Manager Regulatory Medical Writing.

Janssen Pharmaceutica NV, a member of Johnson & Johnson’s Family of Companies, is recruiting for a Manager Regulatory Medical Writing to support the Infectious Diseases and Vaccines therapeutic area.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

This position can be located in Belgium (Beerse), the Netherlands (Leiden), the U.K. (High Wycombe), Switzerland (Bern), Germany (Neuss), or the U.S. (Titusville, NJ, Raritan, NJ, Spring House, PA). Remote work options may be considered on a case-by-case basis and if approved by the Company.

Key Responsibilities

• Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigator’s brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. Take a lead role with respect to content and scientific strategy.
• Lead cross-functional document planning and review meetings. Interact with peer writers and colleagues from other departments. Able to lead program-level or submission writing teams with general supervision. Able to lead process working groups.
• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed. You may lead the work of other medical writers, external contractors, and document specialists supporting a project.
• Work with a high level of independence, responsible for establishing document timelines and strategies in accordance with internal processes, with minimal guidance.
• If a lead writer for a program:
• Primary point of contact and champion for medical writing activities for the clinical team. Responsible for planning, setting strategy, and leading writing group for assigned program.
• Champion medical writing standard processes and provide recommendations for departmental process improvements.
• Maintain and disseminate knowledge of the industry, company, and regulatory guidelines. May represent medical writing in industry standards working groups.
• If a people manager:
• Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
• Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal‐setting and performance discussions.

Education

Qualifications

• University/college degree required. Masters or PhD preferred.

Experience And Skills

We would value a colleague with these qualities:

• At least 8 years of relevant pharmaceutical/scientific experience; at least 6 years of relevant medical writing experience.
• If a people manager, preferably up to 2 years of people management experience.
• Strong oral and written communication skills.
• Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
• Attention to detail.
• Able to resolve complex problems under general supervision.
• Demonstrate learning agility.
• Able to build and maintain solid and positive relationships with cross‐functional team members.
• Strong leadership skills, both in time management as well as in project/process management.

For candidates in the U.S. only: At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment in the U.S. must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

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.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Ready to be part of something great? Don’t forget to apply. We want YOU!

Primary Location

Belgium-Antwerp-Beerse-

Other Locations

North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Switzerland-Berne-Bern, North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House, Europe/Middle East/Africa-United Kingdom-England-High Wycombe, Europe/Middle East/Africa-Germany-North Rhine Westphalia-Rhein-Kreis Neuss

Organization

Janssen Pharmaceutica N.V. (7555)

Job Function

R&D

Requisition ID

2206018000W