JOB TITLE: Medical Writer (Senior)
JOB LOCATION: Canada, United States, UK, Germany, or the Netherlands (Home-based)
REPORTS TO: Team Lead, Scientific Writing
DEPARTMENT/UNIT NAME: Medical R&D
Lead scientific writing projects for Clinical Research Scientists, Sponsors, Academic partners, and/or Alimentiv. Interpret and translate complex technical research data, findings or methodologies into regulatory documents (protocols, investigator brochures, clinical study reports, informed consent forms, etc.) on a timely basis that align with industry, regulatory and academic style and content guidelines and standards. Coordinate document reviews. Develop and track timelines for assigned writing projects. Provide mentorship and support to other writing team members. Act as primary contact for external publishing if required. Assist with review or editing of other materials (grants, study operations, training, communications, etc.) when requested.
ROLE AND RESPONSIBILITIES:
Clinical Research/Academic Writing Support
Team Support and Mentorship
Act as primary contact and liaison with external publication executives, illustrators, designers and editors representing the Scientists/Investigators, Sponsors and/or the corporation with external specialists to select publication content, address content change requests, complete written revisions and/or resolve competing content requirements. Provide guidance on Common Technical Document (eCTD) requirements.
Other Writing Support
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