Associate Director, X-TA Regulatory Medical Writing
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At Johnson & Johnson, we believe health is everything. Our focus is on treating, curing, and preventing the most devastating and complex diseases of our time. Through our expertise in Innovative Medicine and MedTech, we work across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact health for humanity.
Learn more at https://www.jnj.com
Position Overview
We are searching for a talented Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business to support one or more therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally, with opportunities in Europe and North America, and may be a hybrid (3 days in office, 2 remote) or fully remote role.
Responsibilities

Lead compound/submission/indication/disease area writing teams independently.
Supervise additional major responsibilities as required.
Drive cross‑functional, cross‑TA or cross‑J&J initiatives and collaborations.
Manage a subset of therapeutic areas and oversee program‑level/submission writing teams.
Prepare and finalize all types of clinical documents, taking a proactive lead role in content and scientific strategy.
Set objectives for team projects and tasks.
Guide and train cross‑functional team members on best practices; coach or mentor junior writers.
Identify and champion medical writing process improvements and internal standards.
Lead cross‑functional process improvement initiatives or large working groups.
Maintain and disseminate knowledge of industry, company, and regulatory guidelines to internal and external audiences.
As lead writer for a program:

Primary point of contact and champion for medical writing activities.
Plan and lead the writing group for the assigned program.
Function as a lead writer on any compound independently.
Lead discussions in medical writing and cross‑functional meetings.
Coordinate with senior cross‑functional colleagues and external partners.
Oversee the work of external contractors.


As a people manager:

Manage direct reports and set objectives.
Conduct regular development and performance discussions.
Ensure adherence to policies and templates.
Make hiring, onboarding, and talent development decisions.



Qualifications / Requirements

University/college degree in a scientific discipline; Masters or PhD preferred.
At least 10 years of relevant pharmaceutical or scientific experience, with a minimum of 8 years in medical writing.
For people managers, at least 2 years of people‑management experience.
Experience across multiple therapeutic areas preferred.
Strong attention to detail and communication skills; fluent English.
Expert project management and process improvement leadership.
Expert leadership skills (influencing, negotiation, conflict and change management).
Ability to delegate tasks to junior writers.
Proven ability to collaborate with business partners and customers.
Ability to interpret, summarize, and present statistical and medical information for complex documents.

Benefits

Base pay range for United States applicants: $137,000 to $235,750 (USD).
Annual performance bonus eligible under company guidelines.
Company‑sponsored benefits: medical, dental, vision, life insurance, short‑ and long‑term disability, business accident insurance, group legal insurance.
Consolidated retirement plan (pension) and savings plan (401(k)).
Time‑off benefits:

Vacation up to 120 hours per calendar year.
Sick time up to 40 hours per calendar year (56 hours in Washington State).
Holiday pay and floating holidays up to 13 days per calendar year.
Work, personal, and family time up to 40 hours per calendar year.


Additional benefits information: https://www.careers.jnj.com/employee-benefits

Equal Opportunity Employer
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.
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