Medical Writer

Our client is looking to fill the role of a Medical Writer. This position will be fully remote.

Responsibilities:

• Writing based role in the Global Regulatory Affairs department
• Responsible for writing and ensuring all communications are complete and scientifically accurate
• Accountable for preparation of accurate, timely regulatory documents submitted to regulatory agencies worldwide
• Responsible for managing writing activities across assigned projects to ensure medical writing strategy adherence
• Serve as medical writing expert and contribute to therapeutic project teams for clinical and regulatory submission documents
• Authors deliverables with consideration for regulatory, departmental, and quality standards (documents include protocols, clinical study reports, annual reports, Investigator’s Brochures [IBs], integrated data summary reports, Health Authority briefing packages and response documents, and submission summary modules)
• Have strong understand of medical writing practices, tools and systems to support clinical studies, to meet company objectives
• Ensure standardized practices are implemented across all therapeutic areas

Required Qualifications:

• Minimum of a BA/BS in Life Science; graduate degree preferred
• 4-7 years pharmaceutical/biotechnology experience related to clinical research
• Experienced writing/developing clinical documents to support global regulatory submissions
• Medical writing experience in Pharma, Biotech and/or CRO environment
• Medical device experience preferred but not required
• BA/BS degree – seeking 7+ years of writing experience or MS/PhD degree– seeking 4+ years of writing experience
• MS Office Proficiency
• Experience with electronic submission and ICH guidelines for regulatory reports

If you meet the required qualifications and are interested in this role, please apply today.

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.