Associate Medical Writer.

Vor 3 Tagen


Zug, Schweiz PSI Vollzeit

Job Description

Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing Critically assesses, interprets, and summarizes data from clinical studies Reviews scientific literature pertinent to medical writing activities Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing) Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks Collaborates with the Process Improvement narrative automation team to develop patient safety narratives

Qualifications

College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities. Minimum 2 years of corresponding industry experience working with clinical documentation and data Prior pharmaceutical, biotechnology, or contract research organization experience Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents Basic knowledge of electronic Common Technical Document (eCTD) requirements

Additional Information



  • Zug, Schweiz TN Switzerland Vollzeit

    Social network you want to login/join with:ResponsibilitiesWrites, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation.Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives.Collects and tracks documents for CSR...


  • Zug, Schweiz Blueprint Medicines Vollzeit

    **Associate Director, International Medical Affairs Operations** Location(s): Zug, Switzerland Level of position: Associate Director Position type: office-based Reporting Line: VP Medical Affairs, International ***How will your role help us transform hope into reality?** ***This position reports into the VP of International Medical Affairs and will...


  • Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

    Caring for the world, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the...


  • Zug, Schweiz Blueprint Medicines Vollzeit

    **Medical Affairs Operations Coordinator - Contract** Location(s): Zug, Switzerland Position type: office-based, in alignment with BlueFlex model* Reporting Line: The position reports to the Associate Director, International Medical Affairs **How will your role help us transform hope into reality?** This position reports into the Associate Director...


  • Zug, Schweiz Galderma Vollzeit

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...


  • Zug, Schweiz Meditrial Europe Ltd. Vollzeit

    Meditrial is a full-service digital research organization with a foundation in clinical trial research, education, regulatory and market access. Meditrial has been leading the medical tech industry by delivering unparalleled outcomes for innovators. Our successful track record supporting medical device and biotechnology companies in all phases of clinical...


  • Zug, Schweiz Galderma Vollzeit

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the leading company solely dedicated to skin and advancing the future of dermatology. We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all,...


  • Zug, Schweiz Johnson & Johnson Family of Companies Vollzeit

    **Johnson & Johnson Vision** is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients see better through their world leading **ACUVUE®** Brand Contact Lenses. In 2017, J&J expanded into cataract surgery, laser refractive surgery (LASIK) and...


  • Zug, Schweiz Panda International Vollzeit

    QA Associate This position will support the Global data collection automatization activities to improve CMO and suppliers data collection and KPI process establishment. The role reports into the Senior Director of External Quality and sits within a growing External Quality Operations team that is part of our expanding Global Center of Excellence focused on...


  • Zug, Schweiz Meditrial Europe Ltd. Vollzeit

    Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals. Since 2008, Meditrial delivers...


  • Zug, Schweiz Johnson & Johnson Vollzeit

    Johnson & Johnson MedTech Companies are committed to reaching more patients and creating a better quality of life. The J&J Companies have been advancing patient care for more than a century. With an unparalleled range of products and services, programs, and research and development in surgical technologies, orthopedics, cardiovascular and specialty...

  • Associate Director

    Vor 6 Tagen


    Zug, Schweiz NonStop Consulting Vollzeit

    If you are currently performing the role for a Clinical Trial Manager or Clinical Operations Manager and looking to step into a Director position this is your chance! My Client who is an international company is looking for a Associate Director - Clinical Operations to join their team in the office in Zug, Switzerland on a 12 month contract. They are focused...


  • Zug, Schweiz Johnson & Johnson Vollzeit

    Janssen Global Services, L.L.C. (JGS), one of the Johnson & Johnson family of companies, is recruiting for an Associate Director, Global Pricing Analytics within the Global Commercial Strategy Organization (GCSO) located in Zug, Switzerland, Beerse, Belgium or Raritan, NJ Caring for the world, one person at a time has inspired and united the people of...


  • Zug, Schweiz Deciphera Pharmaceuticals Vollzeit

    Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative...


  • Zug, Schweiz Implantica Vollzeit

    **About Implantica Group Implantica is a medtech group dedicated to bringing advanced technology into the body. Implantica’s lead product, RefluxStop, is a CE-marked implant for the prevention of gastroesophageal reflux that will potentially create a paradigm shift in anti-reflux treatment as supported by successful clinical trial results. Implantica also...


  • Zug, Schweiz Seagen Vollzeit

    Seagen is a global multi-product biotechnology company that develops and commercializes innovative therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. In addition to four marketed products, we are...


  • Zug, Schweiz SHL Medical AG Vollzeit

    **Job Overview** **Main Responsibilities** - Prosecute office action responses, including responses to office actions before the European Patent Office (EPO) as well as providing detailed guidance to non-EPO associates for the preparation of responses to office actions also in other jurisdictions - Work autonomously to manage a portfolio of cases and...


  • Zug, Schweiz Blueprint Medicines Vollzeit

    **Location(s)**:**Zug, Switzerland **Level of position**:**Associate Director **Position type**:**office-based, in alignment with BlueFlex model* **Reporting Line**:**VP, Head of International Finance **How will your role help us transform hope into reality?** Our company has attracted some of the most brilliant and accomplished talents in the industry...


  • Zug, Schweiz Blueprint Medicines Vollzeit

    Location(s): Zug, SwitzerlandLevel of position: Associate DirectorPosition type: office-based, in alignment with BlueFlex model*Reporting Line: VP, Head of International FinanceHow will your role help us transform hope into reality?Our company has attracted some of the most brilliant and accomplished talents in the industry and is now looking for an...


  • Zug, Schweiz Kiniksa Pharmaceuticals Vollzeit

    The Senior Clinical Project Manager/Associate Director, Clinical Operations will provide operational expertise within the Research and Development function to ensure timely initiation, execution and reporting of clinical trials in accordance with ICH/GCP and all applicable requirements (including local regulations) to support licensure of products in the...