Our client is looking to fill the role of Medical Writer. This role will be fully remote.
- 1 year duration / fully remote
Responsibilities:
- Writing based role within the Global Regulatory Affairs group
- Responsible for accurately authoring various regulatory documents including (clinical study reports, IBs, protocols, briefing packages, annual reports, integrated data summary reports and submission modules)
- Will be supporting the writing and preparation of documents submitted to regulatory agencies globally
- Serve as medical writing expert supporting various therapeutic area project teams
- Effectively manage writing activities across a variety of assigned projects
- Ensure continuous alignment to medical affairs strategy
Required Qualifications:
- Minimum of a BA/BS in Life Science; graduate degree preferred
- 4-7 years pharmaceutical/biotechnology experience (clinical research focus)
- Seeking BA/BS + 7 years of relevant experience or MS/PhD + 4 years of relevant experience
- Expertise in writing/developing clinical documents for global regulatory submissions
- Prior experience in a pharmaceutical, CRO or medical device environment
- Experience and knowledge of ICH and electronic submission guidelines for regulatory reporting
- Strong MS Office proficiency and electronic document management systems
Clinical Resource Network Distinction
CRN, a division of Solomon Page, offers a comprehensive benefits program for hourly employees. We pride ourselves on offering medical, dental, vision, 401(k), telehealth services, ESOP, and commuter benefits to our employees, including consultants - which sets us apart in the industries we serve.
About CRN
Founded in 2002, Clinical Resource Network (CRN), a division of Solomon Page, provides clinical research and talent solutions for pharmaceutical, biotech, and medical device companies. Focused on forming long-term relationships, services encompass contract staffing, project staffing, consultative services, and full-time placements. For more information, visit and connect with us on Facebook and LinkedIn .
Opportunity Awaits.