Principal Medical Writing Scientist

Job Description Janssen Research & Development, L.L.C., a division of Johnson & Johnsons Family of Companies is recruiting for a Principal Medical Writing Scientist to join the Medical Writing team to support our Immunology Therapeutic Area.

The position may be in Spring House, PA, Titusville, NJ, or Raritan, NJ in the United States, Beerse in Belgium or High Wycombe in the United Kingdom There is a possibility of Remote working for exceptional candidates.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease.

Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.

We bring together the best minds and pursue the most promising science.

We are Janssen.

We collaborate with the world for the health of everyone in it.

Learn more at www.janssen.com and follow us JanssenGlobal.

Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

Key Responsibilities: Prepare and finalize clinical documents such as, but not limited to, clinical study reports, investigators brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.

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 supervision.

Able to lead process working groups.

Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.

Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.

If a lead writer for a program: Be the 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.

Maintain and apply knowledge of the industry, company, and regulatory guidelines.

Qualifications Required: Bachelor’s degree is required, a Masters or PhD is preferred.

At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years of relevant medical writing experience.

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 under general supervision.

Strong attention to detail.

Strong oral and written communication skills.

Strong leadership skills, both in time management as well as in project/process management.

Able to resolve complex problems under supervision.

Demonstrate learning agility.

Able to build solid and positive relationships with cross‐functional team members.

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.