Manager Clinical Affairs Medical Writing

Company: Disability Solutions
Location: Danvers
Posted on: February 5, 2025

Job Description:

Johnson & Johnson's MedTech focused on cardiovascular health, is recruiting for a Manager, Medical Writing, Clinical & Regulatory Affairs. This position can be located in the US or Germany. Remote work options may be considered on a case-by-case basis and if approved by the Company.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.We are looking for a strong leader to support the development of regulatory documents and processes, with a focus on EU post-market surveillance requirements to drive better patient outcomes with the use of Abiomed products. The Manager, Medical Writing will oversee post-market surveillance activities within the Clinical and Regulatory Affairs department. The ideal candidate will be able to directly influence and maintain an ongoing, systematic, and controlled process to maintain compliance with appropriate regulations for Abiomed products.Primary Duties and Responsibilities:

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• Plan, prepare, and finalize regulatory documents focused on global post-market surveillance requirements, particularly US and EU; these include, but are not limited to, clinical evaluation plans and reports, post-market surveillance plans, summary of safety and clinical performance (SSCP), and post-market clinical follow-up plans and reports (PMCF)
• Support establishment and execution of document timelines and strategies for sustaining efficient, ongoing processes to maintain compliance with EU regulatory requirements
• Conduct literature reviews and clinical data reviews to support preparation of regulatory documents and submissions
• Support cross-functional document planning and review through collaboration with colleagues across departments
• Lead document and process working groups, and lead product-level or submission-level writing teams within scope of role
• Ensure all regulatory documents meet regulatory requirements and guidelines (e.g., FDA, EMA) and company standards
• Stay updated with regulatory guidelines, industry trends, and best practices in regulatory medical writing
• Coach more junior writers on document and process planning and content
• Provide regulatory support and subject matter expertise as needed during audits or inspections related to post-market surveillance documents and processes
• Opportunities to expand writing and leadership capabilities in other areas of Clinical & Regulatory Affairs\r\r

Keywords: Disability Solutions, Marthas Vineyard , Manager Clinical Affairs Medical Writing, Healthcare , Danvers, Massachusetts