Principal Medical Writer- Clinical & Regulatory Strategic Communications
Merck
September 03, 2026
Remote
United States
Medical Affairs
In this role, the Principal Medical Writer will:
- Design, plan, author, edit, and review accurate, clear, high-quality clinical, regulatory, and/or public-facing documents reflecting medical writing best practices (e.g., lean writing, health literacy) and evolving regulatory requirements.
- Collaborate as a scientific contributor on cross-functional teams and support team/project leadership responsibilities.
- Apply critical thinking, problem-solving, and negotiation skills to implement innovative solutions across medical writing scope (documents, content, processes, timelines, tools) while navigating project dynamics.
- Provide program oversight by keeping project leads/management informed and escalating issues impacting timelines, quality, or compliance.
- Use medical writing tools and technology platforms effectively.
- Lead initiatives to improve medical writing processes and standards; may serve as an internal/external resource.
- Apply in-depth knowledge of clinical development, relevant regulations, disease areas, and company products.
- Provide scientific/operational mentorship to other medical writers.
- May manage direct reports (workload, professional development, performance).
Qualifications:
- Required: Bachelor’s degree or higher (health/scientific/relevant discipline) and at least 5 years of relevant medical writing or industry experience.
Required skills & experience:
- Manage complex writing projects in a deadline-driven environment; lead medical writers and/or cross-functional teams.
- Critically evaluate/interpret clinical data in line with regulatory requirements and industry guidelines.
- Demonstrate critical thinking, problem-solving, and ability to innovate/influence/drive change.
- Effective leadership including conflict resolution, negotiation, decision making, and navigating ambiguity.
- Excellent oral/written communication and presentation skills.
- Technical expertise with Microsoft Office/SharePoint and willingness to learn emerging technology.
- Independently prepare clinical regulatory documents (e.g., protocols, clinical study reports, submission documents) per regulatory requirements and guidelines.
Preferred skills/notes:
- Current employees/contingent workers apply via the provided internal links.
Application instruction:
- Apply via https://jobs.merck.com/us/en (application deadline per posting). Requisition ID: R415702.
- Design, plan, author, edit, and review accurate, clear, high-quality clinical, regulatory, and/or public-facing documents reflecting medical writing best practices (e.g., lean writing, health literacy) and evolving regulatory requirements.
- Collaborate as a scientific contributor on cross-functional teams and support team/project leadership responsibilities.
- Apply critical thinking, problem-solving, and negotiation skills to implement innovative solutions across medical writing scope (documents, content, processes, timelines, tools) while navigating project dynamics.
- Provide program oversight by keeping project leads/management informed and escalating issues impacting timelines, quality, or compliance.
- Use medical writing tools and technology platforms effectively.
- Lead initiatives to improve medical writing processes and standards; may serve as an internal/external resource.
- Apply in-depth knowledge of clinical development, relevant regulations, disease areas, and company products.
- Provide scientific/operational mentorship to other medical writers.
- May manage direct reports (workload, professional development, performance).
Qualifications:
- Required: Bachelor’s degree or higher (health/scientific/relevant discipline) and at least 5 years of relevant medical writing or industry experience.
Required skills & experience:
- Manage complex writing projects in a deadline-driven environment; lead medical writers and/or cross-functional teams.
- Critically evaluate/interpret clinical data in line with regulatory requirements and industry guidelines.
- Demonstrate critical thinking, problem-solving, and ability to innovate/influence/drive change.
- Effective leadership including conflict resolution, negotiation, decision making, and navigating ambiguity.
- Excellent oral/written communication and presentation skills.
- Technical expertise with Microsoft Office/SharePoint and willingness to learn emerging technology.
- Independently prepare clinical regulatory documents (e.g., protocols, clinical study reports, submission documents) per regulatory requirements and guidelines.
Preferred skills/notes:
- Current employees/contingent workers apply via the provided internal links.
Application instruction:
- Apply via https://jobs.merck.com/us/en (application deadline per posting). Requisition ID: R415702.