Are you an experienced Medical Writer that can work independently? Would you like to represent the core of medical writing at Biogen?
The Principal Medical Writer will interact with other medical writers, document managers, document quality reviewers, and cross-functional teams (e.g., study management teams, clinical development teams, process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions.
You will lead cross-functional team and drives decision making, lead strategy-related discussions related to document development, identify areas for process improvements within and without department, and lead discussions to implement change.
- Independently prepares complex clinical documents such as clinical study reports, Investigator’s brochures, protocols and protocol amendments, briefing documents, responses to regulatory agencies; independently coordinates preparation of clinical documents for regulatory submissions and/or publication strategies for one or more programs
- Represents department on clinical teams (e.g. study management team, clinical development team); leads document-related meetings; reviews statistical analysis plans and clinical data reports to ensure consistent data reporting within a program and/or therapeutic area
- Mentors junior writers on departmental processes related to document preparation (e.g., planning document-related meetings, developing document timelines); reviews documents written by junior writers for content and format; coordinates work of multiple writers contributing to a regulatory submission,
- Leads departmental initiatives; represents department on interdepartmental initiatives.
- Proven experience in regulatory writing with a Master’s
- Regulatory writing experience with PhD
- Formidable organizational and meeting skills
- Solid understanding of therapeutic area(s)
- Strong understanding of standard clinical document types and ability to interpret data
- Solid understanding of internal and external guidelines related to document preparation
- Robust IT and digital skills and knowledge, be able to quickly understand and utilize new digital platforms and solutions, e.g., electronic document management systems, collaborative authoring and reviewing platforms
- Excellent written and oral communication skills.
- Ability to communicate and work in English
- Master’s required
- PhD preferred
- Life or Health Science discipline
Experience working in the pharmaceutical/CRO industry strongly preferred.
The Principal Medical Writer will interact with other medical writers, document managers, document quality reviewers, and cross-functional teams, in order to create/author/manage documentation required to support clinical trials and regulatory submissions.