Senior Strategic Medical Writer - Remote

About the Role

We are seeking a Senior Strategic Medical Writer - Remote to join our dynamic team. In this role, you will be responsible for developing high-quality medical documents that support our clinical studies and regulatory submissions. As a Senior Strategic Medical Writer, you will collaborate with cross-functional teams to ensure that all documents meet the highest standards of scientific accuracy and compliance.

What You'll Do

• Develop and write clinical study protocols, clinical study reports, and other regulatory documents.
• Collaborate with clinical teams to ensure the accuracy and completeness of scientific content.
• Review and edit documents prepared by other team members to ensure clarity and compliance with ICH guidelines.
• Participate in project management activities, ensuring timelines are met and deliverables are of high quality.
• Engage in literature searches and summarize findings to support document development.
• Provide training and mentorship to junior writers and team members.
• Contribute to the development of governance frameworks and compliance policies.
• Utilize your expertise in medical terminology and therapeutic areas to enhance document quality.

Requirements

• Minimum of 5 years of experience in medical writing, preferably in the bio-pharmaceutical industry.
• Strong understanding of regulatory documents and compliance requirements.
• Proficiency in Microsoft Office Suite and document management systems.
• Excellent communication skills, both written and verbal.
• Ability to work independently and manage multiple projects simultaneously.
• Experience with clinical studies and scientific communication.
• Knowledge of ICH guidelines and Good Clinical Practice (GCP).
• Strong project management skills.

Nice to Have

• Experience with full stack software engineering and familiarity with programming languages such as TypeScript and JavaScript.
• Background in strategic planning and cost optimization.
• Experience in military campaign writing or similar fields.

What We Offer

• Comprehensive benefits package, including medical, dental, and vision insurance.
• 401(k) plan for eligible employees.
• Paid time off and flexible work arrangements.
• Participation in short-term incentive programs.
• Opportunities for professional development and career advancement.
• A collaborative and inclusive work environment.
• Remote work flexibility, allowing you to work from anywhere in the United States.