Senior Medical Writer

About the role

Our client, a leading organization in the pharmaceutical and biologic development industry, is seeking a Senior Medical Writer to join their team. As a Sr. Med Writer, you will be part of the Regulatory Affairs department supporting clinical development projects. The ideal candidate will demonstrate strong communication skills, attention to detail, and a proactive approach, which will align successfully in the organization.

What's the job?

• Serve as a primary author, providing strategic input and authoring regulatory documents supporting Phase 1-3 clinical drug development, including clinical study protocols, protocol amendments, and Clinical Study Reports (CSRs).
• Research, author, and/or edit complex clinical, scientific, and program-level regulatory documents such as Investigators Brochures (IBs), Investigational New Drug (IND) application documents, and Marketing Authorization Application (MAA) documents.
• Review documents prepared by junior writers and peers, offering guidance and mentorship on document development, regulatory requirements, and therapeutic area knowledge.
• Ensure all documents comply with quality standards, regulatory requirements, and client-specific standards, while developing best practices to optimize document quality and delivery.
• Support program management activities, including developing timelines, managing budgets, forecasts, and contract modifications, and addressing out-of-scope activities.

What's needed?

• Bachelor's degree in a scientific discipline or equivalent; advanced degrees preferred.
• Minimum of 5+ years of relevant experience in medical writing or regulatory document development.
• Experience working within the pharmaceutical or CRO industry is preferred.
• Additional qualifications in medical writing (e.g., AMWA, EMWA, RAC) are advantageous.
• Excellent data interpretation, medical writing, and editing skills, along with strong project management abilities.

Pay & schedule

• Location: 100% Remote (East coast preferred)
• Pay Range: $72.90/hr.
• Job Type: 6-month contract with the potential for hire/extension
• Schedule: M-F 40 hours/week (could be less depending on workload)

What's in it for me?

• Opportunity to work on impactful clinical development projects in a dynamic environment.
• Collaborate with a diverse and talented team of professionals.
• Engage in continuous learning and professional growth.
• Competitive pay rate aligned with industry standards.
• Work in a supportive environment that values innovation and excellence.
• Upon completion of waiting period, consultants are eligible for: Medical and Prescription Drug Plans, Dental Plan, Vision Plan, Health Savings Account, Health Flexible Spending Account, Dependent Care Flexible Spending Account, Supplemental Life Insurance, Short Term and Long Term Disability Insurance, Business Travel Insurance, 401(k) Plus Match, Weekly Pay.