The Senior Medical Writer reporting to the Head of Clinical Program Strategy will have the following responsibilities:

• Role Summary The Medical Writer (Senior Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, investigator brochures, annual safety reporting, briefing documents, clinical summaries for marketing applications, publications, and responses to queries from regulatory authorities.
• Understands the principles of scientific writing, writing with the audience in mind and conveying messages in a clear and concise manner.
• Analyzes, interprets, and distills data and other information to create documents.
• Applies advanced knowledge of relevant regulatory requirements and corporate policies as well as work experience to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.
• Is facile with innovative problem solving and peer influence.
• Role Responsibilities Independently authors complex documents that are compliant with relevant internal processes and standards as well as external regulatory guidance.
• Manages all aspects of document development process and leads project teams through process.
• Oversees all outsourced medical writing activities including timelines and budgets.
• Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• Drives decision making about data presentation strategies to support advance planning of documents.
• Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
• Develops and maintains project timelines.
• Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.
• Communicates Medical Writing’s position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.
• Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line.
• If assigned by manager, serves as the Medical Writing ‘point of contact’ for all document issues for a given asset or set of assets.
• Produces documents in conjunction with vendors as needed.

• Basic Qualifications Bachelor’s degree, preferably in a life science discipline.
• BS/BA +7 years, MS/MA +5 years, PhD +2 years of experience in medical writing or related field
• Understanding of the role of each member of cross-functional team.
• Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
• Ability to manage documents of greater complexity and/or variety.
• Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.
• Adapts to change as needed.
• Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.
• Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data
• Comprehensive understanding of the drug development process and how medical writing documents support development at different stages.
• Comprehensive understanding of medical concepts of the disease and current standard treatments.
• Knowledge of how to use publicly available databases (eg, PubMed, DailyMed, FDA and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.
• Able to interpret analyses of data supporting regulatory/clinical documents and to summarize in clearly written text with minimal guidance from team members.

This role is hybrid and requires three days a week in-person in our Boston office.