Senior Manager, Medical Writing

SERVIER MONDE

13d • Remote

About The Position

The Sr Manager, Medical Writing will lead the development of high-quality, compliant English-language non-clinical, clinical, and regulatory documents within the Medical Writing department at Servier Pharmaceuticals US. This role will report into the Director, Medical Writing.

Responsibilities include serving as lead author of regulatory and scientific documents, managing the collection of content from cross-functional teams ensuring compliance with internal and external standards, mentoring junior writers, overseeing vendor activities, and acting as the Medical Writing point of contact for an assigned drug development franchise.

Documents include, but are not limited to, clinical study reports, protocols, summaries/overviews, investigator’s brochures, scientific publications, clinical sections of investigational new drug applications, contributions to agency response documents, and other global regulatory submission materials.

Requirements

• Bachelor’s degree in relevant scientific/clinical/regulatory field required with a minimum of 7 years of Medical Writing experience; Advanced degree in a relevant scientific/clinical/regulatory field preferred
• Experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA)
• Strong project management skills with the ability to manage multiple projects with competing priorities; proficiency with MS Project preferred
• Excellent verbal and written communication skills, with the ability to collaborate effectively in a global team environment and build strong cross-functional relationships
• Exceptional organizational skills, attention to detail, and ability to work independently with minimal supervision
• Ability to adapt to changing priorities and exercise sound judgment in decision-making
• Technical proficiency with authoring software such as MS Word and End Note; experience with abbreviation managers/QC tool is desirable
• Experience partnering with CROs to ensure adherence to best practices and evaluating outsourcing strategies
• Global regulatory submission experience
• Familiarity with GCP and ICH guidelines

Nice To Haves

• History of successful preparation and submission of a major regulatory marketing application
• Experience with authoring/management of clinical and non-clinical documents for drug development

Responsibilities

• Serve as the main medical writing contact on study teams ensuring accuracy, consistency, and regulatory compliance in a variety of clinical regulatory documents as outlined above
• Author, edit, and manage project deliverables, including timeline development, project management, and active participation on cross-functional project teams
• Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents meeting all applicable regulations, standards, and guidelines, including ICH
• Prepare responses to questions from regulatory agencies; write briefing packages, other strategic regulatory documents such as accelerated review applications, and assist with materials for presentations at agency meetings and advisory committee meetings as needed
• Mentor and manage the work of junior writers as needed
• Manage the work and deliverables of contract/vendor writers, as needed
• Promote continuous improvement by influencing cross-functional practices to enhance quality, compliance, and efficiency
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs

Benefits

• medical
• dental
• vision
• flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off)
• 401(k)
• life and disability insurance
• recognition programs

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 251-500 employees