgia, North Carolina, South Carolina, New Jersey, New York, Pennsylvania, or Virginia. Daily work is completed from your home office, with occasional travel required for team meetings and company events. #LI-Remote Pay Transparency: The base pay for this role in the states of California, Connecticut, New Jersey, New York, and Washington is: $290,628- $381,449 per year. The base pay for this role in all other locations is: $261,565 - $343,304 per year. You are also eligible for employee benefits, participation in Oscar's unlimited vacation program, company equity grants and annual performance bonuses. Responsibilities: • Drive performance of key clinical metrics for trend management and market performance of plans in their region including but not limited to ED/K, APK, ALOS and others in partnership with market P&L leadership., • Work in partnership with Med Econ to identify market based utilization trends and flares and develop solutions to address key drivers to reduce overall spend., • Build strategic partnerships with health systems, physician groups, and community providers to align incentives and lower the total cost of care., • Serve as regional clinical partner across internal teams, partnering closely with Affordability, Utilization Management (UM), Care Management (CM), Claims, and others to drive regional performance goals., • Partner with Network Contracting leadership to guide clinical initiatives that enhance provider alignment, care quality, and clinical outcomes across the region., • Proactively identify and resolve regional network gaps and access barriers to advance equitable, high-quality care across all member populations., • Collaborate with regulatory agencies and compliance teams to ensure regional network adequacy and quality programs comply with state and federal requirements, translating policy changes into proactive operational strategy that protect member access and organizational performance., • Serve as the point of accountability for regional escalations, including internal/external appeals, provider and member grievances, and complex case management scenarios., • Compliance with all applicable laws and regulations., • Other responsibilities as assigned. Requirements: • 12+ years of progressive leadership experience in healthcare., • 10+ years of experience in managed care with prior experience leading in a matrix environment., • 7+ years of experience of clinical leadership in role specific market., • 7+ years of experience managing clinical market trend in health insurance or full risk bearing clinical provider groups., • 5+ years of clinical practice and board certified in one of the following fields: internal medicine, family medicine, general surgery, emergency medicine (other fields will be considered)., • 5+ years of experience leading teams. Education: • MD or DO with a current unrestricted license to practice medicine is required in a state in the region (GA, NC, SC, NJ, NY, PA, VA) License and Certification: • Reviewers must maintain necessary credentials to retain the position including maintaining active board certification., • Willing and able to obtain additional state licensure (with Oscar's support). Bonus points: • P&L experience for risk bearing entity., • Licensure in multiple Oscar states., • Masters degree or advanced certificate., • Prior experience with Utilization management. This is an authentic Oscar Health job opportunity. At Oscar, being an Equal Opportunity Employer means more than upholding discrimination-free hiring practices. It means that we cultivate an environment where people can be their most authentic selves and find both belonging and support. We're on a mission to change health care -- an experience made whole by our unique backgrounds and perspectives. Pay Transparency: Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience. Full-time employees are eligible for benefits including: medical, dental, and vision benefits, 11 paid holidays, paid sick time, paid parental leave, 401(k) plan participation, life and disability insurance, and paid wellness time and reimbursements. Artificial Intelligence (AI): Our AI Guidelines outline the acceptable use of artificial intelligence for candidates and detail how we use AI to support our recruiting efforts. Reasonable Accommodation: Oscar applicants are considered solely based on their qualifications, without regard to applicant's disability or need for accommodation. Any Oscar applicant who requires reasonable accommodations during the application process should contact the Oscar Benefits Team (accommodations@hioscar.com) to make the need for an accommodation known. California Residents: For information about our collection, use, and disclosure of applicants' personal information as well as applicants' rights over their personal information, please see our Privacy Policy.

Job Description Company introduction: Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to unlocking urgently needed new treatment options in mental health care. The Company is headquartered in London, UK, with a U.S. office in New Jersey. We believe mental health patients deserve the possibility of a better future. Our initial focus is developing COMP360 psilocybin, a proprietary, investigational, synthetic psilocybin treatment under evaluation for treatment-resistant depression (TRD) and post-traumatic stress disorder (PTSD). COMP360 is a potentially first-in-class treatment and has Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA), as well as Innovative Licensing and Access Pathway (ILAP) designation in the UK for TRD. We are leading the world's largest classic psychedelic clinical program in TRD, and building upon that robust foundation, we are executing a late-stage trial evaluating COMP360 for PTSD, another condition with high unmet need. Our goal is to advance treatments that move the field of psychiatry towards treatment options that offer rapid onset and sustained durability with infrequent dosing. - Compass Pathways Job overview: The field-based Health Economics & Outcomes Research (HEOR) Science Liaison is a scientifically trained, field-based expert, that serves as the interface between the company and external healthcare decision makers (HCDMs), including managed care organizations, pharmacy benefit managers, and other health technology assessment bodies. The HEOR Science Liaison delivers credible, non-promotional scientific information across clinical evidence, real-world evidence (RWE), pharmacoeconomic information, and health outcomes to support informed formulary, coverage, and reimbursement decisions. The role spans the full product lifecycle and is key to demonstrating the value of innovative therapies to payer and access stakeholders. Location: Remote in the United States. Reports to: Director, HEOR. Roles and responsibilities (Include but are not limited to): External Scientific Engagement • Identify, cultivate, and maintain peer-to-peer relationships with key payer thought leaders, medical/pharmacy directors, formulary decision makers, Chief Medical Officers, Chief Pharmacy Officers, and other HCDMs within assigned geography, • Deliver fair-balanced, scientifically rigorous presentations on clinical trial data, real-world evidence, pharmacoeconomic models, and patient-reported outcomes (PROs), • Respond to unsolicited medical information requests from payer and access stakeholders with accurate, compliant, and timely scientific content, • Attend and represent the organization at managed care, payer, and scientific conferences to maintain awareness of current landscape issues and emerging data HEOR Evidence Generation & Dissemination • Partner with internal HEOR, RWE, and Medical Affairs teams to identify evidence gaps and support the design, execution, and dissemination of field-based observational studies, retrospective analyses, and pharmacoeconomic research, • Facilitate investigator-initiated and collaborator-initiated research proposals; coordinate with appropriate internal stakeholders for review and approval, • Support development and communication of health economic models, cost-effectiveness analyses, and budget impact tools for payer audiences, • Contribute to publications, posters, and abstracts for scientific meetings and peer-reviewed journals Payer Landscape Intelligence & Insights • Gather and synthesize field intelligence on evolving payer policies, formulary decisions, coverage criteria, value-based contracting trends, and competitive landscape dynamics, • Communicate insights to internal stakeholders including Medical Affairs, Market Access, HEOR, and Commercial teams to inform strategy and evidence planning, • Monitor and interpret changes in managed care regulations, government payer policy (CMS, Medicare, Medicaid, VA/DoD), and HTA methodologies Cross-Functional Collaboration & Training • Serve as a scientific resource to Market Access Account Directors, Commercial teams, and other field-based colleagues; provide training on disease state, clinical data, and health economics topics, • Collaborate with Medical Science Liaisons (MSLs), Global Medical Affairs, and HEOR headquarters teams to align field activities with overarching medical strategy, • Appropriately collaborate with the Market Access team to educate and inform payers about clinical and health economic aspects of Compass Pathways' investigational and on-market products, • Participate in advisory board activities, scientific symposia, and payer-focused medical education programs, • Complete all required training, compliance reporting, and administrative responsibilities in accordance with corporate policy and applicable law, • Ensure all field activities comply with legal, regulatory, and industry (PhRMA/AMCP) guidelines, with particular attention to controlled-substance and REMS-related communication standards. Candidate Profile: • Advanced degree (M.D., D.O., Pharm.D. Ph.D.) or MPH/MS in a relevant scientific or health-related discipline (health economics, pharmacoeconomics, epidemiology, health services research, public health, or clinical sciences) required, • Minimum 8-12+ years pharma/biotech, including 5+ years in field HEOR, Value/Outcomes Liaison, or Market Access roles presenting to and engaging with payer customers, in collaboration with the Market Access function, • Demonstrated knowledge of health economics methodology, including cost-effectiveness analysis, budget impact modeling, QALYs, systematic reviews, and meta-analyses, • Strong understanding of the US payer landscape, formulary management, and reimbursement processes, • Proven ability to translate complex scientific and economic data into clear, compelling narratives for payer and access audiences, • Valid driver's license and ability to travel 50–70% of the time by car and air Compensation Description (annually): Our compensation package for permanent hires includes base salary, discretionary bonus, and equity, alongside our comprehensive benefits offering. Please note that the base salary range is a guideline, and individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location. 【Base salary per annum】: $235,000—$260,000 USD Benefits: For an overview of our benefits package and compensation information, please visit "Joins us - Our Benefits". These include flexibility & generous time off, parental & reproductive support, health & medical, mental health & wellbeing and Financial health. Equal opportunities: Reasonable accommodation We are committed to building a workplace where everyone's wellbeing matters. If you need reasonable accommodation during the interview process to be at your best, please let our recruiting team know. UK applicants We are proud of our commitment to diversity and equality (pursuant to the Equality Act 2010). We do not discriminate based upon race, religion or belief, colour, nationality, ethnic or national origin, gender, pregnancy or maternity, marital or civil partner status, sexual orientation, gender reassignment, age or disability. US applicants Compass Pathways is proud to be an equal opportunity employer. All employment decisions are based on business needs, job requirements, and individual qualifications, without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, and related medical conditions), ethnicity, age, disability, sexual orientation, gender identity, gender expression, military service, genetic information, familial or marital status, or any other status, category, or characteristic protected by applicable law. Sponsorship: Unfortunately, we cannot sponsor employment visas and can only accept applications if you have employment rights in the country to which you are applying. Data Privacy: All data is confidential and protected by all legal and data privacy requirements, please see our recruitment Privacy Notice to learn more about how we process personal data.

Director, Advocacy and Government Affairs (Federal Healthcare Policy) Location: Washington, DC (Remote within the Washington, DC metropolitan area, with occasional travel to the Academy's national office in Rosemont, IL.) Salary: $110,000.00 - $130,000.00 per year We are seeking a strategic and relationship-driven leader who is passionate about advancing healthcare policy and advocating for meaningful change. As Director, Advocacy and Government Affairs, you will serve as a trusted expert on legislative and regulatory issues affecting the specialty of Physical Medicine and Rehabilitation (PM&R), translating complex policy into thoughtful strategy and action. This is an opportunity to influence the future of the specialty by partnering with physician leaders, volunteers, policymakers, and national healthcare organizations to advance the Academy's advocacy priorities and strengthen its voice on Capitol Hill and beyond. About AAPM&R The American Academy of Physical Medicine and Rehabilitation (AAPM&R) is the national medical specialty organization representing more than 10,000 physicians who are specialists in physical medicine and rehabilitation (PM&R). PM&R physicians, also known as physiatrists, treat a wide variety of medical conditions affecting the brain, spinal cord, nerves, bones, joints, ligaments, muscles, and tendons. PM&R physicians evaluate and treat injuries, illnesses, and disability, and are experts in designing comprehensive, patient-centered treatment plans. Physiatrists utilize cutting-edge as well as time-tested treatments to maximize function and quality of life. What We're Looking For • Minimum of 5 years of government affairs, public policy, or advocacy experience within a healthcare-related organization., • Substantive federal legislative and regulatory experience, including direct engagement with Congress and/or federal agencies., • Experience working with physicians, medical specialty societies, or healthcare membership organizations strongly preferred., • Strong policy analysis and writing skills, including experience preparing legislative or regulatory materials, policy recommendations, and advocacy communications., • Demonstrated ability to build relationships with policymakers, healthcare stakeholders, organizational leaders, and volunteers. How to Apply Please visit our Careers Page (https://www.aapmr.org/about-aapm-r/careers-at-aapm-r) to review the full job description and submit your application. A resume and cover letter are required for consideration. AAPM&R is an equal opportunity employer Key Words: Government Affairs, Healthcare Policy, Health Policy, Legislative Affairs, Regulatory Affairs, Federal Affairs, Healthcare Advocacy, Government Relations, Public Policy, Federal Health Policy, Healthcare Legislation, CMS, Coalition Building, Stakeholder Engagement, Strategic Planning

Senior Spectrum Engineer, Regulatory Affairs, Remote (Preference for San Diego County, CA or Washington, DC), $180,000-$300,000 per year Are you a satellite regulatory expert with deep FCC licensing experience and strong knowledge of international spectrum policy? Our client, a leading global satellite communications and connectivity company, is seeking a senior technical leader to help secure and protect critical spectrum assets while influencing regulatory decisions on a global scale. This is a highly visible role combining advanced engineering analysis, FCC regulatory strategy, and international telecommunications coordination with organizations such as the ITU and key standards bodies. Who you are: • 10+ years of experience in satellite communications, spectrum management, regulatory affairs, or a related field, • Master's degree in Electrical Engineering, Science, Mathematics, or a related technical discipline, • Deep expertise in FCC licensing, FCC regulatory filings, market access, and satellite/Earth station licensing (required), • Strong knowledge of ITU Radio Regulations, international telecommunications policy, frequency coordination, and global satellite regulatory processes, • Must be authorized to work in the U.S. without sponsorship What you'll do: • Lead engineering analyses related to spectrum management, interference assessments, frequency sharing, and satellite regulatory matters, • Prepare and support FCC filings for satellite systems, Earth stations, licensing, and market access activities, • Represent the organization at international regulatory meetings and industry forums, including ITU, CITEL, 3GPP, and ETSI, • Lead frequency coordination discussions with satellite operators, administrations, and regulators worldwide, • Advise engineering, business, legal, and executive leadership on regulatory risks, opportunities, and spectrum strategy What does this position pay? Compensation is determined by several factors which may include skillset, experience level, and education. The expected range for this role is $180,000-$300,000 per year. Please note this range is an estimate and actual pay may vary based on qualifications and experience. What’s next? Please email your resume to if you’re excited to explore this opportunity with our client. We actively support and promote people of various backgrounds, from race, religion, gender to geographical area, university, lifestyle, and personality type. Proven Recruiting is minority-owned, majority women, and is a strong advocate for diversity and inclusion in the broader community. Apply today!

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a biotechnology research client in Basking Ridge, NJ No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Current Temporary Authorization Title: Senior Medical Analytics Consultant, Evidence Generation Location: Basking Ridge, NJ Remote (Mon-Fri, 40 hours) Contract Duration: 12 months, with likely extension Pay Rate: $60.00 - $75.00 per hour (w2) Position Overview We are seeking a Senior Medical Analytics Consultant to support Medical Affairs, R&D, and Evidence Generation initiatives. This individual will partner with global and regional stakeholders, technology teams, and evidence planning subject matter experts to develop analytical solutions that strengthen evidence planning, portfolio oversight, and strategic decision-making. The ideal candidate combines pharmaceutical or healthcare analytics experience with strong capabilities in analytical solution design, dashboard development, KPI measurement, data governance, and cross-functional collaboration. Key Responsibilities • Translate Medical Affairs, R&D, and evidence planning business needs into analytical requirements, data models, dashboards, and reporting solutions., • Lead cross-functional working sessions to define analytical objectives, data requirements, performance metrics, business rules, and data quality expectations., • Assess existing evidence planning dashboards and develop analytical frameworks that connect strategic priorities, evidence gaps, study concepts, ongoing studies, completed studies, and publications., • Define analytical specifications, KPIs, measurement frameworks, acceptance criteria, and data validation requirements for enterprise analytics solutions., • Partner with IT, technology implementation, and data teams to support enterprise data integration, data governance, metadata standards, and analytical data pipelines., • Analyze dashboard outputs to identify evidence gaps, overlaps, dependencies, trends, and opportunities to improve evidence planning and portfolio prioritization., • Develop measurement approaches to assess the impact of Medical Affairs and evidence generation activities, including leading and lagging indicators., • Evaluate opportunities to leverage AI and advanced analytics to improve evidence planning, analytical capabilities, and business decision-making., • Collaborate with Change Enablement teams to monitor adoption, evaluate analytical effectiveness, and identify opportunities for continuous improvement. Required Qualifications • Bachelor's degree in Data Analytics, Data Science, Business, Life Sciences, Public Health, Health Informatics, or a related discipline., • 6+ years of relevant experience in healthcare, pharmaceutical, biotechnology, clinical research, R&D, Medical Affairs, or analytics., • Experience translating business or evidence planning requirements into analytical solutions, dashboards, data products, or reporting capabilities., • Demonstrated experience designing or implementing dashboards and analytical solutions supporting portfolio planning, prioritization, and business decision-making., • Experience developing KPIs, performance metrics, measurement frameworks, and analytical reporting requirements., • Strong understanding of data interpretation, data quality, analytical validation, and documentation of business assumptions., • Experience collaborating with IT, technology implementation teams, data owners, and enterprise data platforms., • Understanding of data governance, regulatory compliance, privacy, and responsible data use within pharmaceutical or healthcare environments., • Strong project management, communication, and stakeholder management skills, with the ability to manage multiple priorities and deliverables across complex cross-functional initiatives. Preferred Qualifications • Experience in Evidence Generation, Integrated Evidence Planning, Medical Affairs, clinical development, research planning, publication planning, or study portfolio management., • Experience leveraging AI or advanced analytics to develop business solutions., • Experience working in agile, iterative, or product-oriented delivery environments., • Advanced degree such as a PhD, PharmD, or MD is strongly preferred. Work Arrangement This is a fully remote contract opportunity with occasional travel, up to 10%, primarily to Basking Ridge, New Jersey.

Research Engineer, Biological Safety and Orthopedic Devices Location: Remote, US-based Preferred location: Denver, CO, with onsite work possible for local candidates We are looking for a Research Engineer to support investigation, research, and remediation activities for orthopedic medical devices. This role will focus on biological evaluation, preclinical research, risk assessment, technical documentation, and regulatory support. The successful candidate will work closely with R&D, Design Engineering, Process Engineering, Manufacturing, Quality, Regulatory Affairs, Corporate, and site teams. Key responsibilities • Support the remediation and lifecycle management of existing orthopedic products., • Develop, review, and approve study protocols, technical reports, and biological safety documentation., • Lead or support biological safety risk assessments in accordance with ISO 10993., • Develop strategies for technical investigations and provide scientific expertise to cross-functional teams., • Coordinate laboratory studies, preclinical testing, timelines, deliverables, and external collaborators., • Support biocompatibility assessments and biological safety testing., • Contribute biological safety content and technical rationale for regulatory submissions., • Present scientific and technical information to internal stakeholders, regulatory bodies, surgeons, key opinion leaders, and external experts., • Prepare project updates, technical reviews, data presentations, and research summaries., • Support cross-functional project planning, risk management, scope, timelines, and execution. Required qualifications • Master’s degree in Biomedical Science, Biology, Toxicology, Materials Science, or a related discipline., • PhD or DVM is preferred., • 5+ years of experience in medical-device R&D with responsibility for biological safety risk assessment, or equivalent experience., • 3 to 5 years of hands-on preclinical in vivo research, including large-animal model testing., • Strong knowledge of ISO 10993, biocompatibility, biological evaluation, and orthopedic-device requirements., • Experience supporting regulated product development and cross-functional research programs., • Demonstrated project-management experience., • Strong scientific writing, presentation, problem-solving, and stakeholder-management skills., • Ability to communicate complex scientific and regulatory topics clearly to technical and non-technical audiences. This opportunity is ideal for someone with strong expertise in biological safety, orthopedic devices, preclinical research, and regulated medical-device development.

The Department of Physical Medicine and Rehabilitation is seeking a highly motivated Research Coordinator to be responsible for the day-to-day research operations of multiple research studies related to behavioral economics, rehabilitation, and stroke care innovation. The research coordinator assists with supporting and implementing research related activities including participant recruitment, data collection and management, communicating with various members of the research team, clinical staff, and participants, and assisting with Institutional Review Board filings and inquiries when needed. The research coordinator will be responsible for study coordination for investigator-initiated studies and patient-oriented clinical and translational research projects. This is a hybrid position, blending remote work with in-office collaboration each week. Job Responsibilities: Clinical Research Coordinator A • Assist in the management of clinical trials and cohort studies in the domain of stroke rehabilitation and behavioral economics. Additional responsibilities include implementing, refining, and carrying out protocols for multiple research studies, including data collection and management (including managing multiple electronic databases), maintaining the quality of intervention processes, maximizing retention of study participants and minimizing missing data, and assisting with data quality control checks., • Coordinate/assist with other research activities including review of medical charts, screening for eligibility, recruiting, supporting participant enrollment, and managing study-related materials., • Communicate with research investigators, patients, and patient support persons. Interact with clinical partners toward integrating studies into clinical care and revise research processes as needed to reflect pragmatic clinical practices., • Assist with preparation of regulatory documentation, support regulatory compliance by maintaining documentation, and prepare data for reporting and analysis. Qualifications: Bachelor's Degree with 1-2 years of related experience in research and clinical study methodologies or equivalent combination of education and experience is required. This position is contingent upon funding. Working Conditions Office, Library, Computer Room. Job Responsibilities: Clinical Research Coordinator B • Prepare and process all Institutional Review Board (IRB) submissions through the IRB and other regulatory groups as appropriate, including initial submissions, amendments, continuing reviews, adverse events, and serious adverse events, • Coordinate, organize, and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders), • Assist in the coordination of Phase I-IV clinical trials, • Participate in the conduct of study audits by sponsors, • Complete participant phone calls and engage with participants and their support person as needed., • Adhere to all University of Pennsylvania, ICF, and FDA guidelines., • Conduct initiation, monitoring, and closeout visits with sponsors and/or CROs, • Ensure proper screening and enrollment of all study participants, including confirming subject study eligibility before participation, • Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study-related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies, • Manage scheduling and coordination of participant health coaching sessions, • Meet with Principal Investigator routinely to discuss study-related issues and to ensure completion of study-related procedures (e.g., determination of causality for adverse events, deviation/exception requests), • Manage collection of data from multiple source documents, • Ensure preparation of study-related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start-up, • Ensure preparation of all required study-related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC), • Assist with protocol development to ensure logistical feasibility of all study-related procedures and study work-flow, • Other duties and responsibilities as assigned. Qualifications: Bachelor of Science and 2 to 4 years of experience or equivalent combination of education and experience is required. • This position is contingent upon grant funding., • Working Conditions Office, Library, Computer Room; Physical Effort Typically sitting at a desk or table Job Location - City, State Philadelphia, Pennsylvania Department / School Perelman School of Medicine Pay Range $47,313.00 - $55,294.00 Annual Rate Salary offers are made based on the candidate's qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job's level. Internal organization and peer data at Penn are also considered. Equal Opportunity Statement The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law. Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job. University Benefits • Health, Life, and Flexible Spending Accounts : Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family's health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars., • Tuition : Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions., • Retirement: Penn offers generous retirement plans to help you save for your future. Penn's Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard., • Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with familywhatever your personal needs may be., • Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you're newly hired, you won't have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting., • Wellness and Work-life Resources : Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That's why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance., • Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally., • University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University's libraries and athletic facilities, or visit our arboretum and art galleries. There's always something going on at Penn, whether it's a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you're right in the middle of the excitementand you and your family can enjoy many of these activities for free.

Bring your drive for excellence, teamwork, and customer commitment to Independence. Join us as we renew and reimagine the future of health care. Together we will achieve our mission to enhance the health and well-being of the people and communities we serve. Under the direction of the Senior Vice President Medical Management, the Vice President of Case and Condition Management Programs has broad discretion and accountability for the development and implementation of all internal and external case and condition management and population health programs focused on equitable whole-person care inclusive of both behavioral and physical health for members of Independence Blue Cross, AmeriHealth New Jersey and AmeriHealth Administrators (hereinafter collectively Independence) to improve access to well-coordinated, high quality, affordable care. The position collaborates on development and implementation with peers in Product, Marketing, Sales, Actuarial, Underwriting, Data, Analytics, and Informatics, Provider Reimbursement & Contracting, Medical Management, Health Value Optimization, Legal and others as required from time to time. These programs and services must comply with requirements of federal and State statutes and regulations and be approved where necessary by the applicable governing regulatory agencies. The position also collaborates with providers to create an integrated model that achieves best clinical outcomes for members with chronic conditions. The Vice President of Case and Condition Management Programs will need to be a thought leader working with business executives, to offer competitive programs across the healthcare continuum to engage members and providers to achieve better health outcomes and better cost management. Finally, this role will provide leadership that ensures programs implemented align with corporate strategy, meet business objectives, regulatory requirements, and offer exceptional internal and external member experience and satisfaction. Specific responsibilities include: • Provides the leadership in development of case and condition management and population health programs and services that align with the IHG strategy, vision, mission, and values., • Collaborates across the company ratings, Marketing, Sales, Provider Reimbursement & Contracting, Actuarial, Underwriting, Data, Analytics, and Informatics, Medical Management, Health Value Optimization, Legal, Government Markets and also with vendors and others as required from time to time to develop, implement, monitor and manage programs and services to meet emerging market demands and improve targeted clinical outcomes such as, HEDIS performance and CMS Stars ratings that align with clinical enhancement strategic initiatives., • Own strategic approach for case and condition management and population health management activities across IHG, vendors, and providers, determining best approach, ensuring coordination, and minimizing duplication while ensuring members are afforded a wide spectrum of asynchronous (e.g. computer based self-help and conversational AI and digital self-service), virtual (e.g. text, chat, telephonic, or audiovisual), and where possible integrated services across Independence, providers and vendors for both physical and behavioral health as well as health-related social needs., • Advances the responsible adoption of AI, advanced analytics, and intelligent automation by identifying innovative use cases and supporting implementation to improve operational efficiency, streamline workflows, enhance decision-making, and deliver high-quality, compliant, member-centered services., • Drives the delivery of case and condition management and population health programs and services that improve member experience, member outcomes, have positive financial return and provide value to customers including competitive performance guarantees., • Partners with providers in value based contracting arrangements to identify and implement case and condition management and population health programs and services that aim to promote integration and synergies to drive improved access, coordination, experience as well as quality and financial outcomes., • Oversee the management of the case and condition management associates and vendors to deliver programs and services that improve HEDIS performance, CMS Star ratings, including Medicare Part D medication adherence measures, and support providers in delivering clinical programs., • Oversee the integrated autism services model unit, aligning Customer Service, Utilization Management, Case Management, and Population Health associates to provide coordinated, responsive, person-centered, and family member-centered support., • Ensuring that all areas are meeting all objectives pertaining to quality, compliance, regulations, and productivity. In addition, provide exceptional experience for internal and external customers., • Proactively collaborates and partners with key functional areas to assess ongoing program activities, proposed program enhancements, and support initiatives designed to improve performance of key metrics associated with case and condition management and vendor programs., • Responsible for overseeing the relationships with population health vendors tasked with supporting the care journey for members with chronic conditions., • Provides clinical leadership input to contract negotiations, including the definition of service level agreements and the development and implementation of reimbursement strategies., • Provides advocacy and expertise to government affairs staff, legislators, and regulators on case and condition management and population health activities that address integrated, equitable whole-person care., • Oversee day-to-day operations of case and condition management and population health programs and services, including management of the budget, product implementation, and care management provider and vendor arrangements., • Partners with Sales in finalist meetings and other customer-facing engagements, representing Independence's case and condition management and population health capabilities, clinical strategy, differentiated value, and commitment to improved quality, outcomes, experience, and affordability., • Represent Independence externally to relevant organizations on key case and condition management matters, such as the BCBSA, Consortium National Accounts Clinical Leadership Roundtable, and AHIP., • Must possess current, active, applicable state license to practice. This license must not be subject to probation, proctoring requirements or other disciplinary action, in each state where the practitioner is licensed, and additional certifications where required, to practice his/her profession and specialty., • In good standing with Medicare, Medicaid and Federal DEA programs., • Professional experience of at least 3 years over a large clinical and non-clinical staff with increasing responsibility managing case and condition management related functions. Active unrestricted clinical License not subject to probation of proctoring requirements required., • Minimum of 10 years of progressive leadership roles in varied case and condition management operations., • Demonstrated track record as an effective collaborator using a consultative approach to influence others and gain consensus and then lead strategic projects to implement new case and condition management programs., • Sound knowledge of evaluation, deployment and management of case and condition management and vendor programs., • Demonstrated leadership skills in planning, measurement, monitoring and performance management with proven ability to develop and execute a business, including a strong track record of delivery success., • Strong leadership and talent management skills and effective verbal and written communication skills including presentation skills., • Demonstrable experiences in thinking beyond the current state and into the future, balancing multiple perspectives when setting direction or reaching conclusions., • Excellent interpersonal skills with internal and external customers. Experience in corporate budget, planning, and staff supervision preferred. Effective time management skills and the ability to multi-task in a fast-paced environment. Proficient computer skills. Hybrid Independence has implemented a "Hybrid" model which consists of Associates working in the office 3 days a week (Tuesday, Wednesday & Thursday) and remotely 2 days a week (Monday & Friday). This role is designated as a role that fits into the "Hybrid" model. While associates may work remotely on our designated remote days, the work must be performed in the Tri-State Area of Delaware, New Jersey or Pennsylvania. IBX is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to their age, race, color, religion, sex, national origin, sexual orientation, protected veteran status, or disability. Must have an Android or iOS device which is compatible with the free Microsoft Authenticator app.

At Transamerica, hard work, innovative thinking, and personal accountability are qualities we honor and reward. We understand the potential of leveraging the talents of a diverse workforce. We embrace an environment where employees enjoy a balance between their careers, families, communities, and personal interests. Ultimately, we appreciate the uniqueness of a company where talented professionals work collaboratively in a positive environment one focused on helping people look forward and plan for the best life possible while providing tools and solutions that make it easier to get there. Transamerica is organized into three distinct businesses. These include 1) World Financial Group, including Transamerica Financial Advisors, 2) Protection Solutions and Savings & Investments, comprised of life insurance, annuities, employee benefits, retirement plans, and Transamerica Investment Solutions, and 3) Financial Assets, which includes legacy blocks of long term care, universal life, and variable and fixed annuities. These are supported by Transamerica Corporate, which includes Finance, People and Places, General Counsel, Risk, Internal Audit, Strategy and Development, and Corporate Affairs, which covers Communications, Brand, and Government and Policy Affairs. Transamerica employs nearly 7,000 people. It's part of Aegon, an integrated, diversified, international financial services group serving approximately 23.9 million customers worldwide. As a key member of the Investment Compliance department, contribute to the design, implementation, and execution of an effective investment compliance program supporting the Office of the Chief Investment Officer (CIO) and the General Account. Mitigate legal, regulatory, operational, investment, and reputational risks through the application of compliance, insurance regulatory, and investment management knowledge. Perform complex assignments involving investment activities, portfolio oversight, regulatory change management, compliance monitoring, testing, and advisory support. Identify emerging regulatory and investment risks, communicate findings to senior management, support regulatory examinations and audits, and recommend practical enhancements that strengthen investment compliance controls, governance, and business practices. Responsibilities: • Own assigned investment compliance monitoring, surveillance, testing, regulatory change management initiatives, and compliance projects from planning through remediation. Develop and execute risk-based monitoring and testing programs designed to assess adherence to applicable investment guidelines, portfolio restrictions, regulatory requirements, and internal policies., • Perform reviews of investment activities, portfolio management practices, trading activity, investment operations, valuation processes, investment-related controls, policies, and procedures to assess adherence to applicable regulatory requirements, investment guidelines, and company standards., • Research, analyze, and interpret current, new, and proposed laws, regulations, accounting standards, regulatory guidance, and industry developments, including New York and Iowa insurance investment regulations, NAIC guidance, applicable state insurance requirements, and other applicable investment regulatory frameworks, to determine potential impact on General Account investment activities., • Identify emerging investment compliance risks, regulatory developments, control deficiencies, and governance gaps affecting fixed income, private assets, derivatives, structured products, alternative investments, securities lending programs, and other General Account investment activities. Recommend enhancements to controls, oversight processes, and governance frameworks., • Coordinate assigned aspects of regulatory examinations, state insurance department reviews, internal audits, external audits, risk assessments, inquiries, investigations, and other investment compliance-related reviews. Facilitate information requests, assess documentation, draft responses, track findings, and support remediation efforts., • Document testing procedures, results, compliance assessments, findings, recommendations, and corrective action plans. Track remediation activities and collaborate with CIO Office, Audit, Risk Management, Legal, Accounting, Valuation, Treasury, and Operations teams to ensure sustainable resolution of identified issues., • Draft, review, maintain, and enhance investment compliance policies, procedures, standards, monitoring reports, testing documentation, regulatory inventories, issue logs, investment guideline inventories, committee materials, and other governance documentation., • Serve as a trusted advisor to investment professionals and business partners by providing guidance regarding investment regulatory requirements, portfolio compliance obligations, investment guideline interpretation, control design, new investment strategies, and regulatory expectations., • Contribute to the development and enhancement of the investment compliance framework, including governance processes, compliance risk assessments, monitoring programs, surveillance capabilities, training initiatives, policies, procedures, and regulatory change management processes., • Represent Investment Compliance on committees, working groups, and strategic initiatives involving new asset classes, investment vehicles, derivatives, private investments, external managers, investment strategies, operational changes, technology implementations, regulatory developments, and control enhancements to ensure compliance requirements are appropriately considered and implemented., • Assist the Head of Investment Compliance in providing leadership and subject matter expertise on complex investment compliance matters. Mentor junior compliance professionals, promote knowledge sharing across the organization, and support the continued development of the GA investment compliance function. Qualifications: • Bachelor's degree in business, legal studies, risk management, compliance or related field, • 5+ years of regulatory compliance, insurance, securities, financial services, internal audit, risk management, testing, monitoring, and/or other relevant experience, • 2+ years of experience in insurance, registered investment adviser, retirement, investment, financial crimes, consumer affairs, regulatory change management, testing and monitoring, or other financial services compliance functions, • Experience working with business partners, Investments, Risk, Legal, Compliance, Operations, Sales, Marketing, product teams, or other stakeholders to support compliant business practices and process improvements, • Knowledge of applicable state insurance, NAIC, SEC, ERISA, DOL, IRS, AML, fraud, privacy, and/or other regulatory requirements based on assigned responsibilities, • Knowledge of regulatory compliance concepts, control testing, monitoring practices, policy and procedure review, issue identification, and remediation processes, • Ability to perform complex research, analyze, and interpret regulatory requirements, policies, procedures, data, and business processes to identify risks, issues, trends, and potential solutions, • Strong written and verbal communication skills, including the ability to summarize complex information clearly and communicate findings, recommendations, and regulatory expectations to varied audiences, • Analytical, critical-thinking, problem-solving, and organizational skills with strong attention to detail and accuracy, • Ability to manage multiple priorities, deadlines, reviews, requests, and projects with minimal supervision, • Proficiency using Microsoft Office tools Preferred Qualifications: • Experience using the Aladdin guideline monitoring system, • FINRA securities registrations, state insurance licenses, compliance certifications, or industry designations based on assigned responsibilities Compensation: The Salary for this position generally ranges between $85,000- $95,000 annually. Please note that the salary range is a good faith estimate for this position and actual starting pay is determined by several factors including qualifications, experience, geography, work location designation (in-office, hybrid, remote) and operational needs. Salary may vary above and below the stated amounts, as permitted by applicable law. Additionally, this position is typically eligible for an Annual Bonus based on the Company Bonus Plan/Individual Performance and is at the Company's discretion. Working Conditions: • This is a hybrid position requiring three days in office per week in one of our hub locations (Philadelphia or Cedar Rapids). Relocation assistance will not be provided for this position., • May require occasional travel for team meetings, training, regulatory matters, examinations, audits, governance meetings, industry forums, or business partner support. Applicants must possess legal authorization to work for our company in the U.S. without the need for immigration, sponsorship or otherwise serving as an employer of record for immigration employment purposes. At this time, this role is not eligible for immigration-related employment authorization sponsorship. Disclaimer: Beware of fake job offers! We've been alerted to scammers impersonating Transamerica recruiters, particularly for remote positions. Please note: • We will never request personal information such as ID or payment for equipment upfront., • Official offers are sent via DocuSign following a verbal offernot through text or email. What We Offer: For eligible employees, we offer a comprehensive benefits package designed to support both the personal and financial well-being of our employees. Compensation Benefits: • Competitive Pay, • Bonus for Eligible Employees Benefits Package: • Pension Plan, • 401k Match, • Employee Stock Purchase Plan, • Tuition Reimbursement, • Disability Insurance, • Medical Insurance, • Dental Insurance, • Vision Insurance, • Employee Discounts, • Career Training & Development Opportunities Health and Work/Life Balance Benefits:

Project Manager - Commercial Strategy 12 month contract Remote, EST Potential occasional visits to Princeton, NJ SUMMARY Our client, a pharmaceutical organization, has engaged GForce Life Sciences to provide a Project Manager. This position will support two commercial brand teams and oversee special projects across franchise and functional areas. The role involves managing brand planning, alliance governance, product Loss of Exclusivity (LoE), and national brand meetings, working within a heavily matrixed organization. DUTIES / EXPECTATIONS OF ROLE • Establish and facilitate team workflows and governance structures., • Manage project kickoffs and ongoing meeting cadences to ensure timely project completion., • Coordinate and facilitate workshops, capturing and delivering team status updates., • Develop and maintain project plans, milestone timelines, and team org charts., • Prepare and update team scorecards, KPIs, status reports, and communications plans., • Maintain meeting minutes, action items, and project documentation., • Collaborate with cross-functional teams including Brand Teams, Sales, Market Research, Medical Affairs, Market Access, Finance, Regulatory, Legal, and Promotional Compliance., • Coordinate with alliance partners to support project deliverables. MANDATORY REQUIREMENTS • Bachelor’s degree (BA/BS)., • 3-5 years of experience in the pharmaceutical industry, with marketing operations or marketing experience preferred., • Proven experience managing large, multi-workstream projects independently., • Knowledge of established project management methodologies, KPIs, and templates., • Ability to partner directly with brand teams and senior leadership., • Strong organizational, planning, and prioritization skills., • Excellent communication and interpersonal skills., • Proficiency with project management tools and Microsoft Office Suite., • Results-driven with a proactive, strategic leadership mindset., • Ability to function effectively in a fast-paced, ambiguous environment with competing demands. NICE TO HAVE • Experience managing brand Loss of Exclusivity (LoE)., • Knowledge of working across strategic alliances., • PMP certification.

Job DescriptionTitle: Care Management Coordinator/RN Location: 100% Remote Duration: 3+ Months (FT conversion) This is a Utilization Management RN part time position - working every other weekend (2 days a week in a 2 week cycle).*Must be available M-F 8:30-4:30pm for 2-3 weeks of training at start of assignment. Position is remote - candidate must reside in the tri-state area (PA, DE, NJ) Must have an active PA license or a Nurse Licensure Compact to include PA. Job Summary The Care Management Coordinator primary responsibility is to evaluate a member’s clinical condition through the review of medical records (including medical history and treatment records) to determine the medical necessity for patient’s services based on advanced knowledge and independent analysis of those medical records and application of appropriate medical necessity criteria. If necessary, the Care Management Coordinator directly interact with providers to obtain additional clinical information. The Care Management Coordinator has the authority to commit the company financially by independently authorizing services determined to be medically necessary based on their personal review. For those cases that do not meet established criteria, the Care Management Coordinator provides relevant information regarding members medical condition to the Medical Director for their further review and evaluation. The Care Management Coordinator has the authority to approve but cannot deny the care for patients. The Care Management Coordinator is also responsible for maintaining regulatory compliance with federal, state and accreditation regulations. Additionally, the Care Management Coordinator acts a patient advocate and a resource for members when accessing and navigating the health care system. Key Responsibilities Applies critical thinking and judgement skills based on advanced medical knowledge to cases utilizing specified resources and guidelines to make case determination. Utilizes resources such as; InterQual, Care Management Policy, Medical Policy and Electronic Desk References to determine the medical appropriateness of the proposed plan. Utilizes the medical criteria of InterQual and/or Medical Policy to establish the need for inpatient, continued stay and length of stay, procedures and ancillary services. Note: InterQual - It is the policy of the Medical Affairs Utilization Management (UM) Department to use InterQual (IQ) criteria for the case review process when required. IQ criteria are objective clinical statements that assist in determining the medical appropriateness of a proposed intervention which is a combination of evidence-based standards of care, current practices, and consensus from licensed specialists and/or primary care physicians. IQ criteria are used as a screening tool to support a clinical rationale for decision making. Contacts servicing providers regarding treatment plans/plan of care and clarifies medical need for services. Reviews treatment plans/plan of care with provider for requested services/procedures, inpatient admissions or continued stay, clarifying medical information with provider if needed. Identifies and refers cases in which the plan of care/services are not meeting established criteria to the Medical Director for further evaluation determination. Performs early identification of members to evaluate discharge planning needs. Collaborates with case management staff or physician to determine alternative setting at times and provide support to facilitate discharge to the most appropriate setting. Reports potential utilization issues or trends to designated manager and recommendations for improvement. Appropriately refers cases to the Quality Management Department and/or Care Management and Coordination Manager when indicated to include delays in care. Appropriately refers cases to Case and Disease Management. Ensures request is covered within the member’s benefit plan. Ensures utilization decisions are compliant with state, federal and accreditation regulations. Meets or exceeds regulatory turnaround time and departmental productivity goals when processing referral/authorization requests. Ensures that all key functions are documented via Care Management and Coordination Policy. Maintains the integrity of the system information by timely, accurate data entry. Performs additional duties assigned. Qualifications Education Active PA Licensed RN BSN Preferred Experience Minimum of three (3) years of Medical Surgical clinical experience in a hospital or other health care setting. Prior discharge planning and/or utilization management, InterQual or Millman/Robert’s experience is preferred. Medical management/precertification experience preferred. Knowledge, & Skills Exceptional communication, problem solving, and interpersonal skills. Action oriented with strong ability to set priorities and obtain results. Team Player - builds team spirit and interdepartmental rapport, using effective problem solving and motivational strategy. Open to change, comfortable with new ideas and methods; creates and acts on new opportunities; is flexible and adaptable. Embrace the diversity of our workforce and show respect for our colleagues internally and externally. Excellent organizational planning and prioritizing skills. Ability to effectively utilize time management. Oriented in current trends of medical practice. Proficiency utilizing Microsoft Word, Outlook, Excel, SharePoint, and Adobe programs. Ability to learn new systems as technology advances. Benefits: We offer a competitive compensation package that includes: • [Pay Rate]: $42 - $45 per Hour o Note: Pay rate will be commensurate with experience. • Medical for full time employees, • Dental, and Vision Insurance, • Life Insurance, Short-Term Disability, Long-Term Disability, etc.

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Call Center / Remote] - Anywhere in U.

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Call Center / Remote] - Anywhere in U.

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