Manager, Medical Writing

2 weeks ago

Irvine, United States Hydrogen Group Full time

Manager, Medical Writing

Remote, USA or On-Site/Hybrid (Irvine, CA)

Schedule: Standard Office Hours

Duration: 6-month contract

Pay Range: $52.00 - $57.00

Job Responsibilities:

In this role, you will manage and lead a variety of projects within the Medical Writing and Regulatory Affairs teams. Key responsibilities include:

- Planning, developing, and leading the completion of complex medical writing projects, with accountability for meeting project deliverables, timelines, and resolving issues with cross-functional partners (Regulatory Affairs, Quality, Clinical Project Managers, Clinical Data Management, Biostatistics, etc.).

- Acting as a technical expert to stakeholders, leading the implementation of corporate and departmental process updates and improvements (e.g., MDR compliance).

- Providing direction and guidance for smaller projects to execute medical writing initiatives, while mentoring team members and facilitating knowledge transfer.

- Representing the medical writing team in core meetings to develop reporting plans and regulatory submissions (U.S. and international) for clinical studies.

- Leading the identification, recommendation, and implementation of continuous process improvements related to medical writing.

- Performing other duties as assigned.

Essential Duties and Job Functions:

- Lead medical writing projects in a fast-paced environment, ensuring compliance with project deliverables and timelines.

- Provide mentorship to the medical writing team, guiding less experienced writers on best practices and industry standards.

- Serve as a representative in team meetings for the development of clinical and regulatory documents for submission in multiple regions (e.g., U.S., EU).

- Oversee the creation of technical documents, such as EU Clinical Evaluation Plans, CERs, Post-market Clinical Follow-up Plans and Reports, and other related documents.

- Perform thorough literature reviews using medical databases (e.g., PubMed, Medline) and summarize content for regulatory submissions.

- Provide leadership in process improvements and cross-functional collaboration to meet regulatory and clinical documentation standards.

Knowledge & Skills:

- Extensive experience in medical writing, specifically in the medical device or cardiovascular medical device industry.

- Expertise in authoring EU Clinical Evaluation Plans and Reports (CEP, CER) in compliance with applicable regulations and guidance (MDD, MDR, MDCG, etc.).

- Strong knowledge in conducting medical literature searches and evaluating content.

- Exceptional editing, proofreading, and document review skills.

- Proven leadership and team management experience, with the ability to coach and train others.

- Strong proficiency in Microsoft Office (Word, Excel, PowerPoint) and publication library software (e.g., EndNote).

- Excellent interpersonal, communication, and relationship management skills.

- High attention to detail with the ability to manage multiple competing priorities in a fast-paced environment.

- Solid understanding of biomedical statistics.

Education & Experience:

- Bachelor's degree in a related field with 8 years of relevant scientific experience, OR

- Advanced degree (Ph.D., MD, Sc.D., M.S., M.P.H.) with 6 years of relevant scientific experience.

- Experience as a medical writer in a medical device company, preferably in cardiovascular devices.

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