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PRIMARY FUNCTION • Associate Director/Director plays a key role as clinical technical lead on global Phase I-III and other clinical pharmacology centric projects, • Serves as a team member supporting multiple facets of Clinical Pharmacology, including study design, PK and PK/PD analyses, and overall drug development support. This position is also the scientific and medical/clinical liaison between internal teams and external groups such as clinical operations, vendors (CROs, central laboratories, etc.), investigators, medical monitors, regulatory authorities, medical affairs, commercial, Key Opinion Leaders, Advisory Boards, • The candidate will have an excellent knowledge of Clinical Pharmacology principles, such as PK, PK/PD, drug metabolism, drug-drug interactions, PBPK, PopPK modeling and E-R analysis. Provides peer-reviewed interpretation of clinical pharmacology data and incorporates appropriate analyses into reports required for regulatory submissions MAJOR RESPONSIBILITIES AND DUTIES • Accountable and responsible for the Clinical Pharmacology support for the HUTCHMED global portfolio, • Provide scientific insights that drive global clinical development decisions and support global regulatory submissions, • Responsible for ensuring appropriate Clinical Pharmacology representation on drug/ dosage form development and clinical teams and provision of PK/PD expertise and leadership to a project, • The incumbent will complete assigned work in a resourceful, self-sufficient manner and will be able to create alternative approaches to achieve desired results if needed, • Responsible for ensuring planning and direction of Clinical Pharmacology components of clinical programs (including clinical development plan/life cycle plan) and studies (including synopsis and protocol preparation; clinical phase oversight, reporting), • Responsible for ensuring leadership of multifunctional study team to design, deliver and report the assigned clinical pharmacology studies and ensuring overall scientific accountability for the designated studies, • Responsible (with members of Clinicians and Statisticians) for ensuring appropriate dose-finding strategies during clinical drug development that will ensure optimal doses in first in human studies and dosage regimens in patients, • Responsible for summarizing and interpreting results of pharmacokinetic, pharmacodynamic analyses with respect to their impact on development and clinical use of drugs, • During the pre-clinical stages of drug development, works with Drug Discovery team to ensure that sufficient preclinical PK/PD knowledge exists to support progression into first in man studies, • Accountable for ensuring that there are valid methods for measuring drug and metabolite concentrations (or any biochemical biomarkers) in human studies, • Coordinates with medical writers (and other team members) in the data review, analysis and reporting of the Clinical Pharmacology study, • Responsible, in conjunction with medical writer, for overall content and accuracy of study report before forwarding for final sign-off. Assist with internal and external dissemination of results to Development Team, Investigators etc., • Provides recommendations for clinical doses and dosing algorithms (including drug interaction advice, food effects, special group dosing etc.) to the Clinical and Development teams and in regulatory documentation such as labeling, • Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource of clinical pharmacology and therapeutics knowledge in terms of both medical background and clinical trial design, • Participates in multidisciplinary teams in assessing potential in-licensing opportunities, as requested by line management, • Acts as technical lead for specific development projects, Phase I/III and Clinical Pharmacology centric studies, • Manage and initiate external collaborations with leaders in clinical pharmacology and Key Opinion Leaders MINIMUM REQUIREMENTS • PhD in clinical pharmacology, quantitative pharmacology, pharmacokinetics, or related field / MD/ PharmD preferred, • Biologics including monoclonal antibody, bispecific antibody, and antibody-drug conjugate experience is preferred, • Experiences in Oncology/Autoimmune disease field is preferred, • Proven expertise in pharmaceutical/biotech industry (8-15 years) with adequate knowledge in ICH guidelines, Good Clinical Practice applicable to Clinical Pharmacology, • Direct experience with clinical pharmacology summary documents required for Regulatory submissions, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization, • Experience in clinical development and new drug registration, • Mastery of statistics applied to clinical research, • Ability to work with pharmacometrician for PopPK modeling, E-R analysis, PBPK, and PK-PD modeling, and interpret the data to support the clinical development, • Good ability to interpret complex clinical data and experimental results, • Ability to develop network internally and externally to communicate in situations requiring special tact and diplomacy, • Self-motivated and self-disciplined individual with superb problem-solving and leadership skills, • Excellent English (writing and speaking) and excellent mastery of English medical terminology PREFERRED SKILLS AND EXPERIENCE: • Knowledge of FDA, EMA and ICH guidelines and regulations, • Record of successful publications in the area of clinical pharmacology/pharmacometrics, • Comprehensive understanding of worldwide clinical regulatory requirements with working knowledge of drug development process with a proven record in drug development from IND through regulatory submission and commercialization. Prior direct interaction with regulatory agencies and advisory boards is required, • Candidate must demonstrate thorough understanding of principles of clinical pharmacology including clinical study design, analysis, and interpretation, and application of these approaches to drug development, guidelines in the design of clinical trials and development plans KEY COMPETENCIES: • Ability to organize and work simultaneously on multiple projects, • Ability to work in a matrix, project-oriented environment, • Excellent written and oral communication skills, interpersonal/influencing skills, and ability to work in a continually changing environment, • Supports the success of a group being led by providing clarity, support and tools needed to excel as things change, • Maintains a functional, perspective and acts on the belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond the organization, • Actively builds relationships and networks with others across and beyond HUTCHMED working constructively across organizational boundaries despite differences in interests, perspectives and need

Job DescriptionWHY VITALIEF? Vitalief is emerging as an innovative Healthcare consulting company, focused on empowering Research and transforming Clinical Trials to further our mission and our clients’ mission to impact and save lives. As a result, we are seeking a talented and enthusiastic Senior level Senior Pre-Award Grants Writer for a variety of short-term (ad hoc, meaning could be either part-time or full-time hours) consulting engagements with Vitalief’s premier clients. Reasons to work for Vitalief: • You can actively contribute to our clients’ mission of advancing scientific discoveries that have the potential to change patients' lives for the better., • Our PEOPLE FIRST culture prioritizes personal and professional growth for all Vitalief employees. Work Location: Work is 100% Remote, though candidate must be local to EST/CST time zones. Responsibilities: • Working in close collaboration with our client’s Grants Team, help shepherd the pre-award process with established timelines and processes., • Identifies possible sources of funding, develops budgets in conjuncture with faculty and oversees submission., • Assists team in the preparation of proposals and grant applications, development of budgets and editing of documents and process proposals., • Prepares proposal strategies to maximize potential success in grant writing., • Communicates regularly with faculty to determine the status of current and pending submissions., • Represents the faculty in any negotiations with sponsors or other institutions., • 10+ years of experience of demonstrated related experience with emphasis on grant writing and program development preferably in a large academic institution., • Experience preparing Federal, NIH, and other research grant submissions from a regulations and requirements perspective., • Demonstrated experience building positive relationships and working effectively with PI’s, all levels within the client organization, as well as external grantor agencies and subcontracting institutions., • Expert knowledge in all aspects of pre-award research administration, submitting applications and working with eRA Commons., • Critical thinking & decision-making skills – ability to evaluate all aspects of a situation and to independently make appropriate and timely decisions., • Demonstrated proficiency in Microsoft Office, Word, Excel, PowerPoint and Adobe Acrobat applications., • Detail-oriented, excellent communication skills, ability to multi-task, prioritize to meet deadlines, problem-solve, and balance a sense of humor with necessity to interact professionally at all levels. #LI-DNP Powered by JazzHR sH1VYxnibr

Job Description Job Title: Investigation and Deviation Writer Job Description We are seeking a dedicated Investigation and Deviation Writer responsible for writing and completing investigations and deviations from a compliance and operations perspective. This role involves conducting root cause analyses and managing the full lifecycle of investigations, from initiation to closure, to ensure manufacturing and GMP compliance. Responsibilities • Determine the causes and preventative actions of Deviations, Non-Conformances, Out-of-Specification (OOS), Out-of-Trend (OOT), field complaints, and environmental excursion investigations., • Drive investigations to uncover true root causes using appropriate tools and benchmark industry standards., • Define and implement effective preventative actions to prevent recurrence., • Manage multiple investigations in different stages to efficiently meet compliance deadlines and product release dates., • Collaborate with cross-functional teams to develop and track Corrective and Preventative Action (CAPA) plans., • Identify and create appropriate trending rules that trigger corrective actions., • Analyze process data and evaluate trends to identify major improvement opportunities., • Utilize change management approaches effectively., • Develop training materials to educate personnel on writing problem statements and using root cause analysis tools., • Champion CAPA plans and implementation., • Provide ongoing communication plans for deviations and CAPAs., • Oversee timely completion of deviations, CAPAs, and Change Controls., • 2-3 years of experience writing and reviewing deviations and investigations within a pharmaceutical company., • Experience working with quality assurance teams to ensure accurate tracking and documentation of investigations., • Proficiency in root cause analysis, CAPA, and biologics., • Experience with GMP operations and/or Quality Assurance in Cell Therapies, Biotechnology, or Bio-Pharma., • Bachelor's degree in a related scientific field., • Experience in technical writing., • Experience with cell and gene therapies or biologics., • You will work closely with a team of QA/QC professionals in a collaborative environment, engaging cross-functionally with the manufacturing team., • The role involves working at two sites located close to each other., • The team consists of five other investigators, and you will work the first shift from Monday through Friday, starting between 8 AM and 9 AM. This is a Contract to Hire position based out of Allendale, NJ. Pay and Benefits The pay range for this position is $40.00 - $45.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision, • Critical Illness, Accident, and Hospital, • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, • Life Insurance (Voluntary Life & AD&D for the employee and dependents), • Short and long-term disability, • Health Spending Account (HSA), • Transportation benefits, • Employee Assistance Program, • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Allendale,NJ. Application Deadline This position is anticipated to close on Nov 27, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.