Job Title

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 SummaryThe 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.Primary ResponsibilitiesServe as the main medical writing contact on study teams ensuring accuracy, consistency, and regulatory compliance in a variety of clinical regulatory documents as outlined aboveAuthor, edit, and manage project deliverables, including timeline development, project management, and active participation on cross-functional project teamsCoordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents meeting all applicable regulations, standards, and guidelines, including ICHPrepare 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 neededManage the work and deliverables of contract/vendor writers, as neededPromote continuous improvement by influencing cross-functional practices to enhance quality, compliance, and efficiencyMaintain awareness of industry standards, regulatory requirements, and departmental guidelines and SOPsEducation and Required SkillsBachelor'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 preferredExperience 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 preferredExcellent verbal and written communication skills, with the ability to collaborate effectively in a global team environment and build strong cross-functional relationshipsExceptional organizational skills, attention to detail, and ability to work independently with minimal supervisionAbility to adapt to changing priorities and exercise sound judgment in decision-makingTechnical proficiency with authoring software such as MS Word and End Note; experience with abbreviation managers/QC tool is desirableExperience partnering with CROs to ensure adherence to best practices and evaluating outsourcing strategiesGlobal regulatory submission experienceFamiliarity with GCP and ICH guidelinesDesirable:History of successful preparation and submission of a major regulatory marketing applicationExperience with authoring/management of clinical and non-clinical documents for drug developmentTravel and LocationSome domestic and international travel may be requiredThis role is 100% remoteJob DescriptionCandidate ProfileServier's CommitmentServier 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 RangeThe salary range for this role is $157,000 - $180,000. 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.