Associate Principal Medical Writer – Biogen, Cambridge, MA

Associate Principal Medical Writer - Biogen, Cambridge, MA

• Cambridge, MA
• Employees can work remotely
• Full-time
• Department: Regulatory
• Region: US

Job Description

The Associate Principal Medical Writer will interact with other medical writers, document managers, document quality reviewers, and cross-functional teams (e.g., SMT, CDT, process improvement committees), in order to create/author/manage documentation required to support clinical trials and regulatory submissions. Successful candidate will participate in cross-functional teams and influences decision making. They may lead strategy discussions related to document development and make recommendations for process improvements within department and participates in discussions to implement change.

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Principal Accountabilities

·       Independently prepares moderately complex clinical documents for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision

·       Represents department on clinical teams (e.g., SMT, CDT); leads document-related meetings; reviews statistical analysis plans and clinical data reports as needed

·       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

·       Participates on departmental initiatives

Qualifications

·       Master’s required in a life science or health discipline. PhD preferred

·       4+ yrs. regulatory writing experience within a life science organization

·       Ability to interpret data within a specific therapeutic area (neuroscience ideal)

·       Solid understanding of standard clinical document types

·       Solid understanding of internal and external guidelines related to document preparation

·       Strong written and oral communication skills

·       Strong organizational and meeting skills

Additional Information

All your information will be kept confidential according to EEO guidelines.

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Language: English

Company: Biogen

Contact Person: Vera Buris, Senior Manager, Global Safety and Regulatory Sciences (GSRS)

Email: vera.buris@biogen.com

Phone: 617-914-5319

Assignment Date: 02/10/2021

Location: 300 Binney Street, 93C27, Cambridge, MA 02142