Job Description

Job Title:

Sr. Manager Medical Writing

Division / Function:

Medical Writing (Global Clinical Development Operations)

Location:

London (Primary Location); US (Secondary)

WHAT -

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.

WHAT -

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 (e.g., pre-IND, End of Phase 2, end of Phase 3, other Type C etc.) 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 (eg, resolving escalated issues arising from operations and requiring coordination with other departments) 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

HOW - Behavioural Competencies Required

1. 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, aligning teams and vendors with broader development and regulatory strategies. Demonstrates strong customer and patient focus by integrating patient voice and perspectives into regulatory and clinical documentation.

2. Thinking Dexterity

Brings a holistic, strategic perspective to complex clinical and regulatory challenges, connecting dots across therapeutic areas and functions. 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 to enhance quality, efficiency, and scalability.

3. 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; demonstrates courage by constructively challenging the status quo when required.

4. 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. Identifies and attracts high-caliber writing talent, building strong bench strength and succession pipelines.

5. Being Intentional

Communicates effectively and adapts style to different audiences, from regulatory authorities to internal stakeholders. Influences across functions without direct authority, forging "win-win" solutions and shared ownership. Demonstrates adaptability, resilience, and decision-making agility in the face of ambiguity, shifting priorities, or changing regulatory requirements.

6. 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. Holds self and others accountable for outcomes, ensuring clarity of roles, timelines, and responsibilities. Champions excellence in execution, balancing scientific rigor, regulatory compliance, and operational efficiency

HOW - Knowledge & Experience

Knowledge & Experience (essential):


Education / Certifications:


Bachelor's degree in Life Sciences (advanced degree preferred).

Experience:

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 (e.g., NDA/BLA/MAA). Strong understanding of ICH guidelines, GCP, and global regulatory requirements. Recognised industry qualification in Medical Writing (such as the professional development qualifications provided by the American and European Medical Writing Associations) would be advantageous Committed to data integrity and reporting standards, Experience managing medical writing projects within a predominately outsourced model, or leading remote based medical writing teams (internal or external). Ability to work and develop scientific expertise across a range of therapy areas Flexible approach to working, with the ability to reprioritize and work under pressure when needed Excellent time management skills and demonstrated ability to forecast and manage workload

Languages:

English (Excellent level both written and verbal)

Role homebased open in UK or in the US.