Senior Director, Medical Writing

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

📋 Description

• Oversee the medical writing strategy for designated development programs spanning all phases of product development.

• Act as the primary medical writing representative within cross-functional project teams.

• Create document plans, timelines, and resource strategies that align with regulatory milestones and corporate goals.

• Provide strategic insights on document content, messaging, regulatory positioning, and submission readiness.

• Ensure scientific messaging consistency across regulatory submissions and interactions with health authorities.

• Contribute to regulatory and development strategies by effectively communicating clinical and scientific data.

• Lead the planning, drafting, coordination, review, and finalization of clinical development documents, such as protocols, investigator brochures, CSRs, clinical development plans, statistical analysis plan summaries, clinical overviews, ISS, ISE, synopses, and executive summaries.

• Collaborate with regulatory leaders and subject matter experts to create INDs, CTAs, NDAs, BLAs, MAAs, supplements, briefing materials, Module 2 documents, orphan drug applications, expedited pathway applications, Pediatric Study Plans, and Pediatric Investigation Plans.

• Direct significant global submissions, rather than just individual documents within a major application.

• Ensure compliance of documents with ICH, GCP, CTD, and relevant regulatory guidance.

• Establish and uphold document standards, templates, style guides, and best practices.

• Guarantee quality control and consistency across documents and programs.

• Assist in inspection readiness and document audits.

• Keep abreast of evolving regulatory expectations and industry standards.

• Manage external medical writing vendors and consultants.

• Oversee outsourced writing activities, ensuring quality, adherence to timelines, and budget management.

• Review and approve deliverables generated by vendors.

• Aid in vendor selection and performance management.

• Mentor and develop internal medical writers as necessary.

• Contribute to departmental strategic planning and organizational growth.

• Lead process improvement initiatives and implement best practices.

• Engage in hiring, performance management, and talent development.

• Serve as a subject matter authority in medical writing and regulatory document development.

⛳️ Requirements

• A bachelor’s degree in life sciences, pharmacy, nursing, or a related field is required.

• At least 12 years of experience with a significant emphasis on medical writing in a biotechnology, pharmaceutical, CRO, or similar setting.

• Demonstrated experience and knowledge in leading and executing medical writing strategy in a dynamic biopharma environment or shown progression from large/medium pharmaceutical organizations to biotech.

• Willingness to travel for business 10–20% as needed.

• Previous experience managing medical writing teams and/or external vendors is preferred.

• Strong comprehension of drug development and combination product development.

• Expert knowledge of ICH guidelines, CTD structure, GCP requirements, and global regulatory expectations.

• Extensive expertise in preparing nonclinical, clinical, and regulatory documents.

• Familiarity with regulatory requirements across major health authorities, including FDA, EMA, PMDA, MHRA, Health Canada, NMPA, and ANVISA.

• Familiarity or experience with tools such as Veeva RIM, Starting Point templates, EndNote, and other technical resources.

• Ability to interpret and convey complex clinical, statistical, pharmacological, and scientific information effectively.

• Strong skills in data interpretation and synthesis.

• Excellent critical thinking and problem-solving capabilities.

• Proficient in identifying data gaps and formulating scientifically sound messaging strategies.

• Proven ability to lead cross-functional teams within a matrix environment.

• Strong stakeholder management and influencing abilities.

• Capability to mentor junior staff and provide strategic direction.

• Compelling interpersonal, verbal, written, and presentation communication skills.

• Strong management and organizational abilities, with a capacity to prioritize and expedite multiple programs and projects.

• High level of independence, integrity, sound judgment, and commitment to compliance.

• Strong attention to detail and dedication to quality.

• Ability to manage multiple complex projects at once.

• Proven ability to work effectively under tight deadlines and shifting priorities.

• High standards of professionalism, integrity, and accountability.

• Commitment to continuous learning and process enhancement.

🏝️ Benefits

• Competitive compensation package.

• Medical insurance.

• Dental insurance.

• Vision insurance.

• Short-term disability (STD).

• Long-term disability (LTD).

• 401(k) Savings Retirement Plan.

• Employee Stock Purchase Plan (ESPP).

• Unlimited Paid Time Off (PTO).