Associate Director, Regulatory Medical Writing Job at Johnson & Johnson in Rarit

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/

Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, pulmonary hypertension, and retinal disease.

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

This position will lead medical writing (MW) activities in the gastrointestinal disease area, and will lead a team of internal writers who can be deployed across J&J Immunology programs. This role will report directly to the Regulatory Medical Writing Delivery Unit Head, Immunology.

* Is the primary point of contact for MW activities for the cross-functional team in the disease area.

* Writes or coordinates all types of clinical and regulatory documents, taking a proactive lead role in driving content and scientific strategy.

* Establishes and drives document timelines and strategies independently.

* Guides or trains cross-functional team members on processes and best practices; coaches or mentors more junior writers.

* Proactively identifies and champions departmental process improvements. May develop and present best practices or innovations to internal or external audiences.

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

* Leads discussions in MW and cross-functional meetings as appropriate (eg, submission team meetings, study team meetings, clinical team meetings).

* Maintains and disseminates knowledge of industry, company, and regulatory guidelines.

* Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.

As a people manager:

* Leads and is accountable for direct reports.

* Ensures team members adhere to established policies, procedural documents, and templates.

* Participates in hiring, onboarding, conducting career and talent development discussions, goal-setting, performance reviews, and compensation planning.