Senior Manager, Medical Writing

What You’ll Do: Reporting to the Head of Medical Writing, the Senior Manager, Medical Writing will be responsible for directly authoring and managing the development of high-quality medical and scientific documents to support the development, regulatory approval, and commercialization for one or more of our products. This role requires close collaboration with cross-functional teams to ensure timely, compliant, and high-standard deliverables that meet global regulatory requirements. The ideal candidate will have extensive experience in medical writing and scientific communications, with a strong understanding of both early- and late-stage drug development processes.

Responsibilities:

• Author and manage regulatory documents for global submissions in accordance with ICH and other international guidelines, internal standards, and project timelines.
• Lead and coordinate medical writing activities for assigned programs, including internal teams and external vendors, ensuring timely and accurate submissions to regulatory authorities.
• Provide strategic input on medical writing deliverables, timelines, and processes during cross-functional meetings.
• Drive process improvements and serve as a subject matter expert on document types, workflows, and technologies.
• Partner with the Head of Medical Writing to evaluate and implement innovative approaches to document development, review, and quality control.
• Partner with the Head of Medical Writing to develop and maintain SOPs, templates, and best practices to ensure consistency and efficiency in document preparation.
• Oversee contract writers as needed, including defining scopes of work and monitoring deliverables and budgets.
• Apply therapeutic area and product knowledge to ensure scientific accuracy and clarity in all documents.
• Collaborate with internal stakeholders to establish style standards and quality control measures for high-quality outputs.

Qualifications:

• Advanced degree (PhD, PharmD) in a scientific discipline preferred; Master’s degree with at least 5 years of medical writing experience in pharma/biotech required.
• In-depth knowledge of regulatory requirements and guidelines (ICH, GCP, FDA, EMA) and familiarity with AMA style.
• Exceptional writing, editing, and verbal communication skills.
• Strong project management skills with the ability to prioritize and manage multiple projects.
• Proficiency with medical writing tools and software.
• Meticulous attention to detail and commitment to quality.
• Solid understanding of the drug development process and strong business acumen.
• Experience managing vendors and contractors is a plus.
• Strategic thinker with analytical skills and ability to thrive in a fast-paced environment.
• Collaborative team player with strong interpersonal skills and ability to build effective relationships across functions and with external partners.

Location: This is a hybrid role with three days per week in-office in Burlington, Massachusetts.