Medical Writing Lead

at  Ipsen Biopharm Ltd

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.

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.

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.