Senior Medical Writer

vor 3 Wochen


Frankfurt am Main, Deutschland Trilogy Writing and Consulting Vollzeit

As a Senior Medical Writer (m/w/d), you will:

- Prepare a variety of clinical regulatory documents as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate.
- Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients.
- Be responsible for providing document-specific advice to clients.
- Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
- Project manage the timelines and review cycles of your documents.
- Work in the client’s regulatory document management systems.
- Several years of professional experience actively writing regulatory documents.
- Worked as the lead writer on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs.
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- Competency in the use of document management systems and review tools.

In addition to having the above writing experience, applicants must have:

- Diploma/Masters/Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
- Fluent written and spoken English skills.
- An appreciation for a well-written document and an eye for details.
- Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.

Remuneration will be relative to the level of experience, with all standard Trilogy benefits.
- Submission of documents in English:

- Cover letter specifying how you comply with the experience requirements listed above
- CV
- Trilogy Writing & Consulting complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state/provincial, and local law. We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work._



  • Frankfurt am Main, Deutschland Trilogy Writing & Consulting Vollzeit

    Trilogy Writing & Consulting is currently looking to hire Senior and Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our...


  • Frankfurt, Deutschland Trilogy Writing & Consulting Vollzeit

    Trilogy Writing & Consulting is currently looking to hire Senior and Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our...


  • Frankfurt, Deutschland Trilogy Writing & Consulting Vollzeit

    Trilogy Writing & Consulting is currently looking to hire Senior and Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing. Our...

  • Medical Writer

    vor 1 Monat


    Frankfurt am Main, Deutschland PINK CARROTS Communications GmbH GWA Vollzeit

    **DU BEI PINK CARROTS***: - Du arbeitest dich schnell in neue Indikationen ein und berätst Kund*innen auf Augenhöhe. - Du erstellst Konzepte und Inhalte für wissenschaftliche und werbliche Formate (u.a. Folder, eDetailer, Slidedecks, Websites) für Fach - und Laienzielgruppen. - Du besuchst Fachkongresse und übernimmst die Nachberichterstattung. - Du...


  • Frankfurt am Main, Deutschland subrosa health group Vollzeit

    Director Medical Affairs Germany (m/f/d) On behalf of our exclusive client, we are searching for a passionate Director Medical Affairs Germany for the Do you want to contribute to improving the health of millions of people worldwide who rely on innovative therapies? Director Medical Affairs Germany (m/w/d) Defining strategy, setting goals, and ensuring...

  • Technical Writer

    vor 1 Monat


    Frankfurt am Main, Deutschland Kofax Vollzeit

    Management and staff in Kofax’s Technical Communications job family help the company to ensure that its products and technology solutions are positioned for maximum success through the provision of expert and targeted user documentation and materials. The position of Technical Writer is a core, entry-level departmental role and appointees are expected to...


  • Frankfurt am Main, Deutschland subrosa health group Vollzeit

    Director Medical Affairs Germany (m/f/d) On behalf of our exclusive client, we are searching for a passionate Director Medical Affairs Germany for the Immunology/Dermatology sector. Do you want to contribute to improving the health of millions of people worldwide who rely on innovative therapies? Then this could be the perfect opportunity for you. ...


  • Frankfurt, Deutschland Grifols Vollzeit

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and...


  • Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    We are seeking a talented and experienced **Senior Expert Requirements Engineering - Digital Ecosystem **(M/F/d)** to join our team. In this role, you will take end-to-end responsibility to drive the success of our industry-leading medical product portfolio. Fresenius Medical Care is dedicated to creating a future worth living for patients, worldwide, every...


  • Hattersheim am Main, Deutschland CSL Vollzeit

    Join our dynamic Medical Affairs team in Hattersheim, greater Frankfurt area, and become an essential part of our mission as we prepare to launch an innovative treatment for Hereditary Angioedema (HAE). We're seeking a passionate and experienced (Senior) Medical Affairs Manager – Rare Diseases (m/f/x) (Fulltime / permanent) The Opportunity As...


  • Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    **Main tasks**: **_ Material compliance:_**: - Evaluation of raw materials as well as finished products concerning regulatory EHS-requirements on substances and materials (REACH, POP, MDR, CLP, Packaging Directive etc.) - Contact person to external supplier concerning the before mentioned requirements - Creation and maintenance of dossiers for Nordic eco...


  • Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    This is an outstanding opportunity to join Fresenius Medical Care newly formed Digital Services and Solutions Group as Product Owner. This role will be located in Bad Homburg or Berlin. In this role you own the digital product, its digital journeys, and the user experience. You will collaborate with prospective users and clients to understand and anticipate...


  • Frankfurt am Main, Deutschland KAIKO GmbH Vollzeit

    **Responsibility**: Work in a small team of dedicated professionals. Write gameplay code according to specifications from designers and lead programmers Write systems code to power gameplay systems specified by designers and lead programmers Design editable data for Entity placement Mentor Junior programmers. **Qualifications**: - Very experienced in C /...


  • Frankfurt am Main, Deutschland State Street Vollzeit

    Who we are looking for- Für unseren Bereich Funds Accounting - Investment Administration Insourcing Services bei der State Street Bank International GmbH in Frankfurt suchen wir ab sofort einen Senior Funds Accountant (m/w/d) - Senior Associate - Why this role is important to us - The team you will be joining is a part of State Street Global Services...


  • Frankfurt, Deutschland Disruptive DataTech Vollzeit

    Job Brief: Client: Media and EntertainmentRelocation package for EU citizens.We are seeking a Senior Java Developer with extensive Java experience, including proficiency in Spring, JPA, Hibernate, and Kafka. Your role will involve developing high-performance, low-latency, and highly scalable recommendation systems on a cloud platform.Have a keen interest in...


  • Ludwigshafen am Rhein, Deutschland AbbVie Vollzeit

    **Company Description** - Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets,...


  • Frankfurt, Deutschland Optimus Search Vollzeit

    Are you passionate about improving people's wellbeing through your work? With a global reach that extends across 50 countries worldwide, my client is a leading medical technology company creating medical devices and laboratory equipment for a variety of needs across the healthcare space. The job is exciting because of the team's mission: improving access to...


  • Frankfurt Am Main, Deutschland Fresenius Medical Care Vollzeit

    Your assignments: - Drive In-center downstream marketing annual budgeting to ensure adequate resourcing of marketing plans to support regional sales forecasts and strategic initiatives. - Coordinate with Product Management to optimize the commercialization strategy and execution of In-center products and services. - Closely partner with Commercial...


  • Frankfurt Am Main, Deutschland Lilly Vollzeit

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...


  • Frankfurt am Main, Hessen, Deutschland Cpl Vollzeit

    Our client is a Global Leader in fund services, asset services and corporate governance that is looking to hire Admin Assistant to join their growing team in Frankfurt.Your Role:Handling of day-to-day basic administration work related to clients closely collaborating with the senior team in FrankfurtProviding administrative and analytical support directly to...