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:

• Own planning, preparation, and finalization of 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
• Own cross-functional document planning and review through collaboration with colleagues across departments
• Own 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 and oversee 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
• Partner with Regulatory Affairs in strategizing on regulatory pathways required for approved and new investigational devices and for indication expansion globally
• Cross-collaboration with other departments in the Medical Office

QUALIFICATIONS

Education:

• Advanced degree (Masters, PhD/PharmD or MD) in a science/engineering discipline

Required Experience and Skills:

• At least 8 years relevant scientific/med tech experience
• At least 4 years relevant medical writing experience
• Strong knowledge of FDA and EU MDR regulations and post-market requirements as defined in 21 CFR 814.82 Subpart E and Chapter VII of Regulation EU 2017/745 (MDR)
• Demonstrated ability to interpret, summarize, and present clinical, scientific, and statistical information in complex documents to ensure accuracy and clarity of content
• Authoring experience with CER’s, post-market surveillance plans, PSUR’s, SSCP’s

Preferred Experience and Skills:

• Clinical research experience
• Strong leadership and project management skills and cross-functional collaboration and relationship-building skills
• Excellent English oral and written communication with precise attention to detail
• Strong work ethic, self-motivated, team player with strong interpersonal skills

Other:

• This position can be based in the United States or Europe. Remote work is a possibility based on individual basis.

This job posting is anticipated to close on 08.13.2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.
The anticipated base pay range for this position is [$198,500] to [$228,000]
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.
For additional general information on company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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• Own planning, preparation, and finalization of 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
• Own cross-functional document planning and review through collaboration with colleagues across departments
• Own 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 and oversee 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
• Partner with Regulatory Affairs in strategizing on regulatory pathways required for approved and new investigational devices and for indication expansion globally
• Cross-collaboration with other departments in the Medical Offic