Are you looking for your next step in your career? Would you like to represent the core of Medical Writing at Biogen?

The Associate Principal Medical Writer will provide medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials. You 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), to create/author/manage documentation required to support clinic, al trials and regulatory submissions.

Furthermore, you will participate on cross-functional teams and influence decision-making, lead strategy discussions related to document development, and make recommendations for process improvements within department and participates in discussions to implement change.

Key Responsibilities

• Independently prepares moderately complex clinical documents such as clinical study reports, Investigator’s brochures, protocols and protocol amendments, and briefing documents, for one or more programs; coordinates preparation of clinical documents by other writers with minimal supervision
• Represents department on cross-functional clinical teams ; 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 formatting
• Participates on departmental initiatives
   

• Solid regulatory writing experience with Master’ or regulatory writing experience with PhD
• Strong written and oral communication skills
• Excellent 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, e.g., Word, Excel, PowerPoint, Adobe Acrobat, electronic document management systems, and collaborative reviewing platforms), ability to understand and utilize digital platforms and solutions
• Ability to communicate and work in English

The Associate Principal Medical Writer will provide medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials.