Associate Director, Regulatory Medical Writing - Oncology

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

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Writing

Job Category:

Professional

All Job Posting Locations:

Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

About Innovative Medicine

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.

Learn more at https://www.jnj.com/innovative-medicine

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-010375

Canada - Requisition Number: R-011450 

Netherlands, Germany, Spain, France - Requisition Number: R-011453

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

This can be a hybrid (3 days in office and 2 remote) OR Remote role available in all countries listed above. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Remote work options may be considered on a case-by-case basis and if approved by the Company.

We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology.

Purpose:

• Able to function as a lead writer on any compound independently.

• Leads in setting functional tactics/strategy.

• Leads project-level strategy (eg, submission team, global program team, clinical team).

• May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority.

• Able to write and coordinate complex documents within and across TAs independently.

• Contributes to and champions internal standards, regulatory, and publishing guidelines.

• Contributes to and champions the improvement of internal systems, tools, and processes.

• Able to lead process working groups.

• Able to oversee the work of external contractors.

• May have additional major responsibility with supervision:

  • Cross-functional, cross-TA, or cross-J&J initiative/collaboration.

  • Larger organizational responsibility (eg, manage a subset of TA).

• If a people manager:

  • Manages a team of internal medical writers (direct reports).

  • Accountable for the quality of deliverables and compliance of direct reports.

  • Actively participates in resource management and hiring decisions.

You will be responsible for:

• Able to lead compound/submission/indication/disease area writing teams independently.

• Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.

• Writes or coordin