Manager Clinical Affairs Medical Writing

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:

• 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

• 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

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.

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 and/or eligible dependents may be 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.

• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year
• Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

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