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

MSD•Rahway, NJ

10d•$117,000 - $184,200

About The Position

The Senior Medical Writer works in the Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO), which creates high-quality regulated content supporting the development pipeline and data sharing. The department partners strategically to ensure quality and compliance with applicable laws while applying health literacy principles to 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 documents, such as informed consent forms, clinical trial registration 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 materials consistent with medical writing best practices and regulatory requirements. The Senior Medical Writer contributes scientifically and collaborates on document-specific cross-functional teams, demonstrates an understanding of team and project leadership, and uses critical thinking, problem solving, and negotiation to address challenges involving documents, content, processes, timelines, and tools. The position keeps medical writing project leads and/or management informed and escalates issues that could affect timelines, quality, or compliance. It also applies knowledge of medical writing tools and technology platforms, contributes to process and standards improvements, and applies knowledge of clinical development, regulations, disease areas, and company products. The role may support departmental needs such as onboarding or mentoring writers and may manage direct reports, including workload, professional development, and performance management. The position is based primarily in Rahway, New Jersey. The role has a day shift, requires 10% travel, and does not offer relocation or visa sponsorship. The position is regular employee status. The listed primary-location salary range is $117,000–$184,200, with eligibility for an annual bonus and long-term incentive, if applicable.

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.
Strong oral and written communication and presentation skills.
Technical expertise in commonly used office applications, such as Microsoft Office Suite, and shared document systems, such as SharePoint, and willingness to learn and adapt to emerging technology.
Knowledge of medical writing, regulatory compliance, regulatory documents and submissions, ICH GCP guidelines, process improvement, project management, adaptability, and ethical standards.

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, and written communication skills.

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 principles.
Contribute scientifically and collaborate on document-specific cross-functional teams; demonstrate understanding of team and project leadership responsibilities.
Apply critical thinking, problem-solving, and negotiation skills to address challenges involving documents, content, processes, timelines, and tools.
Keep the medical writing project lead and/or management informed and escalate issues that could affect timelines, quality, or compliance.
Use medical writing-specific tools and technology platforms.
Participate in or lead initiatives to improve medical writing processes and standards, and serve as a resource when appropriate.
Apply knowledge of clinical development, relevant regulations, disease areas, and company products.
May assist with departmental needs, including orienting new team members and mentoring less experienced writers.
May manage direct reports, including their workload, professional development, and performance management.
Manage multiple writing projects in a deadline-driven environment and lead teams of medical writers and/or cross-functional team members.