Senior Manager, Medical Writing

MapLight Therapeutics•Burlington, MA

2d•Hybrid

About The Position

Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. 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.

Requirements

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.
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.

Nice To Haves

Experience managing vendors and contractors is a plus.

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.