[Hiring] Senior Manager, Medical Writing @SERVIER MONDE

Role Description

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.

• Serve as the main medical writing contact on study teams ensuring accuracy, consistency, and regulatory compliance in a variety of clinical regulatory documents.
• 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 and other strategic regulatory documents such as accelerated review applications.
• 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.

Qualifications

• Bachelor’s degree in relevant scientific/clinical/regulatory field required; Advanced degree preferred.
• Minimum of 7 years of Medical Writing experience.
• 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.
• 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.

Requirements

• 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.
• Some domestic and international travel may be required.
• This role is 100% remote.

Benefits

• Salary range: $157,000 - $180,000.
• Short-Term and Long-Term incentive programs.
• Comprehensive benefits package including medical, dental, vision, and flexible time off.
• 401(k), life and disability insurance, recognition programs.