![]() ![]() Serving as subject matter expert in writing, coordination, management, and completion of submission-ready documents and providing guidance to project team(s) as required. Providing guidance as needed on clinical data being considered for presentation and/or publications to ensure alignment with scientific strategies and corporate goals. Helping to set standards for Forma's document review, completion, and approval processes, ensuring adherence to regulatory requirements, and consistency with America Medical Writing Standards or other writing standards, where applicable. Helping to ensure that quality systems and processes are in place and regularly updated to support the development, review, and approval of medical writing documents and ensure appropriate templates are in place for documents such as, but not limited to, Clinical Study Reports, Protocols, and Investigator Brochures and other documents necessary for regulatory submissions. Key responsibilities include: Ensuring appropriate planning and coordination of medical writing activities across multiple clinical development functions for the successful completion of high quality, submission ready documents on time in support of Forma's clinical and regulatory requirements Serving as the Medical Writing representative for multiple clinical studies/development programs as applicable Managing large and complex medical writing projects which may include supervision of other medical writers and quality reviewers to ensure delivery of documents according to timelines and to acceptable quality standards Providing support to other medical writers to ensure delivery of documents according to timelines and to acceptable quality standards as needed Supporting project teams on all medical writing deliverables, including clinical documents, regulatory submissions, and publications Supervising, mentoring, and training other medical writers and quality reviewers Assisting with the identification, selection, and oversight of qualified vendor(s) or consultants as required to prepare, write, edit, and review clinical and regulatory documents in collaboration with the project teams and serving as the vendor lead and liaison for Medical Writing vendors as needed. ![]() The Associate Director, Medical Writing, provides leadership, guidance, medical writing expertise, and direction to both Forma staff as well as vendors and/or independent consultants responsible for the completion of submission-ready documents. About the Opportunity: The Associate Director, Medical Writing is accountable for assisting with the coordination of all aspects of technical writing for Forma Therapeutics, including program-level medical writing support and coordination, resource planning and execution across all development programs, supervising, training and mentoring junior writers, and vendor selection and management. ![]()
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