Manager, Medical Writing in Boston, MA

Manager, Medical Writing - Servier - Boston, MA - work from home job Company: Servier Job description: About Servier At Servier, we are dedicated to bringing the promise of tomorrow to the patients we serve. We are a commercial stage, privately held pharmaceutical company, based in the U.S. Currently, we have four medicines approved in acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML) and cholangiocarcinoma (CCA). We have also accelerated our investment in hard-to-treat cancers, with more than 50% of our research and development dedicated to delivering significant advances in areas of high unmet need that may truly move the needle for our patients. Our pipeline is promising with several Phase 3 assets in the Oncology space. Role Summary The 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 clinical and regulatory documents that comply with internal and external standards. The Sr. Manager, Medical Writing will 1) be the lead author of regulatory and other scientific documentation, 2) manage the overall collection of content from cross functional teams to produce documents according to company guidelines and international governmental regulations, 3) mentor junior writing staff, 4) manage external vendor writer activities and 5) be the Medical Writing point of contact for a particular drug development franchise within Servier. Primary Responsibilities • Work cross-functionally to write clinical and regulatory documents in support of regulatory submissions to accurately and consistently present key clinical messages in accordance with program goals, regulatory requirements, standards, and guidelines • Serve as the main medical writing contact on study teams, coordinating the efforts of cross-functional teams for document development • Mentor and manage the work of junior writers • Manage the work and deliverables of contract/vendor writers Education and Required Skills • Bachelor's degree in a relevant scientific/clinical/regulatory field required, MS or graduate level degree preferred • Five years of medical writing experience (dependent upon graduate degree) • Direct experience writing Module 2 documents for submission to Health Authorities • 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 • Proficiency with relevant software for document authoring, referencing and approval workflows • Flexibility and agility with changing priorities and timelines Travel and Location • Some domestic and international travel may be required • This role can be 100% remote Servier's Commitment We're an organization, committed to modeling diversity, equity, and inclusion for the entire industry, and to maintaining an inclusive environment with equitable treatment for all. We are interested in growing our team with passionate, committed, and innovative individuals. We encourage all to apply to our open roles and are always willing to consider skills and experiences outside of what is listed in the job description. Expected salary: Location: Boston, MA Job date: Sun, 03 Sep 2023 07:23:44 GMT Apply for the job now! Apply tot his job Apply To this Job