Job

Principal/Senior Manager Medical Writing

Your responsibilities include, but are not limited to:

Overall, the Senior Medical Writer is responsible for writing, reviewing, and overseeing the production of clinical, nonclinical, and regultaory documents to support product development and marketing applications.

• Authoring and managing document review and finalization process
• Managing timelines for Medical Writing documents you are authoring
• Reviewing and editing documents written by other functional teams
• Participating in clinical study team meetings and other appropriate clinical development teams meetings as needed to provide input regarding MW deliverables, timelines, and process
• Coordinate with subject matter experts (SMEs) and key stakeholders regarding appropriate document content
• Document authoring includes, but is not limited to: clinical study protocols and amendments, clinical study reports, Investigator’s Brochures, Development Safety Update Reports and other annual reports (eg, ODD annual reports), and CTD sections for IND/NDA submissions and may include authoring of other regulatory documents (eg, briefing documents, responses to information requests)
• Document editing and reviewing may include: nonclinical and/or clinical pharmacology reports and/or CTD sections, CMC documents (as needed), and other documents as needed
• Adhere to company Style Guide, templates, and SOPs for document development
• Participate in the development of departmental SOPs and cross-functional process development in a gowing company

Your profile:

• Fluent in English
• Excellent and established medical writing skills (at least 5 years experience as a medical writer in industry)
• Ability to write clean and concise documents
• Ability to understand and interpret clinical and scientific data
• Ability to author documents in a manner that is understandable to a variety of audiences
• Knowledge of current regulatory guidelines including but not limited to ICH guidelines
• Proficient in MS Word, Power Point, and Outlook
• Excellent time management skills and the ability to manage multiple ongoing projects simultaneously
• Ability to build partnerships with key stakeholders from other functions to ensure strategic business goals are met

Our offer:

• Competitive compensation
• An exciting and multifaceted full-time position
• Become part of a passionate, creative, and collaborative international team

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