Manager Medical Writing

Key ResponsibilitiesDocument Leadership and Authoring:Provides medical writing leadership for clinical programsActs as a medical writing subject matter expert and collaborates with the Clinical Science team to deliver on clinical documents including clinical study protocols and protocol-related documents (e.g. informed consent forms), clinical study reports, DSURs, Investigator's Brochures, IND clinical summaries/overviews, and CTD components (e.g. Module 2 summaries)Partners with the regulatory function to ensure timely completion of high-quality regulatory documents including health authority meeting requests, briefing packages, responses to requests for information, and other documents as required for submissionsVendor Management: Provides guidance to external writers on prioritization, content and timeline development, and process management to support clinical development and regulatory activitiesProcess Improvement:Develops medical writing best practicesPartners with the Quality Assurance team to develop new and update existing Standard Operating Procedures for Medical Writing processes and all clinical documents to ensure compliance with ICH requirementsPosition RequirementsMaster's degree in a life science discipline from an accredited college or university; PharmD or PhD preferredMinimum of 8+ years of scientific or medical writing experience at a biotech/ pharmaceutical company or clinical research organization settingExpert knowledge of standard clinical regulatory document types and associated regulatory requirements (e.g. ICH guidance, FDA, EMA, Health Canada, Asia-Pacific regulations, etc.)Prior writing experience in Clinical Study Protocols, Clinical Study Reports, DSUR, Investigator's Brochures, IND clinical summaries/overviews, CTD clinical summaries, and partnering with external investigators to support Investigator Initiated Study TrialsExpert ability of Microsoft Office Suite, Adobe Acrobat, collaborative review management systems (e.g. SharePoint) and documents management (e.g. Veeva RIM)Experience in resource planning and management experience of contractorsExcellent organization skills with a passion for delivering quality resultsDetail-oriented mindset with excellent verbal and written communication skillsSelf-motivated and able to work collaborativelyAbility to "roll up sleeves" in a start-up environment and a positive can-do attitudeMust be willing to work onsite at least 4 days a week