Johnson & Johnson
Manager, Clinical Affairs Medical Writing
Johnson & Johnson, Danvers, Massachusetts, us, 01923
Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Manager, Medical Writing, Clinical & Regulatory Affairs. This position may be located in the US or Europe. Remote work options may be considered on a case-by-case basis and if approved by the Company.
At Johnson & Johnson MedTech, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH), Surgical Robotics (OTTAVA), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.
Overview
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 Senior 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:
* 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, clinical development plans, post-market surveillance plans, periodic safety updates (PSUR), summary of safety and clinical performance (SSCP), post-market clinical follow-up plans and reports (PMCF), and trend reports* Establish document timelines and strategies for sustaining efficient, ongoing processes to maintain compliance with EU regulatory requirements* Lead 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., ICH, FDA, EMA) and company standards* Stay updated with regulatory guidelines, industry trends, and best practices in regulatory medical writing* Conduct literature reviews and clinical data reviews to support preparation of regulatory documents and submissions* 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
At Johnson & Johnson MedTech, we're changing the trajectory of health for humanity, using robotics to enhance healthcare providers' abilities and improve patients' diagnoses, treatments, and recovery times. Johnson & Johnson Robotics was established in 2020 with the integration of Auris Health, Verb Surgical, C-SATS, and Ethicon. It comprises three key med-tech platforms: Flexible Robotics (MONARCH), Surgical Robotics (OTTAVA), and Digital Solutions. Join our collaborative, rapidly growing teams in the San Francisco Bay Area (Redwood City and Santa Clara), Cincinnati, and Seattle. You'll collaborate on breakthrough medical technologies that unite multiple subject areas to build a connected digital ecosystem that advances medical professionals' skills and improves patient outcomes.
Overview
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 Senior 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:
* 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, clinical development plans, post-market surveillance plans, periodic safety updates (PSUR), summary of safety and clinical performance (SSCP), post-market clinical follow-up plans and reports (PMCF), and trend reports* Establish document timelines and strategies for sustaining efficient, ongoing processes to maintain compliance with EU regulatory requirements* Lead 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., ICH, FDA, EMA) and company standards* Stay updated with regulatory guidelines, industry trends, and best practices in regulatory medical writing* Conduct literature reviews and clinical data reviews to support preparation of regulatory documents and submissions* 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