Director, Medical Writing Lead, Rare Disease

About the Role

The Director, Medical Writing Lead establishes strategies within the assigned Therapy Area to drive clinical study and regulatory document authoring to the highest quality and regulatory standards. This hands-on role requires independently writing or directing the writing of medical and regulatory documents, managing internal and external medical writing resources, and leading medical writing activities for US, European, and other regulatory submissions. The role ensures data is presented objectively in a clear, concise format that withstands regulatory scrutiny and is accountable for timely, high-quality document preparation while staying within assigned budgets.

Responsibilities

• Leadership / Management:
  • Lead and manage medical writers or medical writing service providers, providing coaching, guidance, and mentorship.
  • Proactively collaborate with study/project teams to identify, resource, and deliver medical writing deliverables on time and to quality expectations.
  • Determine resource needs and communicate them to the Head of Medical Writing; develop contingency plans for business needs.
  • Contribute to building capabilities and technical skills across the medical writing department.
  • Stay updated on regulatory expectations for document content and ensure team awareness of developments impacting medical writing standards.
  • May serve as backup to the Head of Medical Writing at leadership meetings.
• Medical Writing:
  • Serve as an expert document author, directing and supervising the authoring of documents in compliance with ICH-GCP, regulatory guidelines, R&D SOPs, and Ipsen policies.
  • Conduct scientific literature searches to contextualize study design and results.
  • Collaborate with study teams, regulatory, and pharmacovigilance to ensure early medical writer input in document development.
  • Lead document strategies and messaging collaboratively with subject matter experts.
  • Perform critical content reviews, interpret results, identify limitations, and discuss unexpected findings.
  • Ensure clear, factual, and concise presentation of analyses in assigned documents.
  • Critically review documents for scientific content, clarity, accuracy, and consistency with company position.
  • Drive the use of the EDMS (Electronic Document Management System) for key study documents.
• Project Deliverables:
  • Plan, schedule, and track medical writing activities in cooperation with clinical operations and study teams.
  • Deliver assigned documents on or before deadlines, alerting teams of potential delays or quality issues.
  • Stay within assigned budgets.
• Quality and Operational Deliverables:
  • Identify process improvement opportunities and contribute to operating procedures.
  • Participate in the identification and qualification of external medical writing services.
  • Engage in oversight meetings for medical writing services and evaluate provider performance.
  • Ensure quality-related deviations are identified, reported, and remediated.
  • Provide regular status reports and performance dashboards to the Head of Medical Writing.
• Environmental, Health, and Safety (EHS):
  • Respect and enforce applicable EHS regulations and procedures.
  • Promote EHS dynamics within teams and participate in accident prevention initiatives.
  • Ensure completion of mandatory EHS training by the team.

Requirements

• 10+ years of experience in clinical and regulatory medical writing within pharmaceutical, biotechnology, academic, or CRO settings.
• Experience leading, planning, writing, coordinating, and overseeing clinical dossiers for global regulatory filings, including CTD submissions.
• Proven track record authoring clinical protocols, study reports, investigator brochures, and regulatory dossier-level documents in relevant therapeutic areas.
• Substantial knowledge of varied therapeutic areas, regulatory and scientific guidelines, and key statistical concepts.
• Advanced knowledge of global regulatory submission requirements, document management systems, and drug development aspects (nonclinical, pharmacokinetics, biostatistics).
• In-depth understanding of Good Clinical Practices, FDA regulations, ICH guidelines, and clinical/pre-clinical pharmaceutical R&D.
• Ability to rapidly assimilate knowledge in new therapeutic areas and present information clearly and logically.
• Strong verbal, nonverbal, and listening skills for problem-solving, negotiation, and decision-making.
• Highly organized, proactive, and accountable for quality and timelines; experienced in managing multiple priorities.
• Operational project management experience, including planning, prioritization, problem-solving, and process improvement.
• Experience managing medical writing projects in an outsourced model or leading remote teams.
• Cross-cultural understanding and sensitivity; professional representation of the company.
• Ability to see the big picture while maintaining attention to detail and taking initiative with a positive attitude.
• Proficient with MS Office Suite (Excel, Word, PowerPoint), MS Project, and document management systems.

Qualifications

• Graduate Degree (Master’s or Doctorate preferred) in a relevant scientific discipline.
• Fluent in English; French is a plus.

Pay

The annual base salary range for this position is $177,000–$259,600 USD. This role is eligible for short-term and long-term incentives programs.

Benefits

• Comprehensive employee benefits package, including 401(k) with company contributions.
• Group medical, dental, and vision coverage.
• Life and disability insurance (short- and long-term).
• Flexible spending accounts.
• Parental leave and paid time off.
• Discretionary winter shutdown.
• Well-being allowance and commuter benefits.