Principal Medical Writing Scientist, Oncology Early Development

At Janssen, we never stop working toward a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart.

We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com

Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team are recruiting for a Principal Medical Writing Scientist to support our Oncology Early Development therapeutic area. This position is open globally and may be located in Europe (eg, United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy, Poland, Bulgaria or Switzerland), North America (eg, Spring House, PA, Raritan, NJ, Titusville, NJ, or Canada), or other countries. Remote work options may be considered on a case-by-case basis and if approved by the company.

Are you ready to join our team? Then please read further!

Key Responsibilities :

• Prepare and finalize clinical documents such as, but not limited to, first-in-human study protocols, protocol amendments, initial investigator's brochures, health authority responses, general investigation plans, briefing documents, and pediatric 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.