Mgr, Clinical Affairs Medical Writing Job at Johnson and Johnson ...
Johnson and Johnson - Danvers, MA, United States, 01923
Work at Johnson and Johnson
Overview
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Overview
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. Learn more at https://www.jnj.com
Job Function:
Medical Affairs Group
Job Sub Function:
Medical Writing
Job Category:
Professional
All Job Posting Locations:
Aurora, Illinois, United States, Danvers, Massachusetts, United States of America, Durham, North Carolina, United States, New Brunswick, New Jersey, United States of America, St. Paul, Minnesota, United States, Tampa, Florida, United States of America
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. Learn more at https://www.jnj.com.
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.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
Remote work options may be considered on a case-by-case basis and if approved by the Company.
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, 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.
- Minimum of Bachelor's degree (BS/BA) required; advanced degree (Masters, PhD or MD) and/or background in science/engineering preferred.
- Minimum of 8 years relevant experience.
- 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) required.
- Demonstrated ability to interpret, summarize, and present clinical, scientific, and statistical information in complex documents to ensure accuracy and clarity of content required.
- 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.
Compensation and Benefits:
The anticipated base pay range for this position is: $115,000- $197,000. Additional information can be found through the link below. http://www.careers.jnj.com/employee-benefits. #J-18808-Ljbffr