Senior Medical Writer - Regulatory Content Specialist

Harness your experience in regulatory content as a Senior Medical Writer within Amaris Consulting's hybrid work setting. Lead documentation efforts for global health authorities while shaping strategic regulatory submissions.

As part of this dynamic team, you will take charge of developing and executing regulatory content strategies throughout the product lifecycle. This includes managing clinical dossier preparations and ensuring compliance with global regulatory standards. By leading cross-functional collaborations, you will help resolve content-related challenges and maintain an organized workflow for submission documentation.

Key Responsibilities:

• Develop regulatory content strategies for global submissions

• Oversee clinical dossier and safety documentation preparation

• Review documents for clarity, consistency, and compliance

• Collaborate with teams to ensure timely delivery

• Mentor less experienced writers as needed

Requirements:

• Bachelor’s in a scientific discipline

• At least 5 years in regulatory writing roles

• Familiarity with ICH, GCP, GxP guidelines

• Proven track record in managing regulatory projects

• Proficiency in regulatory documentation tools

Enhance your regulatory expertise and support vital submissions at Amaris Consulting.
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