Immunology Regulatory Medical Writing Specialist

vor 3 Wochen

Zürich, Zürich, Schweiz Johnson & Johnson Vollzeit
About the Role

We are seeking a highly skilled Senior Regulatory Medical Writer to join our Immunology team at Johnson & Johnson. As a key member of our 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, ensuring timely and high-quality delivery of documents.
  • Interact with peer writers and colleagues from other departments, fostering strong relationships and effective communication.
  • 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.
Requirements
  • 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 compensation and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • The chance to work on complex and challenging projects.
  • A comprehensive benefits package, including medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
  • Eligibility to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
  • Generous time off benefits, including vacation, sick time, holiday pay, and work, personal and family time.
About Johnson & Johnson

Johnson & Johnson is a global healthcare leader dedicated to helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. Our Research & Development team discovers and develops innovative medical solutions to address important unmet medical needs in various therapeutic areas.

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