Full-Time Medical Writer

Position Overview

The Manager, Medical Writing leads the planning, development, and execution of complex medical writing projects that support regulatory submissions and compliance across U.S. and international markets. This role serves as a key collaborator with cross-functional teams and provides strategic and technical leadership to advance high-quality, regulatory-compliant documentation.

Key Responsibilities

• Lead and manage complex medical writing projects, ensuring timely, compliant, and high-quality deliverables.
• Collaborate cross-functionally with Regulatory Affairs, Quality, Clinical Project Management, Biostatistics, and Data Management to ensure project success.
• Serve as a subject matter expert in medical writing standards, regulatory requirements, and process improvement initiatives (e.g., MDR compliance).
• Mentor and guide medical writing team members, providing coaching and knowledge transfer for ongoing professional growth.
• Represent the function in core team meetings to develop reporting plans and support global regulatory submissions.
• Drive process innovation, identifying and implementing continuous improvements in medical writing practices and tools.
• Author, review, and edit key regulatory and clinical documents, ensuring clarity, consistency, and compliance with applicable guidance.
• Contribute to strategic planning for document development, review cycles, and submission readiness.

Required Qualifications

• Bachelors degree in a related scientific or technical field with 8+ years of relevant experience, OR
• Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) with 6+ years of relevant scientific experience.

Preferred Qualifications

• Experience as a medical writer within a medical device company (cardiovascular device experience preferred).
• Demonstrated success authoring and managing:
  • EU Clinical Evaluation Plans and Reports (CEP, CER) per MDR and MEDDEV standards.
  • Post-Market Clinical Follow-up Plans and Reports.
  • Summary of Safety and Clinical Performance (SSCP).
  • Additional regulatory and clinical documentation as required.
• Proficiency in medical literature research (PubMed, Medline) and synthesis of scientific data.
• Ability to engage with cross-functional teams to discuss and interpret complex technical topics.
• Proven ability to coach, mentor, and lead medical writing professionals.
• Advanced proficiency in Microsoft Office, EndNote, and database tools (e.g., Medline, PubMed).
• Exceptional editing, writing, and communication skills with high attention to detail.
• Strong project management skills with the ability to prioritize multiple deliverables in a fast-paced environment.
• Working knowledge of biomedical statistics and clinical study documentation standards.
• Ability to influence and collaborate across organizational levels and manage stakeholder expectations.

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