Senior Medical Writer- Clinical Focus
$116,000–$128,000 year
RemoteCanada or Massachusetts, United States
Job Summary
Senior Medical Writer - Clinical Focus: Lead authorship on regulatory documents across service lines, acting as project lead on smaller engagements and contributing to larger delivery teams. Interface with clients to guide document creation, lead teams to consensus, and develop submission-level documents (Clinical Study Reports, Investigator Brochures, protocols) within the drug development lifecycle. Possess strong Word/document management skills, the ability to synthesize data from multiple sources, and effectively persuade stakeholders. Demonstrate ability to build client relationships and contribute to an inclusive, globally distributed team; support regulatory writing efforts for oncology and rare disease projects and navigate health authority guidelines. The role emphasizes leadership in internal project teams, client-facing collaboration, and delivering compliant, publication-ready regulatory documents; salary range for US region is $116K–$128K with potential bonuses, and remote work is supported in a flexible, inclusive environment.
Required Qualifications
- Bachelor’s degree
- 3+ years regulatory writing experience or equivalent
- Experience in development of clinical documents (Clinical Study Reports, Investigator Brochures, protocols)
- Understanding of regulatory authority guidelines and requirements
Desired Qualifications
- Bachelor’s degree
- 3+ years regulatory writing experience or equivalent
- Experience leading internal project teams
- Experience developing submission-level documents (Clinical Study Reports, Investigator Brochures, protocols)
- Ability to interface with clients and lead teams to consensus
- Strong Microsoft Word skills and document management
- Knowledge of drug development lifecycle and health authority guidelines
- Ability to synthesize data across multiple sources
- CRM leadership and project-team coordination skills
- Strong written and verbal communication skills
- Experience in regulatory writing for clinical regulatory submissions
- Ability to persuade and present ideas effectively
- Equal opportunity employer awareness and inclusive collaboration mindset
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