Author the clinical, regulatory, and safety documents that carry a fast-growing oncology pipeline from the clinic to Health Authorities around the world.
Our client is a global biotechnology company focused on innovative antibody-based medicines, with a growing portfolio of approved oncology therapies and a broad late-stage clinical pipeline. Within its global drug safety and pharmacovigilance organization, the company is engaging a Senior Medical Writing Manager to serve as a lead writer across complex clinical, regulatory, and safety documents that support a demanding calendar of clinical trials and global regulatory submissions.
This is a senior lead-writer engagement. You will independently author and finalize high-stakes documents from template to approved version, partner closely with drug safety and pharmacovigilance scientists and physicians, serve as compound lead writer and the medical writing voice on cross-functional study and submission teams, and help shape the templates, standards, and processes that keep regulatory filings accurate and on time. Success in this role is defined by independent authorship, sound regulatory judgment, and the ability to keep complex reviews moving across many stakeholders.
***This is a full-time contract engagement (40 hours per week) running through mid-2027.
Essential Duties and Responsibilities
This list represents the major duties of the engagement and is not all-inclusive. The consultant may be asked to perform related duties beyond those described here.
Clinical and Regulatory Document Authoring
- Independently prepare, edit, and finalize complex clinical and regulatory documents, including clinical trial protocols and amendments, investigator's brochures, and clinical study reports.
- Author and contribute to clinical trial synopses, briefing documents, Pediatric Investigation Plans, and other clinical documentation that supports trial conduct and regulatory filings.
- Interpret complex clinical and scientific data and present it clearly, accurately, and consistently for regulatory and scientific audiences.
Safety and Aggregate Reporting Documents
- Author and contribute to aggregate safety reports, including Development Safety Update Reports (DSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs), in partnership with drug safety and pharmacovigilance colleagues.
- Draft and maintain safety content within clinical and regulatory documents, including investigator's brochure safety sections and reference safety information, Summaries of Clinical Safety, and safety-related Health Authority responses.
- Contribute to Risk Management Plans and other safety documentation supporting regulatory submissions and product lifecycle activities as needed.
Health Authority and Submission Documents
- Independently draft and edit Health Authority briefing books and responses to Health Authority questions.
- Prepare and review clinical overviews and clinical summaries in CTD/eCTD format for global regulatory submissions.
- Lead or participate in submission team activities, including document planning, cross-functional reviews, and resolution of complex reviewer comments.
- Draft and edit scientific publications as needed, including abstracts, posters, slide presentations, and manuscripts.
Cross-Functional Leadership and Document Management
- Serve as compound lead writer and represent Medical Writing on the Clinical Trial Team, protocol review committee, and regulatory submission teams.
- Provide guidance on document strategy, content, timelines, and resource needs to ensure timely completion with the desired quality.
- Manage documents end to end for a project or trial, from template through final approved version, including scheduling meetings, building timelines, and driving review decisions.
Process, Standards, and Knowledge Sharing
- Actively drive the development of templates and the establishment of medical writing processes and standards.
- Recommend and lead process improvement initiatives that strengthen cross-functional and global collaboration.
- Participate in inter- and intra-departmental knowledge sharing and lessons-learned sessions, and maintain current knowledge within relevant therapeutic and professional areas.
Regulatory and Quality Adherence
- Maintain up-to-date knowledge of ICH guidelines and applicable global regulatory requirements.
- Adhere to guidelines, SOPs, practices, and technical standards in all aspects of the work.
Qualifications
The requirements below are representative of the knowledge, skills, and abilities needed to perform this engagement successfully.
Required
- Bachelor's degree in a life science or related scientific discipline.
- 7+ years of medical writing experience within the pharmaceutical or biotechnology industry, including independently leading complex clinical and regulatory documents.
- Demonstrated experience authoring investigator's brochures, clinical summaries and overviews, briefing documents, and Health Authority responses.
- Strong knowledge of clinical development, regulatory submission requirements, CTD/eCTD structure, ICH guidelines, and applicable global regulatory requirements.
- Experience leading medical writing activities for regulatory submissions, including document planning, cross-functional reviews, timeline management, and resolution of complex reviewer comments.
- Proven ability to interpret and communicate complex clinical and scientific data clearly, accurately, and consistently.
- Strong project management, communication, and cross-functional collaboration skills, with the ability to represent Medical Writing on clinical development and regulatory teams and manage multiple priorities and timelines.
- Experience contributing to medical writing standards, templates, processes, and continuous improvement initiatives.
- Working knowledge of drug safety and pharmacovigilance principles and how safety data is presented in clinical and regulatory documents.
Preferred
- Advanced degree (PhD, PharmD, MD, or MS) in a scientific discipline.
- Experience authoring aggregate safety reports (DSURs, PBRERs, or PSURs) or Risk Management Plans.
- Experience partnering with drug safety physicians and scientists on safety and benefit-risk content.
- Oncology or hematology therapeutic-area experience.
- Experience authoring clinical protocols, clinical study reports, and Pediatric Investigation Plans.
- Experience as lead writer on a BLA, NDA, or MAA submission.
Nice to Have
- Experience with scientific publications, including abstracts, posters, and manuscripts.
- Familiarity with electronic document management and structured authoring tools (for example, Veeva Vault).
Engagement & Location
- Structure: Full-time contract engagement (40 hours per week).
- Location: Princeton, NJ area.
- In-Office Presence: 2 to 3 days per week.
Compensation: Hourly Rate: $90 to $102 per hour.
The rate offered will be commensurate with experience, skills, qualifications, and other relevant factors.
About the Search
This search is being managed by Summit Strategic Search on behalf of our client. This is a contract engagement supporting the client's drug safety and pharmacovigilance medical writing function.
Equal Opportunity Commitment: Summit Strategic Search and our client are equal opportunity partners. All qualified applicants will receive consideration for engagement without regard to race, religion, color, national origin, gender, gender identity or expression, sexual orientation, age, marital status, veteran status, or disability status.
Accommodations & Support: We are committed to providing reasonable accommodations for qualified individuals with disabilities during the application and interview process. If you require assistance, please contact us at admin@summitstrategicsearch.com. We maintain a zero-tolerance policy for harassment and provide all contractors with dedicated reporting channels to ensure a safe, professional work environment.
Selection & Onboarding: As this is a contract engagement within a regulated industry, the client's standard onboarding protocols apply. This includes, but is not limited to, a comprehensive background check and drug screening prior to the start of the engagement. All engagement decisions are made solely by the end client.