Senior Manager Medical Writing

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Job Title: Sr. Manager Medical Writing
Division / Function: Medical Writing (Global Clinical Development Operations)
Location: London (Primary Location); US (Secondary)

Summary & Purpose Of The Position
The Sr. Manager, Medical Writing is a strategic and operational leader responsible for overseeing the planning, development, and delivery of high-quality clinical and regulatory documents across multiple assets and therapeutic areas. This role ensures alignment with global regulatory standards, drives innovation in medical writing practices, and fosters excellence across internal and external writing teams.

The Sr. Manager provides leadership across cross-functional teams, contributes to regulatory strategy, and ensures timely, compliant, and scientifically sound documentation to support clinical development and regulatory submissions.

Main Responsibilities & Technical Competencies

Strategic Leadership & Oversight

• Lead medical writing strategy across multiple programs or therapeutic areas, ensuring alignment with regulatory and clinical development goals.
• Serve as a key partner to Regulatory Affairs, Clinical Development, and Safety teams in shaping submission strategies and timelines.
• Represent Medical Writing in cross-functional governance forums and regulatory interactions.

Team & Vendor Management

• Supervise and mentor Medical Writing Project Leads and Senior Medical Writers.
• Oversee outsourced medical writing activities, ensuring quality, consistency, and adherence to timelines and budgets.
• Drive capability building and continuous learning across the medical writing function.

Document Development & Quality

• Responsible for delivery and resourcing of all writing activities for assets as assigned.
• Experienced in writing/preparation of documents needed for clinical development from FIH through Phase 3 and Regulatory submissions including any regulatory interactions with agencies.
• Ensure consistency of messaging across documents and adherence to internal standards and regulatory requirements.
• Manage deliverables: assign work to writers, monitor quality, ensure consistency, and adherence to timelines.

Process Improvement & Innovation

• Actively contributes to best practices and continuous improvement across asset teams.
• Champion process optimization, automation, and digital tools to enhance efficiency and scalability.
• Contribute to the development and implementation of medical writing SOPs and best practices.

Project Delivery

• Able to work across multiple assets simultaneously.
• Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work.
• Highly organised, proactive, respects metrics driven timelines, and accountability for quality.
• Adhere to the quality control process and ensure all work produced has gone through the correct internal review process.
• Demonstrate a good understanding of project management and resource planning.
• Maintain a working knowledge of pharmaceutical industry standards and compliance.

Communication

• Ability to present information in a clear, accurate, and logical manner. Solid understanding of the target audience needs.
• Well-honed verbal, non-verbal and listening skills for problem solving, negotiation, and decision-making.
• Patient and open to tough critiques.
• Provide regular feedback to senior team members across assets.

EHS Responsibilities

• Respect and enforce applicable EHS regulations and procedures.
• Promote EHS dynamics within teams for the proper functioning of the EHS management system.
• Participate in the prevention of accidents at work by carrying out the Managerial Safety Visits (VMS) of its employees.
• Ensure the completion of mandatory EHS training by his/her team.

Behavioural Competencies Required

• Purpose Dedication.
• Anchors Ipsen’s mission and purpose, keeping patients at the center of all deliverables.
• Creates and communicates a compelling vision for Medical Writing activities within assigned programs.
• Demonstrates strong customer and patient focus by integrating patient voice and perspectives into regulatory and clinical documentation.
• Thinking Dexterity.
• Brings a holistic, strategic perspective to complex clinical and regulatory challenges.
• Demonstrates analytical agility and strong business insights, using data and external trends to inform planning and decision-making.
• Encourages innovation in writing processes, digital tools, and resource models.
• Social Agility.
• Instills trust by role-modelling integrity, transparency, and authenticity in all interactions.
• Demonstrates empathy and creates safe, inclusive environments where internal and external writing teams can thrive.
• Drives engagement and motivation across global, matrixed teams.
• Growing Self and Others.
• Demonstrates self-awareness and actively seeks feedback to continuously improve leadership effectiveness.
• Coaches and develops Medical Writing staff and vendor partners, providing structured feedback, mentoring, and opportunities for growth.
• Being Intentional.
• Communicates effectively and adapts style to different audiences.
• Influences across functions without direct authority, forging “win-win” solutions and shared ownership.
• Making a Real Impact.
• Consistently delivers high-quality, compliant, and timely documents that directly contribute to program success and patient benefit.
• Builds effective, diverse teams and fosters collaboration across Clinical Development, Regulatory, Safety, and Biometry.

Knowledge & Experience

• Bachelor’s degree in Life Sciences (advanced degree preferred).
• Medical Writing experience in either a CRO or pharmaceutical company (Minimum of 7 years).
• Demonstrated budget- and people-management success.
• Proven leadership experience managing teams and vendors in a matrixed, global environment.
• Demonstrated success in leading regulatory writing for major submissions.
• Strong understanding of ICH guidelines, GCP, and global regulatory requirements.
• Excellent time management skills and demonstrated ability to forecast and manage workload.