What are the responsibilities and job description for the Regulatory Medical Writer position at Clinical Resource Network (CRN)?
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 https://www.solomonpage.com/crn and connect with us on Facebook and LinkedIn.
Opportunity Awaits.
