Senior Manager/Associate Director, Regulatory Medical Writing, Immunology

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:
People Leader

All Job Posting Locations:
Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America

Job Description:

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.

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

We are searching for the best talent for a Senior Manager/Associate Director, Regulatory Medical Writing within our Integrated Data Analytics & Reporting (IDAR) business.

This role will support our Immunology Regulatory Medical Writing area. 

The position can be located at any of our following offices: High Wycombe (UK), Beerse (Belgium), Leiden (Netherlands), Allschwil (Switzerland), or Spring House/Raritan/Titusville (East Coast US).

Hybrid (3 days per week onsite) is strongly preferred.

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. 



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


* Writing or coordinating all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.


* Establishing and driving document timelines and strategies independently.


* Guiding or training cross-functional team members on processes and best practices.


* Proactively identifying and championing departmental process improvements.


* May lead cross-functional, cross-therapy area, or cross-J&J process improvement initiatives.


* Leading discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, Global Progr...