Senior Medical Writer - Regulatory & Clinical Leader

Merck; Rahway (NJ); Sur place; USD 117 000 - 184 000; Plein temps

Résumé du poste

Merck is seeking an experienced Clinical and Regulatory Medical Writer to support the CRSC within Global Clinical Trial Operations. You will lead document design, planning, authoring, editing, and review to ensure high-quality, regulatory-compliant materials across clinical and public-facing documents.

You will collaborate with cross-functional teams, apply critical thinking to solve challenges, and mentor junior writers while navigating timelines and regulatory requirements in a dynamic

Qualifications

• Bachelor’s degree in health, science, or related field and 3+ years of medical writing experience.
• Ability to interpret clinical data in line with regulatory requirements and guidelines.
• Experience managing multiple writing projects and leading cross-functional teams.

Responsabilités

• Lead and mentor medical writing teams and plan timelines across projects.
• Ensure regulatory and quality standards are met in documents and processes.
• Collaborate with cross-functional teams to drive content strategy and resolution of issues.
• Apply problem-solving and negotiation skills to keep timelines and quality on track.

Connaissances

Medical writing

Cross-functional collaboration

Project leadership

Regulatory guidance

Critical thinking

Negotiation

Communication skills

Office tools

Formation

Bachelor’s degree in health or life sciences

Outils

Microsoft Office Suite

SharePoint

Description du poste

Merck is seeking an experienced Clinical and Regulatory Medical Writer to support the CRSC within Global Clinical Trial Operations. You will lead document design, planning, authoring, editing, and review to ensure high-quality, regulatory-compliant materials across clinical and public-facing documents.

You will collaborate with cross-functional teams, apply critical thinking to solve challenges, and mentor junior writers while navigating timelines and regulatory requirements in a dynamic