Senior Regulatory Medical Writer

4 giorni fa

Roma, Lazio, Italia Johnson & Johnson A tempo pieno
Job Title: Senior Regulatory Medical Writer

Johnson & Johnson is seeking a highly skilled Senior Regulatory Medical Writer to join our Immunology team. As a key member of our Regulatory Medical Writing team, you will be responsible for preparing and finalizing clinical documents, leading cross-functional document planning and review meetings, and interacting with peer writers and colleagues from other departments.

Key Responsibilities:
  • Prepare and finalize clinical documents, including 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, interacting with peer writers and colleagues from other departments.
  • Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.
  • Establish document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
  • 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.
Qualifications:
  • A minimum of a Bachelor's or equivalent University/College degree is required.
  • Advanced degree (Masters, PhD) preferred.
  • A minimum of 6 years of relevant pharmaceutical/scientific experience is required.
  • A minimum of 4 years of relevant medical writing experience is required.
  • Authoring experience with investigator brochures, clinical study protocols, and clinical study reports.
  • Experience with common technical document summaries is preferred.
  • Strong leadership skills, both in time management and in project/process management is required.
  • Must have strong attention to detail.
  • Must have strong oral and written communication skills.
  • Must be able to resolve complex problems under supervision.
  • The ability to build solid and positive relationships with cross-functional team members.
  • The 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 is required.
What We Offer:
  • Competitive salary range: $116,700 to $187,795 (San Francisco Bay Area, CA) or $102,000 to $163,300 (all other U.S. locations).
  • Annual performance bonus.
  • Eligibility for employee benefit programs, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Eligibility for the Company's consolidated retirement plan (pension) and savings plan (401(k)).
  • Time off benefits, including vacation, sick time, holiday pay, and work, personal and family time.

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.

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