Agios (agios.com) is a biopharmaceutical company committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with cancer and rare genetic diseases. We are growing rapidly with an active research and discovery pipeline across both therapeutic areas. Agios has two approved oncology precision medicines and multiple first-in-class investigational therapies in clinical and/or preclinical development.. Position Description:. We are seeking an independent, proactive, experienced medical writer with demonstrated project and people management skills to provide leadership for preparing key clinical regulatory documents.. Reporting to the Director of Medical writing, the incumbent will plan and produce medical writing deliverables for the Oncology program at Agios while managing a team of contract/vendor writers. The Associate Director, Medical Writing will create and manage others' contributions to clinical regulatory documents, according to company guidelines and international governmental regulations.. As an integral part of the clinical team, the Associate Director, Medical Writing, will ensure the quality, compliance with internal and external standards, and timely and efficient production of English-language regulatory documents. This role may contribute scientific knowledge, analytical skills, experience, independence, and insight to the analysis of data, the preparation of reports, and the production of submissions.. Primary Responsibilities Include:. Serve as the medical writer contributing to a variety of clinical documents, including clinical protocols, clinical study reports, investigator's brochures, and clinical sections of investigational new drug applications, marketing applications, and briefing documents.. Coordinate the efforts of cross-functional teams to produce high-quality, scientifically accurate documents; contribute to overall project management to facilitate efficient document development and finalization.. Ensure that deliverables meet all applicable regulations, standards, and guidelines, including International Conference on Harmonisation (ICH) guidelines and Agios' style guide.. Manage contract/vendor writers.. Education and Skills Requirements:. 8 - 10 years' experience as a medical or scientific writer within the pharmaceutical industry.. Advanced degree (MS + ) in life sciences or equivalent. Highly prefer prior hands on experience with marketing applications.. Experience managing or mentoring other writers.. Ability to interpret and to clearly and succinctly present complex clinical and scientific data.. Excellent written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy.. Demonstrated organizational skills, ability to prioritize, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines.. Ability to work both independently and collaboratively on a cross-functional team; ability to communicate effectively with team members and other stakeholders.. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.. Experience with oncology writing, preferably.. Experience with the advanced features of Microsoft Word; ability to work effectively within a document management system.. Agios Pharmaceuticals is a public American pharmaceutical company focused on developing small-molecule anti-cancer therapeutics targeting... Associated topics: ancmg, aoa, hem onc, hematology, lah, oncology, palliative, physician md, physician md do, thedacare
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