ASR Project Management and Pharmacovigilance Medical Writer - Hybrid

Aptask Global Workforce (AGW) is seeking a ASR Project Management and Pharmacovigilance Medical Writer for a Hybrid position with a Global Biotechnology Company located in Plainsboro, NJ. This is a 6+ month contract opportunity.

This role leads the planning, project management, and scientific authoring of aggregate safety reports and other pharmacovigilance deliverables. The ideal candidate will integrate and evaluate safety evidence to develop scientifically sound conclusions, ensure consistent safety messaging, and drive timely, high-quality, inspection-ready deliverables through cross-functional collaboration and continuous process improvement.

Responsibilities:

• Identify and implement improvements in project management, evidence synthesis, and medical writing workflows to enhance efficiency, quality, and compliance
• Author complete reports or substantive sections of aggregate safety reports, RMPs, signal evaluation reports, safety topic assessments, benefit–risk evaluations, health authority responses, and other safety-related regulatory documents
• Independently plan, develop, and author complex scientific and medical content across pharmacovigilance activities, taking ownership from initial evidence review and document strategy through finalization
• Integrate and critically evaluate evidence from clinical trials, spontaneous reports, published literature, nonclinical studies, and other relevant sources to characterize safety findings, assess clinical significance, and determine implications for the product safety profile
• Translate complex medical and scientific concepts into clear, accurate, and scientifically balanced narratives appropriate for the intended audience
• Develop evidence-based assessments addressing temporal relationships, alternative etiologies, confounding factors, class effects, risk factors, and data limitations
• Propose document structure, key scientific messages, and evidence-based conclusions, obtaining appropriate medical and cross-functional alignment
• Lead planning and project management for PSURs/PBRERs, DSURs, RMP updates, and other pharmacovigilance deliverables
• Proactively identify risks, bottlenecks, content gaps, and competing reviewer feedback, driving timely resolution
• Prepare safety content for regulatory submissions, investigator’s brochures, safety communications, governance materials, briefing documents, and presentations
• Collaborate with Safety Physicians, Safety Scientists, Regulatory Affairs, Clinical Development, Biostatistics, and other subject matter experts
• Perform scientific review and quality control to ensure medical accuracy, data consistency, and alignment with regulatory requirements
• Own and maintain aggregate safety reporting and pharmacovigilance writing processes, including SOPs, templates, and training materials

Requirements:

• Advanced degree in medicine, pharmacy, life sciences, or a related discipline (e.g., MD, PharmD, PhD)
• Minimum 10 years of relevant experience in pharmacovigilance, clinical safety, regulatory medical writing, or a related pharmaceutical/biotechnology field
• Demonstrated experience leading safety authoring for complex marketing authorization and post-approval submissions
• Proven ability to independently author and critically review key safety and regulatory deliverables, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, and signal evaluations
• Demonstrated expertise in integrated safety assessments and benefit–risk evaluations
• Experience translating safety findings into risk management measures, safety labeling, and health authority responses
• Strong understanding of global health authority expectations, CTD safety content, and pharmacovigilance requirements
• Strong scientific judgment and ability to interpret complex clinical and safety data
• Proven ability to lead multiple concurrent deliverables and cross-functional reviews
• Excellent scientific writing, executive communication, and cross-functional leadership skills
• Expertly prepare (or oversee the work of others), edit, finalize and contribute to the strategic direction of complex clinical and regulatory documents
• Support in development, implementation, and execution of Medical Writing strategy
• Serve as compound lead writer and medical writing representative on cross-functional study teams

Desired skills:

• Oncology development and submission experience preferred, including familiarity with complex treatment settings, combination therapies, and interpretation of safety findings in patients with advanced disease and significant comorbidities

Pay range: up to $140.85 per hour

Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.

If you have the described qualifications and are interested in this exciting opportunity, apply today!

Aptask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.

Benefits of working with ApTask Global Workforce include:

• Medical
• Dental
• Vision
• Sick Pay (for applicable states/municipalities)

Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. 

ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.