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.



  • Zürich, Zürich, Schweiz Johnson & Johnson Vollzeit

    About the RoleWe 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...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    Job DescriptionAbout the RoleWe are seeking an experienced Immunology Medical Lead to join our team in Zurich, Switzerland. As a key member of our Global Medical Affairs team, you will be responsible for leading the medical strategy in Immunology portfolio and selected pipeline assets focused on the EUCAN region.Key ResponsibilitiesLead the medical strategy...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    Job DescriptionAbout the RoleWe are seeking an experienced Medical Lead to join our team in Zurich, Switzerland. As a Medical Lead for Immunology Portfolio in EUCAN, you will be responsible for leading the medical strategy and operations for our Immunology portfolio in the EUCAN region.Key ResponsibilitiesLead the medical strategy and operations for...


  • Zürich, Zürich, Schweiz UCB Group Vollzeit

    About the RoleWe are seeking a highly motivated and experienced Key Account Manager Immunology to join our local commercial operations team in Eastern Switzerland.As a Key Account Manager Immunology, you will be responsible for informing healthcare professionals about the benefits of our innovative products and establishing impactful projects for our...


  • Zürich, Zürich, Schweiz UCB Group Vollzeit

    About the RoleWe are seeking a highly motivated and experienced Key Account Manager Immunology to join our local commercial operations team in Eastern Switzerland.Key ResponsibilitiesInform office- and hospital-based health care professionals about the benefits of our innovative products and establish impactful projects for our solutions and therapy...


  • Zürich, Zürich, Schweiz UCB Group Vollzeit

    About the RoleWe are seeking a highly motivated and experienced Key Account Manager Immunology to join our local commercial operations team in Eastern Switzerland.Key ResponsibilitiesInform and engage office- and hospital-based healthcare professionals about the benefits of our innovative products and establish impactful projects for our solutions and...


  • Zürich, Zürich, Schweiz Amaris Consulting Vollzeit

    Job OverviewWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Amaris Consulting. As a key member of our client's team, you will be responsible for ensuring compliance with regulatory requirements and ensuring the smooth operation of our client's business.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    Job Summary Takeda is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements for device and drug-device combination products. Key Responsibilities Develop and implement regulatory strategies for device and drug-device...

  • Medical Specialist

    vor 1 Monat


    Zürich, Zürich, Schweiz oprandi & partner ag Vollzeit

    We are a leading international firm, OpRandi & Partner AG, offering a comprehensive network of national and international companies in the healthcare sector. Our team provides expert support in finding new career opportunities that value your work and personality.We are seeking a highly skilled Medical Specialist / Medical Specialist for Switzerland to join...

  • Medical Specialist

    vor 3 Wochen


    Zürich, Zürich, Schweiz oprandi & partner ag Vollzeit

    We are a leading international firm, OpRandi & Partner AG, offering a comprehensive network of national and international companies in the healthcare sector. Our team provides expert support in finding new career opportunities that value your work and personality.We are seeking a medical specialist with a strong background in their field, looking for a new...


  • Zürich, Zürich, Schweiz SIX Vollzeit

    Regulatory SpecialistAbout the Role:SIX is seeking a highly skilled Regulatory Specialist to join our team. As a key member of our regulatory team, you will be responsible for monitoring regulatory changes in CCP regulations across EU, ES, CH, and UK, and translating them into actionable strategies for SIX Clearing.Key Responsibilities:Stay up-to-date with...


  • Zürich, Zürich, Schweiz Company 81 - Manulife Data Services Inc. Vollzeit

    About Company 81 - Manulife Data Services Inc.Company 81 - Manulife Data Services Inc. is a leading provider of innovative data solutions, helping individuals and businesses make informed decisions. With a strong focus on data integrity and accuracy, we strive to deliver exceptional results.Job SummaryWe are seeking a highly skilled Medical Summary...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking an experienced Associate Director to lead our Device and Drug-Device Combinations EU and Global Markets team. As a key member of our Regulatory Affairs department, you will be responsible for developing and implementing innovative regulatory strategies for our combination product portfolio.Key ResponsibilitiesDevelop and implement...


  • Zürich, Zürich, Schweiz Company 81 - Manulife Data Services Inc. Vollzeit

    About the RoleWe are seeking a highly skilled Medical Summary Specialist to join our team at Company 81 - Manulife Data Services Inc.Key Responsibilities:Provide accurate and comprehensive summaries of medical documents, including APS reports, laboratory findings, and diagnostic studies.Interpret medical information and identify relevant details for...


  • Zürich, Zürich, Schweiz Company 81 - Manulife Data Services Inc. Vollzeit

    About the RoleWe are seeking a highly skilled Medical Summary Specialist to join our team at Company 81 - Manulife Data Services Inc.Key Responsibilities:Provide accurate and reliable medical summaries to support business decisions, utilizing a pre-defined template format.Interpret diagnostic tests, laboratory findings, and medical reports to identify...


  • Zürich, Zürich, Schweiz Daiichi Sankyo Europe Vollzeit

    Join Our Team as a Field Medical Advisor SBDWe are seeking a highly qualified Field Medical Advisor SBD to join our team at Daiichi Sankyo Europe. As a Field Medical Advisor SBD, you will play a crucial role in developing and executing medical strategies to support our business goals.Key Responsibilities:Develop and execute medical strategic plans in...


  • Zürich, Zürich, Schweiz Company 81 - Manulife Data Services Inc. Vollzeit

    About the Role:We are seeking a highly skilled Medical Summary Specialist to join our team at Company 81 - Manulife Data Services Inc. The successful candidate will be responsible for summarizing APS documents, interpreting diagnostic tests, and providing high-quality summaries to our underwriters.Key Responsibilities:Summarize APS documents using a...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Takeda. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and guidelines for clinical trials in the EUCAN and GEM regions.Key ResponsibilitiesDevelop and implement operational plans for clinical trial...


  • Zürich, Zürich, Schweiz Takeda Vollzeit

    Job SummaryTakeda is seeking a highly skilled Regulatory Affairs Specialist to join our team in Zurich, Switzerland. As a Regulatory Affairs Specialist, you will be responsible for the development and implementation of innovative integral combination product regulatory strategies pertaining to the development, registration, commercialization and life cycle...


  • Zürich, Zürich, Schweiz J Safra Sarasin Vollzeit

    Your RoleWe are seeking a highly skilled Regulatory Transformation Specialist to join our Business and Regulatory Development department at J Safra Sarasin.As a key member of our project team, you will support various regulatory financial market related initiatives, such as the implementation of EMIR Refit requirements and optimization of MiFIR or FMIA...