Director – Medical Writing

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

📋 Description

• Direct the medical writing strategy for designated development programs throughout all phases of product development.

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

• Create document plans, timelines, and resource strategies to facilitate regulatory milestones and corporate goals.

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

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

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

• Oversee the planning, drafting, coordination, review, and finalization of various clinical development documents including, but not limited to:

• - Clinical study protocols and protocol amendments

• - Investigator brochures (IBs)

• - Clinical study reports (CSRs)

• - Clinical development plans

• - Statistical analysis plan summaries

• - Clinical overviews and summaries

• - Integrated summaries of safety (ISS)

• - Integrated summaries of efficacy (ISE)

• - Synopses and executive summaries

• Ensure that documents are scientifically accurate, data-driven, and compliant with relevant ICH, FDA, EMA, PMDA, NMPA, and other global standards.

• Collaborating with the regulatory lead and relevant Subject Matter Experts, spearhead the development of regulatory submission documents including, but not limited to:

• - INDs and IND amendments

• - CTAs and CTA amendments

• - Documents for NDAs, BLAs, MAAs, and supplements

• - Briefing materials for interactions with health authorities

• - Nonclinical and Clinical Module 2 documents (2.4-2.7)

• - Orphan drug applications

• - Breakthrough Therapy, Fast Track, and other expedited pathway applications

• - Pediatric Study Plans and Pediatric Investigation Plans

• Ensure that all documents adhere to ICH, GCP, CTD, and applicable regulatory guidance requirements.

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

• Maintain quality control and consistency across documents and programs.

• Support readiness for inspections and document audit activities.

• Stay informed about evolving regulatory expectations and industry standards.

• Manage external medical writing vendors and consultants.

• Oversee outsourced writing tasks, quality, timelines, and budgets.

• Review and approve deliverables generated by vendors.

• Assist in vendor selection and performance management.

• When applicable, mentor and develop internal medical writers.

• Contribute to departmental strategic planning and organizational growth.

• Lead initiatives for process improvement and the implementation of best practices.

• Participate in recruitment, performance management, and talent development activities.

• Act as a subject matter expert in medical writing and regulatory document development across the organization.

⛳️ Requirements

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

• A minimum of 10 years (Director) to 12 years (Senior Director) of experience with a significant emphasis on medical writing in biotechnology, pharmaceutical, CRO, or similar environments.

• Demonstrated experience and knowledge in leading and executing medical writing strategies in a fast-paced bio-pharma context or shown progression from large/medium pharmaceutical organizations to biotech.

• Willingness to travel for business 10-20% as necessary.

• For Senior Director: Experience in managing medical writing teams and/or external vendors is preferred.

• Strong understanding of drug development and combination product development.

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

• Significant expertise in preparing various nonclinical, clinical, and regulatory documents.

• Familiarity with regulatory requirements across major health authorities (FDA, EMA, PMDA, MHRA, Health Canada, NMPA, ANVISA, etc.).

• Familiarity or experience with VEEVA RIM, Starting Point templates, EndNote, and other technical tools for document efficiency and quality.

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

• Excellent data interpretation and synthesis abilities.

• Strong critical thinking and problem-solving skills.

• Ability to identify data gaps and develop scientifically sound messaging strategies.

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

• Strong stakeholder management and influencing abilities.

• Capability to mentor junior staff and provide strategic direction.

• Exceptional interpersonal verbal, written, and presentation skills for communication with internal and external stakeholders.

• Strong management and organizational skills with the ability to prioritize and expedite multiple programs and projects.

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

• Keen attention to detail and dedication to quality.

• Proficient in managing multiple complex projects simultaneously.

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

• High level of professionalism, integrity, and accountability.

• Commitment to continuous learning and process enhancement.

🏝️ Benefits

• Medical

• Dental

• Vision

• Short-Term Disability (STD)

• Long-Term Disability (LTD)

• 401(k) Savings Retirement Plan

• Employee Stock Purchase Plan (ESPP)

• Unlimited Paid Time Off