Senior Manager, Medical Writing
Senior Manager, Medical Writing – Greater Boston, MA (Hybrid) / Remote-US
Our client, an innovative global biopharma organization, is searching for a Senior Manager, Medical Writing to lead clinical and regulatory document development across multiple therapeutic programs. This is not a role at GQR; we are acting on behalf of our client.
What You’ll Do
* Own authorship and lifecycle management of protocols, CSRs, IBs, and regulatory sections.
* Liaise with Biostats, Clinical Ops, Regulatory, and other functions to ensure crystal-clear, data-driven messaging.
* Guide and QC work outsourced to contract writers and CRO partners.
* Run simultaneous writing projects, upholding timelines and quality benchmarks.
* Establish templates, style guides, and writing best practices.
* Contribute strategic insight to overall clinical development and submission planning.
What You’ll Bring
* 5 + years’ clinical medical-writing experience with strong protocol & CSR expertise.
* Deep understanding of ICH, GCP, and global regulatory expectations.
* Proficiency with document-management platforms (e.g., Veeva Vault) and MS Office.
* Excellent cross-functional communication skills; ability to influence without authority.
* Neuroscience/psychiatry experience a plus.
* Hybrid (3 days/week on-site) preferred; outstanding fully-remote U.S. candidates considered.
* Target base salary around $170k
Seniority level
* Mid-Senior level
Employment type
* Contract
Job function
* Writing/Editing
Industries
* Biotechnology Research and Pharmaceutical Manufacturing
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