Principal Medical Writing Scientist (1 of 3)


At the Janssen PharmaceuticalCompanies of Johnson & Johnson, we are working to create a world withoutdisease. Transforming lives by finding new and better ways to prevent,intercept, treat and cure disease inspires us. We bring together the best mindsand pursue the most promising science. We are Janssen. We collaborate with theworld for the health of everyone in it. Learn more at follow us @JanssenGlobal. Janssen Pharmaceuticals, LLC is part of theJanssen Pharmaceutical Companies. Janssen Research & Developmentdiscovers and develops innovative medical solutions to address important unmetmedical needs in oncology, immunology, neuroscience, infectious diseases andvaccines, pulmonary hypertension, and cardiovascular and metabolic diseases. We are recruiting for a PrincipalMedical Writing Scientist to join the Medical Writing team to support ourOncology therapeutic area. The position may be located in Spring House, PA,Titusville, NJ, or Raritan, NJ in the United States, or High Wycombe in theUnited Kingdom. There is a possibility of Remote working for exceptionalcandidates. Are you ready to join our team? Then please read further! KeyResponsibilities: 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. 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 Education: University/college degree required. Mastersor PhD preferred. Experienceand Skills: We would value a colleague withthese qualities: At least 6 years of relevant pharmaceutical/scientific experience; at least 4 years of relevant medical writing experience (eg: Clinical protocols, Clinical study reports, Clinical summary documents, briefing documents, investigator's brochures and health authority responses) 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. Experience in Oncology Therapeutic Area is preferred 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. We will ensure that individuals withdisabilities are provided reasonable accommodation to participate in the jobapplication or interview process, to perform essential job functions, and toreceive other benefits and privileges of employment. Please contact us torequest accommodation. Johnson & Johnson is anAffirmative Action and Equal Opportunity Employer. All qualified applicantswill receive consideration for employment without regard to race, color,religion, sex, sexual orientation, gender identity, age, national origin, orprotected veteran status and will not be discriminated against on the basis ofdisability. Primary Location United States-Pennsylvania-Spring House- Other Locations United States-New Jersey-Raritan, United States-New Jersey-Titusville, United Kingdom-England-High Wycombe Organization Janssen Research & Development, LLC (6084) Job Function R&D Requisition ID 2005859635W

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