Johnson and Johnson is hiring: Manager, Medical Writing, Clinical & Regulatory A

Job Function Medical Affairs Group Job Sub Function Medical Writing Job Category Professional All Job Posting Locations Danvers, Massachusetts, United States of America, Remote (US) Job Description At 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. About Cardiovascular Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients. We are searching for the best talent for a Manager, Medical Writing, Clinical & Regulatory Affairs. This is a remote role available in the continental USA. Purpose The Manager, Medical Writing, Clinical & Regulatory Affairs will lead & 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. You will be responsible for 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 Qualifications/Requirements Minimum of Bachelor's degree (BS/BA) required; advanced degree (Masters, PhD or MD) and/or background in science/engineering preferred At least 5 years relevant scientific/med tech experience required; clinical research experience strongly preferred At least 4 years relevant medical writing experience required; experience in cardiovascular disease area strongly preferred 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 CERs, post-market surveillance plans, SSCPs, PMCFs strongly preferred 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 Johnson & Johnson is an 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, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers internal employees contact AskGS to be directed to your accommodation resource. Base pay range $100,000 - $172,500 Additional Description for Pay Transparency Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits #J-18808-Ljbffr