Sr. Manager, Medical Writing

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About Servier

Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018. As a privately held organization, Servier is uniquely positioned to advance cutting-edge science, tackle underserved therapeutic areas, and make patients the focus of every strategic decision. 

Role Summary

The Sr. Manager, Medical Writing will be responsible for the creation of English-language medical writing deliverables at Servier Pharmaceuticals US (Servier), ensuring the high-quality, timely, and efficient development of nonclinical, clinical, and regulatory documents that comply with internal and external standards.

The Sr. Manager, Medical Writing will:

• Act as lead author of regulatory and other scientific documentation.
• Manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations.
• Mentor junior writing staff.
• Manage external vendor writer activities.
• Act as the Medical Writing point of contact for a particular drug development franchise within Servier.

Document examples include but will not be limited to nonclinical study reports and CTD modules, clinical protocols, clinical study reports, investigator’s brochures, and clinical sections of investigational new drug applications and marketing applications. Strategic regulatory documents such as agency responses and briefing packages will also be written/managed.  

Varied sentence structure (long and short) helps for an exciting flow.

Primary Responsibilities

The Sr. Manager, Medical Writing will ensure that nonclinical and clinical regulatory documents (eg, study reports, study protocols, clinical summaries/overviews, investigator’s brochures, scientific publications, contributions to response documents, and other global regulatory submission documents as appropriate) accurately and consistently present key clinical messages in accordance with program goals and regulatory requirements, and that continuity and consistency of data are maintained from concept to licensing and disclosure.

Activities (performed with minimal supervision) will include, but will not be limited to:

• Editing, writing, development of timelines, project management, and participation on project teams.
• Serve as the main medical writing contact on study teams.
• Work independently to coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents.
• Ensure that deliverables meet all applicable regulations, standards, and guidelines, including ICH guidelines.
• Mentor and manage the work of junior writers as needed.
• Manage the work and deliverables of contract/vendor writers, as needed.
• Participate in the preparation of responses to questions from regulatory agencies and 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.
• Maintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs.
• Influence cross-functionally to improve procedures or practices as needed to remain within regulatory compliance and promote internal quality and efficiency.

A successful candidate must be able to:

• Manage multiple projects with competing priorities.
• Work within a program/franchise with minimal supervision.
• Work in a global team environment with ability to maintain strong relationships with the global medical writing management and local US MW, Biometric management.

Education and Required Skills

• Bachelor’s degree in a relevant discipline
• 5 years of regulatory medical writing experience
• Experience as a lead writer/medical writing point of contact for marketing applications (NDA/BLA)
• Global regulatory submission experience
• Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed and critically evaluate the outsourcing strategy.
• Excellent verbal and written communication skills

• Exceptional organizational skills and attention to detail
• Project management skills (MS Project experience preferred) and familiarity with GCP and ICH guidelines.
• Technical skills with relevant software for authoring such as MS Word and EndNote (the ability to use PleaseReview and an abbreviation manager/QC tool is desirable)
• The ability to remain flexible should priorities change (judgment and decision making) during project execution.

Preferred Skills

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

Travel and Location

• Remote position
• Some domestic and international travel may be required.

Servier’s Commitment

Servier is committed to modeling diversity, equity, and inclusion within the industry. We are dedicated to fostering an environment that maintains equitable treatment for all and we welcome applicants who are passionate, committed, and innovative individuals. We encourage candidates to apply to our open roles as we are always willing to consider experiences and skills beyond what is listed in the job description.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Salary Range

The salary range for this role is $125,000 to $155,000 depending on experience. An employee’s pay position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, performance, and business or organizational needs. We may ultimately pay more or less than the posted range, and the range may be modified in the future. Employees in this position are also eligible for Short-Term and Long-Term incentive programs. Servier also offers a competitive and comprehensive benefits package that includes benefits such as 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 among other great benefits (all benefits are subject to eligibility requirements).  For more information on our benefits, please visit this link.

Signed………………………………………                                          Date…………………………

Position Holder

Signed……………………………………….                                         Date…………………………

Head of Human Resources