Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)

MSD • Rahway, NJ

8d

About The Position

The Senior Medical Writer works within the Clinical and Regulatory Strategic Communications (CRSC) department of Global Clinical Trial Operations. CRSC creates high-quality regulated content to support the development pipeline and enable data sharing, serving as a strategic partner for compliance with applicable laws and the use of health-literacy principles in public-facing materials.

The role independently prepares clinical regulatory documents, such as protocols, clinical study reports, participant narratives, and investigator’s brochures, and/or public-facing materials, such as informed consent forms, clinical trial registrations and results postings, and plain-language summaries. The writer applies in-depth knowledge of document design, planning, authoring, editing, and review to produce accurate, clear, high-quality content aligned with medical-writing best practices and applicable company and regulatory requirements.

The Senior Medical Writer contributes scientifically and collaborates on document-specific cross-functional teams, applying critical thinking, problem solving, and negotiation to address challenges involving documents, content, processes, timelines, and tools. The role keeps the medical writing project lead and/or management informed and escalates issues that could affect timelines, quality, or compliance. It also applies knowledge of clinical development, relevant regulations, disease areas, company products, and medical-writing tools and technology platforms. The writer may participate in or lead process and standards improvement initiatives, support onboarding or mentoring, and may manage direct reports, including their workload, professional development, and performance.

Requirements

• Bachelor’s degree, preferably in a health, scientific, or relevant discipline such as life sciences, pharmacy, medicine, or public health.
• At least 3 years of relevant medical-writing or industry experience.
• Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Ability to interpret clinical data clearly and objectively, in accordance with regulatory requirements and industry guidelines, with minimal supervision.
• Demonstrated critical-thinking and problem-solving capabilities.
• Experience with conflict resolution and negotiation in cross-functional teams.
• Ability to adapt to changing project needs and unexpected workload demands to help the team succeed.
• Strong oral and written communication and presentation skills.
• Technical expertise with commonly used office applications, such as Microsoft Office Suite, and shared document systems, such as SharePoint; willingness to learn and adapt to emerging technology.

Nice To Haves

• Experience independently preparing a subset of clinical regulatory documents, such as protocols, clinical study reports, participant narratives, or investigator’s brochures, in accordance with regulatory requirements and industry guidelines.
• Mentorship.
• Teamwork.
• Time management.
• Written communication.

Responsibilities

• Independently prepare clinical regulatory and/or public-facing documents in accordance with company and evolving regulatory requirements.
• Design, plan, author, edit, and review accurate, clear, high-quality documents using medical-writing best practices, including lean writing and health literacy.
• Contribute scientifically and collaborate on document-specific cross-functional teams.
• Apply critical thinking, problem-solving, and negotiation skills to address challenges across documents, content, processes, timelines, and tools.
• Keep the medical writing project lead and/or management informed and escalate issues that may affect timelines, quality, or compliance.
• Use medical-writing tools and technology platforms.
• Participate in or lead initiatives to improve medical-writing processes and standards, and serve as an internal or external resource when appropriate.
• Apply knowledge of clinical development, relevant regulations, disease areas, and company products.
• Support departmental needs such as orienting new team members or mentoring less experienced writers.
• May manage direct reports, including workload, professional development, and performance management.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior