Overview
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
We are searching for the best talent for an Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business. This role will support one or more of our therapeutic areas within the X-TA Regulatory Medical Writing area. This position is open globally and may be in Europe or North America. Remote work options may be considered on a case-by-case basis and if approved by the Company.
You Will Be Responsible For
* Leading compound / submission / indication / disease area writing teams independently.
* May have additional major responsibility with supervision.
* Cross-functional, cross-TA, or cross-J&J initiative / collaboration.
* Larger organizational responsibility (e.g., manage a subset of TA).
* Preparing and finalizing all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Working with a high level of independence and taking a lead role with respect to timing, scheduling, and tracking.
* Leading program-level / submission writing teams independently.
* Directly leading or setting objectives for others on team projects and tasks.
* Guiding or training cross‑functional team members on processes, best practices; coach or mentor more junior writers.
* Proactively identifying, contributing to and championing Medical Writing process improvements, internal standards, regulatory, and publishing guidelines, internal systems, tools, and processes.
* Leading cross‑functional / cross‑TA, cross‑J&J process improvement initiatives, or other large process working groups.
* Developing, maintaining and disseminating knowledge of industry, company, and regulatory guidelines to internal and external audiences.
* If a lead writer for a program: primary point of contact and champion for Medical Writing activities for the clinical team; responsible for planning and leading the writing group for assigned program; able to function as a lead writer on any compound independently; leading discussions in Medical Writing and cross‑functional meetings; interacting with senior cross‑functional colleagues and external partners to strengthen coordination between departments; able to oversee the work of external contractors.
* As a people manager: manage direct reports in Medical Writing; set objectives for individual team members; regularly meets with direct reports to ensure development, project alignment, and issue resolution; ensure adherence to policies, procedures, and templates; hiring decisions, onboarding, career development, goal setting and performance discussions.
Qualifications / Requirements
* University / college degree in a scientific discipline is required. Masters or PhD preferred.
* At least 10 years of relevant pharmaceutical / scientific experience; at least 8 years of relevant Medical Writing experience is required.
* If a people manager, at least 2 years of people management experience.
* Multiple therapeutic area experience preferred.
* Strong attention to detail; excellent oral and written communication skills; fluent written and spoken English.
* Expert project management skills and leadership in process improvement.
* Strong leadership skills (influencing, negotiating, assertiveness, initiative, conflict management, change management) and people management abilities.
* Ability to delegate to junior writers and collaborate with key business partners and customers.
* Ability to interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Compensation & Benefits
The anticipated base pay range for this position is $137,000 to $235,750 (USD) for United States applicants. The Company offers performance-based compensation, eligibility for an annual bonus, and a comprehensive benefits program including medical, dental, vision, life insurance, disability coverage, and a 401(k) plan where applicable. Employees may participate in company-provided time-off benefits; details vary by location.
Employees are eligible for the Company’s time off benefits, and general information on company benefits can be found at the employer’s careers portal. The compensation and benefits information applies to candidates hired in the United States; in other countries, compensation and benefits follow local market practices. 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.
Seniority level
* Not Applicable
Employment type
* Full-time
Job function
* Education and Training
* Industries
Johnson & Johnson is committed to diversity and inclusion and welcomes applicants from all backgrounds.
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