Senior Medical Writing Manager

Summit Strategic Search•Princeton, NJ

4d•Hybrid

About The Position

A global biotechnology company focused on antibody-based medicines is engaging a Senior Medical Writing Manager to lead medical writing within its drug safety and pharmacovigilance organization. The role supports oncology clinical trials and global regulatory submissions, with independent authorship and finalization of high-stakes clinical, regulatory, and safety documents from template through approved version. The writer will serve as compound lead writer and the Medical Writing representative on cross-functional study and submission teams, partnering closely with drug safety and pharmacovigilance scientists and physicians. The engagement is full-time, 40 hours per week, through mid-2027, in the Princeton, New Jersey area, with an in-office presence of two to three days per week. The role also helps shape document templates, standards, and processes; provides regulatory judgment; and keeps complex document reviews moving across stakeholders. Compensation is $90 to $102 per hour, commensurate with experience, skills, qualifications, and other relevant factors. Standard onboarding includes a comprehensive background check and drug screening before the engagement begins.

Requirements

Bachelor's degree in a life science or related scientific discipline.
At least 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.
Ability to interpret and communicate complex clinical and scientific data clearly, accurately, and consistently.
Strong project management, communication, and cross-functional collaboration skills, including 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.

Nice To Haves

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.
Experience with scientific publications, including abstracts, posters, and manuscripts.
Familiarity with electronic document management and structured authoring tools, such as Veeva Vault.

Responsibilities

Independently prepare, edit, and finalize complex clinical and regulatory documents, including clinical trial protocols and amendments, investigator's brochures, and clinical study reports.
Author or contribute to clinical trial synopses, briefing documents, Pediatric Investigation Plans, and other clinical documentation supporting trial conduct and regulatory filings.
Interpret complex clinical and scientific data and present it clearly, accurately, and consistently for regulatory and scientific audiences.
Author or contribute to aggregate safety reports, including DSURs and PBRERs, in partnership with drug safety and pharmacovigilance colleagues.
Draft and maintain safety content in clinical and regulatory documents, including investigator's brochure safety sections, 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.
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.
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 support timely, high-quality completion.
Manage documents end to end, from template through final approved version, including scheduling meetings, building timelines, and driving review decisions.
Drive development of templates and 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 in relevant therapeutic and professional areas.
Maintain up-to-date knowledge of ICH guidelines and applicable global regulatory requirements, and adhere to guidelines, SOPs, practices, and technical standards.