Principal Medical Writer - Oncology

Merck & Co.

280d • $139,600 - $219,700 • Onsite

About The Position

The Principal Medical Writer is responsible for leading medical writing deliverables that support the clinical regulatory writing portfolio. The Principal Medical Writer independently leads and authors clinical regulatory documents (e.g., protocols, pivotal clinical study reports, clinical sections of submission) per company and regulatory requirements. They demonstrate expertise as a subject matter expert in document planning and authoring, and interpretation of data, using their own judgment and prior work experience. This role is recognized as a strong scientific contributor and works collaboratively on cross-functional teams while demonstrating an understanding of team and project leadership responsibilities. The Principal Medical Writer applies in-depth knowledge of clinical development, relevant regulations, disease areas, and company products, and demonstrates a developing understanding of the pharmaceutical industry beyond clinical research. They apply critical thinking, problem solving and negotiation skills to implement innovative solutions to complex challenges across the medical writing scope of work (e.g., documents, processes, tools) while navigating project team dynamics. Additionally, they demonstrate expertise in medical writing-specific tools and technology platforms and provide leadership in initiatives to improve medical writing processes and standards. They may also provide scientific and operational mentorship, coaching and/or project oversight to support other medical writers.

Requirements

• Degree in a scientific discipline (e.g., life sciences, pharmacy, medicine).
• Bachelor's degree with 7+ years, master's degree with 6+ years, or doctorate degree with 5+ years of relevant medical writing experience in the pharmaceutical and/or biotech industry.
• Ability to independently prepare a diverse set of clinical regulatory documents per regulatory requirements and industry guidelines.
• Ability to critically analyze and present clinical data clearly and objectively.
• Demonstrated critical thinking and problem-solving capabilities.
• Experience managing complex writing projects and leading project teams.
• Excellent oral and written communication and presentation skills.
• Technical expertise in office applications and shared document systems.

Responsibilities

• Independently lead and author clinical regulatory documents per company and regulatory requirements.
• Demonstrate expertise in document planning and authoring, and interpretation of data.
• Collaborate on cross-functional teams while understanding team and project leadership responsibilities.
• Apply in-depth knowledge of clinical development, relevant regulations, disease areas, and company products.
• Implement innovative solutions to complex challenges across the medical writing scope of work.
• Provide leadership in initiatives to improve medical writing processes and standards.
• Mentor and coach other medical writers.

Benefits

• Bonus eligibility
• Long term incentive if applicable
• Health care and other insurance benefits (for employee and family)
• Retirement benefits
• Paid holidays
• Vacation
• Sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree