Senior Manager Medical Writing

Location: City Of London

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* Title:

** Senior Manager Medical Writing
** Company:
** Ipsen Biopharm Ltd
** About Ipsen:
** Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas:
Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries.

We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!

For more information, visit us at and follow our latest news on and .
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* Job Description:

***
* Job Title:

** Sr. Manager Medical Writing
** Division / Function:
** Medical Writing (Global Clinical Development Operations)
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* 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 -…