Medical Writing Lead

**Title**:
Medical Writing Lead

**Company**:
Ipsen Innovation (SAS)

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 is a hands-on role, requiring the Medical Writing Lead to independently write or direct writing of medical and regulatory documents.
- Manages medical writing resources (internal and external) assigned to support document development.
- Leads medical writing activities for US, European and other regulatory submissions as assigned.
- Responsible for ensuring data is presented and documents are written objectively in a clear, concise format and able to withstand examination by regulatory bodies.
- Accountable for own work and that of his/her assigned medical writers such that documents are prepared, reviewed, and approved in a quality and timely manner.
- Accountable for staying within the assigned medical writing budgets and for oversight of all medical writing 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 mínimal oversight and direction within an asset centric matrix organization. - Proactively collaborates within their assigned study/project teams to ensure all medical writing deliverables for a given study and targeted submission plan are prospectively identified, included in the project plan, adequately resourced and are delivered on time and to quality expectations. - 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. - Stay up to date on regulatory expectations in regards document content for study and submission requirements and ensures team awareness of developments impacting medical writing standards. - Determine resource needs based on workload and project priorities and communicate to the Head of Medical Writing in a timely fashion. - Work with the Head of Medical Writing to develop contingency plans to address the business needs based on current therapeutic area projects and anticipation of future therapeutic area projects. - May serve as back up to Head of Medical Writing at leadership meetings 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, R&D SOPs and other Ipsen policies. - Conducts searches of scientific literature to place study design considerations and study results in context with other relevant data. - 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 as early as

Education / Certifications:

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

**Experience**:

- 7+ years’ experience with a Graduate Degree (Pharmaceutical, Biotech, Academic, CRO)
- 10+ years’ experience with a Bachelor's Degree (Pharmaceutical, Biotech, Academic, CRO) - Experience with leading, planning, writing, coordinating, and overseeing the clinical dossier for global regulatory filings
- Regulatory Medical writing & CTD Submission writing experience essential
- Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts.
- 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.
- Awareness and understanding of clinical / pre-clinical pharmaceutical research and development arena
- Demonstrated ability to assimilate knowledge and understanding of a new therapeutic area
- Experience managing medical writing projects within a predominately outsourced model, or leading remote based medical writing teams (internal or external).
- Accepts responsibilities, delegates efficiently, maintains accountability
- Operational project management experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing mul