Senior Manager, Medical Writing

This is a fully remote position, open to applicants in California.

📋 Description

• Create clinical and regulatory documents such as clinical study protocols and amendments, Investigator Brochures, lab manuals, annual reports (e.g., DSURs/IND annual reports), clinical study reports, and clinical sections of regulatory submissions (IMPDs, INDs, CTAs, and BLAs/MAAs as applicable).

• Write, edit, and collaborate with the clinical development team on various clinical and regulatory documents, ensuring scientific accuracy, internal consistency, and compliance with set standards.

• Facilitate efficient document management and maintain a consistent presentation style to uphold quality and ease of review across documents compiled in a regulatory dossier.

• Implement established standards and best practices for document review, completion, and approval processes; ensure compliance with regulatory requirements and guidelines, as applicable.

• Work alongside the team to develop and uphold medical writing standards, including document templates and style guides.

• Review and edit documents or sections of documents prepared by representatives from various functional areas, ensuring compliance with established standards.

• Compose and coordinate high-quality written responses to inquiries and deficiency letters from health authorities in collaboration with Regulatory Affairs and other cross-functional partners.

• Plan, write, edit, and review materials in conjunction with project teams, including conference abstracts, posters, oral presentations, and manuscripts, ensuring alignment with scientific strategies and corporate objectives.

• Manage and prioritize multiple project deadlines in a fast-paced environment; create and maintain timelines for assigned projects.

• Conduct quality reviews of documents in alignment with established standards and best practices, contributing to the overall quality of the medical writing program.

⛳️ Requirements

• A Bachelor’s degree is required; an advanced degree (MS, PhD, PharmD, or equivalent) in Biology, Chemistry, Biochemistry, or a related life science discipline is preferred.

• A minimum of four years’ experience in preparing clinical and regulatory documents within a life science organization, including experience in late-stage development (e.g., CSRs, BLA/MAA clinical sections).

• Experience in supporting cell therapy, gene therapy, or biologics programs is highly preferred.

• Proven ability to author and edit clinical-regulatory documents (e.g., protocols, IBs, CSRs, ICFs, briefing documents, and clinical sections of CTAs/INDs/IMPDs) with minimal supervision.

• Familiarity with ICH/GCP guidelines, FDA and EMA expectations for clinical-regulatory documents, and relevant editorial standards.

• Experience in facilitating health authority interactions, including the preparation of briefing documents and written responses to agency inquiries, is preferred.

• Excellent analytical, written, and editorial skills; ability to convey complex scientific concepts clearly and succinctly.

• Strong organizational skills and meticulous attention to detail; capable of managing multiple projects and competing deadlines in a fast-paced, dynamic environment.

• Ability to collaborate effectively with internal and outsourced teams and develop productive relationships with key cross-functional stakeholders, including Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, and Pharmacovigilance.

🏝️ Benefits

• Comprehensive benefits package, including Medical, Dental, and Vision coverage.

• Group Life Insurance.

• Long Term Disability (LTD) coverage.

• 401(k) Retirement Plan.

• Employee Assistance Program (EAP).

• Flexible Spending Account (FSA).

• Paid Time Off (PTO).

• Company-paid holidays, including a week off during the year-end holiday season.

• Our recognition program, Bonus.ly, allows you to exchange earned points for desired items.