Medical Writing Lead, Director F/M

The primary responsibilities of the Medical Writing Lead are to establish strategies within the assigned Therapy Area that drives clinical study and regulatory document authoring to highest quality and regulatory standards.

This role is hands-on role, requiring the Medical Writing Lead to independently write or direct writing of medical and regulatory documents, and manage both internal and external medical writing resources. They will lead medical writing activities for US, European and other regulatory submissions. They are responsible for ensuring data is presented and documents are written objectively in a clear, concise format and able to withstand examination by regulatory bodies. The role also involves accountability for the quality and timeliness of documents prepared by themselves and their assigned medical writers. Additionally, the Medical Writing Lead is responsible for adhering to the assigned medical writing budgets and overseeing all tasks delegated to external medical writing service providers.

Main Responsibilities / Job Expectations

Leadership / Management

• The Medical Writing Lead is an effective team leader capable of working efficiently with minimal oversight and direction within an asset centric matrix organization.
• Directly oversee, develop, and manage medical writers or medical writing service providers; provide leadership, coaching, guidance, and mentorship; ensure management and training of external writers.
• Contribute to building capabilities and technical skills across the medical writing department.
• Determine resource needs based on workload and project priorities.
  
  

Medical Writing

• Lead by example, serving as an expert document author and directing and supervising the authoring of documents within the framework of and in compliance with ICH-GCP, applicable regulatory guidelines, RD SOPs and other Ipsen policies.
• Proactively collaborate with study teams and other functions including but not limited to regulatory and pharmacovigilance, to ensure assigned documents are developed with medical writer input.
• Contribute to formation of key messages in consultation with functional area experts (e.g., recommending data outputs for collection of specific data, proposing document strategy for filings, or responding to health authority requests)
• Critically review documents produced by writers for scientific content and alignment with company position, clarity, accuracy, and consistency
  
  

Additional Duties

• Deliver assigned documents on or before deadline
• Identify Medical Writing process improvement opportunities and contribute to development/maintenance of operating procedures
• Provide regular status reports and performance dashboards to the Head of Medical Writing
• Respect and enforce applicable EHS regulations and procedures.
  
  

Knowledge, Abilities Experience

Education / Certifications:

• Graduate Degree (Masters or Doctorate preferred) in a relevant scientific discipline
  
  

Experience

• 7+ years’ experience within Pharmaceutical, Biotech, Academic, CRO environment.
• Experienced writer of clinical protocols, study reports, investigator brochures, regulatory dossier level documents…etc. Proven track record of medical writing within a relevant therapy area
• Ability to present information in a clear, accurate, logical, and non-technical manner. Solid understanding of the target audience needs.
• Committed to data integrity and reporting standards,
• Well-honed verbal, non-verbal and listening skills for problem solving, negotiation and decision-making. Patient and open to tough critiques
• Highly organised, proactive, respects metrics driven timelines and accountability for quality.
• Demonstrated ability to assimilate knowledge and understanding of a new therapeutic area
• Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities.
  
  

Languages

• Expert level oral and written English
  
  

Key Technical Competencies Required

• In-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
• Strong diagnostic, analytical and process improvement skills
• Cross-cultural understanding and sensitivity
• Managerial capability with proven leadership profile
• Ability to see the big picture, while keeping an eye on the detail.
  
  

This is a permanent position, and the location is flexible - Ipsen UK or France. We also have remote working opportunities available.