Manager Clinical Affairs Medical Writing

Job Description - Manager Clinical Affairs Medical Writing (2506231484W)

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.

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/.

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:

1. 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).
2. Support establishment and execution of document timelines and strategies for sustaining efficient, ongoing processes to maintain compliance with EU regulatory requirements.
3. Conduct literature reviews and clinical data reviews to support preparation of regulatory documents and submissions.
4. Support cross-functional document planning and review through collaboration with colleagues across departments.
5. Lead document and process working groups, and lead product-level or submission-level writing teams within scope of role.
6. Ensure all regulatory documents meet regulatory requirements and guidelines (e.g., FDA, EMA) and company standards.
7. Stay updated with regulatory guidelines, industry trends, and best practices in regulatory medical writing.
8. Coach more junior writers on document and process planning and content.
9. Provide regulatory support and subject matter expertise as needed during audits or inspections related to post-market surveillance documents and processes.
10. Opportunities to expand writing and leadership capabilities in other areas of Clinical & Regulatory Affairs.

Qualifications:

1. Minimum of Bachelor’s degree (BS/BA) required; advanced degree (Masters, PhD or MD) and/or background in science/engineering preferred.
2. Minimum of 8 years relevant experience.
3. At least 5 years relevant scientific/med tech experience required; clinical research experience strongly preferred.
4. At least 4 years relevant medical writing experience required; experience in cardiovascular disease area strongly preferred.
5. 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.
6. Demonstrated ability to interpret, summarize, and present clinical, scientific, and statistical information in complex documents to ensure accuracy and clarity of content required.
7. Authoring experience with CERs, post-market surveillance plans, SSCPs, PMCFs strongly preferred.
8. Strong leadership and project management skills and cross-functional collaboration and relationship-building skills.
9. Excellent English oral and written communication with precise attention to detail.
10. Strong work ethic, self-motivated, team player with strong interpersonal skills.

This job posting is anticipated to close on February 17, 2025. 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 115000 to 197800. California Bay Area - The anticipated base pay range for this position is 141000 to 227700.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.

#LI-RP1