Director, Medical Writing Consultant

Summit Strategic Search•Princeton, NJ

9h•Hybrid

About The Position

The Director, Medical Writing will lead planning, project management, and scientific authoring of aggregate safety reports and other pharmacovigilance deliverables for a global biotechnology company focused on antibody-based medicines and oncology therapies. This senior-level contract engagement supports the client's global drug safety and pharmacovigilance organization. The role integrates and evaluates safety evidence, owns complex documents from strategy through finalization, serves as compound lead writer and medical writing representative on cross-functional teams, and leads submission teams of medical writers. Success requires strong scientific judgment, consistent safety messaging, and timely, high-quality, inspection-ready deliverables. The consultant will lead aggregate safety report planning and project management; author or oversee safety, clinical, and regulatory documents; assess and integrate evidence from clinical trials, spontaneous reports, literature, nonclinical studies, and other sources; and collaborate with Safety Physicians, Safety Scientists, Regulatory Affairs, Clinical Development, Biostatistics, and other experts. The position also supports medical writing strategy, team leadership, vendor oversight, process development, and continuous improvement of aggregate safety reporting practices. This is a full-time contract engagement of 40 hours per week for approximately six months. The anticipated start is early 2027, though an earlier start may be possible. The position is in the Princeton, New Jersey area, with in-office presence two to three days per week. Compensation is $120 to $140 per hour, commensurate with experience, skills, qualifications, and other relevant factors. Standard client onboarding includes a comprehensive background check. The search is managed by Summit Strategic Search on behalf of its client.

Requirements

Advanced degree in medicine, pharmacy, life sciences, or a related discipline, such as MD, PharmD, or PhD.
Strong foundation in clinical research, medical science, and safety data interpretation.
10 or more years of relevant experience in pharmacovigilance, clinical safety, regulatory medical writing, or a related pharmaceutical or biotechnology field.
Substantial experience independently authoring complex safety documents and leading cross-functional authoring for major submissions.
Demonstrated experience leading safety authoring for complex marketing authorization and post-approval submissions, including document strategy, scientific content, review, and timely delivery.
Proven ability to independently author and critically review key safety and regulatory deliverables, including DSURs, PSURs/PBRERs, PADERs/PAERs, Risk Management Plans, signal evaluations, Health Authority responses, Summaries of Clinical Safety, Clinical Overviews, Integrated Summaries of Safety, CSR safety sections, and patient narratives.
Expertise in integrated safety assessments and benefit-risk evaluations, synthesizing clinical trial, post-marketing, literature, and other evidence into scientifically sound conclusions and regulatory positions.
Experience translating safety findings into risk management measures, safety labeling, and Health Authority responses while maintaining consistent scientific messaging.
Strong understanding of global Health Authority expectations, CTD safety content, and pharmacovigilance requirements, with experience supporting regulatory submissions and Health Authority interactions.
Strong scientific judgment and ability to interpret complex clinical and safety data, identify material findings and evidence gaps, reconcile conflicting evidence, communicate uncertainty, and develop clear medical narratives and recommendations.
Ability to lead multiple concurrent deliverables and cross-functional reviews, manage dependencies and timelines, resolve content gaps, and maintain accuracy, traceability, consistency, and inspection readiness.
Excellent scientific writing, executive communication, and cross-functional leadership skills, including the ability to influence senior stakeholders and collaborate across Safety, Regulatory Affairs, Clinical Development, Biostatistics, and Medical Writing.
Experience developing authoring standards, templates, SOPs, training, and process improvements.

Nice To Haves

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

Responsibilities

Lead planning and project management for PSURs/PBRERs, DSURs, Risk Management Plan updates, and other pharmacovigilance deliverables, including reporting calendars, milestones, reviews, approvals, and submission readiness.
Identify risks, bottlenecks, content gaps, and conflicting reviewer feedback, and drive resolution while maintaining scientific coherence, traceability, quality, and inspection readiness.
Author complete aggregate safety reports or substantive sections, Risk Management Plans, 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, from evidence review and document strategy through finalization.
Prepare safety content for regulatory submissions, investigator's brochures, safety communications, governance materials, briefing documents, presentations, and responses to safety questions.
Propose document structure, key scientific messages, and evidence-based conclusions, and obtain appropriate medical and cross-functional alignment.
Integrate and critically evaluate clinical trial, spontaneous report, published literature, nonclinical, and other relevant evidence to characterize safety findings and assess clinical significance and implications for product safety profiles.
Develop evidence-based assessments of temporal relationships, alternative etiologies, confounding factors, class effects, risk factors, and data limitations; distinguish established findings from hypotheses and uncertainty.
Translate complex medical and scientific concepts into clear, accurate, and balanced narratives for intended audiences.
Perform scientific review and quality control for medical accuracy, data consistency, referencing, traceability, and compliance with regulatory requirements and internal standards.
Prepare, oversee, edit, finalize, and provide strategic direction for clinical and regulatory documents, including protocols and amendments, investigator's brochures, clinical study reports, Pediatric Investigation Plans, Health Authority briefing packages and responses, and clinical CTD submission documents.
Serve as compound lead writer and medical writing representative on cross-functional study teams, guiding document strategy, content, timelines, and resource needs.
Collaborate with Safety Physicians, Safety Scientists, Regulatory Affairs, Clinical Development, Biostatistics, and other experts to resolve scientific questions and align evidence, analyses, conclusions, and regulatory positions.
Support development and execution of medical writing strategy in line with organizational strategy.
Lead submission teams of medical writers, providing vision, coaching, and oversight of deliverables.
As required, oversee aspects of the medical writing portfolio, including maintaining the long-range forecast for medical writing needs.
Oversee medical writing activities and establish expectations and responsibilities with partners, CROs, and vendors.
Represent Medical Writing in project boards, global development teams, operational committees, partner steering committees, the clinical management team, the protocol review committee, and regulatory submission teams.
Own and maintain aggregate safety reporting and pharmacovigilance writing processes, including SOPs, templates, guidance documents, and training materials.
Identify and implement improvements in project management, evidence synthesis, and writing workflows to enhance efficiency, quality, consistency, and compliance.
Lead the development and review of standard processes and templates and drive knowledge-sharing sessions for cross-company initiatives.