Senior Medical Writer — Regulatory & Submissions Lead

Caraway Therapeutics, Inc.; Rahway (NJ); On-site; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

401(k)

Paid holidays

Vacation and sick days

Job summary

The Clinical and Regulatory Strategic Communications (CRSC) team at Merck & Co., Inc. in Rahway, NJ, develops regulated content for development programs and data sharing, emphasizing accuracy, compliance, and health literacy.

The role focuses on preparing clinical regulatory documents (protocols, CSRs, ICFs) and plain-language materials, collaborating with cross-functional teams, and applying writing best practices to meet tight timelines and evolving regulatory standards.

Qualifications

• 3+ years of relevant medical writing or industry experience.
• Demonstrated ability to prepare clinical regulatory documents and plain-language materials.

Responsibilities

• Lead or participate in cross-functional teams for document development.
• Ensure alignment with regulatory requirements and quality standards.
• Manage timelines and escalate issues that affect quality or timelines.

Skills

Project management

Clinical data interpretation

Critical thinking

Conflict resolution

Adaptability

Written communication

Microsoft Office

SharePoint

Education

Bachelor's degree in health/science

Tools

Microsoft Office

SharePoint

Job description

The Clinical and Regulatory Strategic Communications (CRSC) team at Merck & Co., Inc. in Rahway, NJ, develops regulated content for development programs and data sharing, emphasizing accuracy, compliance, and health literacy.

The role focuses on preparing clinical regulatory documents (protocols, CSRs, ICFs) and plain-language materials, collaborating with cross-functional teams, and applying writing best practices to meet tight timelines and evolving regulatory standards.