Johnson & Johnson is hiring: Associate Director, Regulatory Medical Writing in G

Job Description - Associate Director, Regulatory Medical Writing (2406226472W)

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.

We are recruiting for an Associate Director to join the Regulatory Medical Writing team to support the Immunology therapeutic area. The position may be located in Spring House, PA or Raritan or Titusville, NJ, in the US; High Wycombe in the UK; or other global locations. Remote work options may also be considered on a case-by-case basis and if approved by the business.

Are you ready to join our team? Then please read further!

Key Responsibilities

• Lead medical writing (MW) activities in the gastrointestinal disease area and lead a team of internal writers across J&J Immunology programs.
• Be the primary point of contact for MW activities for the cross-functional team in the disease area.
• Write or coordinate all types of clinical and regulatory documents, taking a proactive lead role in driving content and scientific strategy.
• Establish and drive document timelines and strategies independently.
• Guide or train cross-functional team members on processes and best practices; coach or mentor more junior writers.
• Proactively identify and champion departmental process improvements; develop and present best practices or innovations to internal or external audiences.
• Lead cross-functional, cross-therapeutic area, or cross-J&J process improvement initiatives.
• Lead discussions in MW and cross-functional meetings as appropriate.
• Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
• Interact with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

• Lead and be accountable for direct reports.
• Ensure team members adhere to established policies, procedural documents, and templates.
• Participate in hiring, onboarding, conducting career and talent development discussions, goal-setting, performance reviews, and compensation planning.

Qualifications

Education:

• University/college degree required. Masters or PhD preferred.

Experience and Skills:

• At least 10 years of relevant pharmaceutical/scientific experience, including at least 8 years of relevant regulatory medical writing experience, is required.
• At least 2 years of people management experience is required.
• Excellent oral and written communication skills.
• Experience in project management and process improvement is required.
• Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
• Ability to serve as the liaison between team members and senior leadership within the immunology therapeutic area is required.
• Ability to build and maintain solid and productive relationships with cross-functional team members is required.

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.

The anticipated base pay range for this position is 137000 to 235750.

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.

Primary Location

NA-US-Pennsylvania-Spring House

Other Locations

Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, NA-United States, NA-US-New Jersey-Raritan, NA-US-New Jersey-Titusville