- Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) 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.
- Relevant professional experience actively writing regulatory documents.
- Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
- For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier [e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC]).
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed.
- Competency in the use of document management systems and review tools.
- Diploma/Master's/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 detail.
- Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.
- Applicants will work from one of our offices (Frankfurt, Germany or Cambridge, UK) and can work in an office-based, hybrid, or fully remote setting. Freelancers need not apply.
- Submission of documents in English:
- Cover letter specifying how you comply with the experience requirements
- CV
-
Medical Writer
vor 3 Wochen
PINK CARROTS Communications GmbH Frankfurt am Main, Deutschland**THINKING HEALTH DIFFERENTLY** · **Über PINK CARROTS** · **PINK CARROTS**ist eine inhabergeführte strategisch-kreative Kommunikationsagentur spezialisiert auf Health und Wellbeing. Das Team aus 50 Mitarbeitenden versteht Gesundheit als breites Dach. Und als weites Feld voller Mö ...
-
Medical Writer
vor 17 Stunden
Alcedis GmbH Frankfurt Am Main, DeutschlandAls Medical Writer unterstützt du die erfolgreiche Planung und Durchführung Projekten mit hoher Komplexität. Mit Engagement und Professionalität wirkst du bei der Abwicklung multizentrischer, internationaler klinischer Studien mit. Du bewältigst deine Aufgaben mit Eigeninitiative ...
-
Medical Writer
vor 2 Wochen
PINK CARROTS Communications GmbH GWA Frankfurt am Main, Deutschland**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 Laienzielgr ...
-
Junior Medical Writer
vor 1 Woche
DNA Frankfurt am Main, DeutschlandLocation: Frankfurt am Main oder Köln · Kommunikation im Gesundheitssektor ist herausfordernd, aber auch spannend. Hinzu kommen Internet, Social Media und das rasant wachsende Feld der E-Health-Technologien, die immer neue Themen und Blickwinkel mit sich bringen. Wofür wir uns mi ...
-
Medical Writer/scientific Advisor
vor 3 Tagen
GBG Forschungs GmbH Neu Isenburg, DeutschlandKlinische Forschung unter besseren Bedingungen - Wir vereinen akademisches Wissen und medizinisches Können mit wirtschaftlicher Flexibilität. · Die **GBG Forschungs GmbH** ist ein unabhängiges und akademisches Forschungsinstitut (ARO), welches klinische Studienprojekte zur Verbes ...
-
Principal Medical Writer
vor 2 Wochen
Trilogy Writing & Consulting GmbH Frankfurt am Main, DeutschlandAs a Principal 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 t ...
-
Senior Medical Writer
vor 2 Wochen
Trilogy Writing & Consulting GmbH Frankfurt am Main, DeutschlandAs 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 ...
-
Senior/principal Medical Writer
vor 2 Wochen
Trilogy Writing & Consulting Frankfurt am Main, DeutschlandTrilogy 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 deli ...
-
Senior Medical Writer, National Healthcare Team
vor 3 Wochen
Weber Shandwick Frankfurt am Main, Deutschland**Who are we?** · **_ Weber Shandwick_** is a leading global communications network - with earned ideas at the core, the agency deploys leading and emerging technologies to inform strategy, develop critical insights and heighten impact across sectors and specialty areas, includin ...
-
Medical Writer and Project Coordinator
vor 3 Tagen
Merck KGaA Darmstadt, DeutschlandWork Your Magic with us · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electro ...
-
Junior Berater
vor 1 Woche
FleishmanHillard Germany GmbH Frankfurt am Main, Deutschland**Dein Team**: · Ob OTC, RX, DiGA oder Medizintechnik - das Healthcare Team unterstützt internationale und nationale Kund:innen aus allen Bereichen des Gesundheitswesens. Du liebst Gesundheitsthemen und integrierte Kommunikationslösungen sind eine spannende Herausforderung für di ...
-
Berater (M/w/d) Healthcare Communications
vor 1 Woche
FleishmanHillard Germany GmbH Frankfurt am Main, Deutschland Ganztags**Dein Team**: · Ob OTC, RX, DiGA oder Medizintechnik - das Healthcare Team unterstützt internationale und nationale Kund:innen aus allen Bereichen des Gesundheitswesens. Du liebst Gesundheitsthemen und integrierte Kommunikationslösungen sind eine spannende Herausforderung für di ...
-
Sachbearbeiter in Qualitätswesen
vor 3 Wochen
Stanley Black & Decker Frankfurt Am Main, Deutschland**Job Title**: · Sachbearbeiter*in Qualitätswesen · **Location/s**: · Giessen DEU - Max-Eyth-Strasse · Stanley Black & Decker ist mit über Mitarbeitern der weltweit führende Anbieter für Werkzeuge und Zubehör, elektronische Sicherheitslösungen sowie Befestigungslösungen mit nachh ...
-
Resource Planning Coordinator
vor 1 Tag
Trilogy Writing & Consulting Frankfurt am Main, DeutschlandTrilogy Writing & Consulting GmbH is a specialized medical writing company that prepares regulatory documentation for the international pharmaceutical industry. We have a vacancy in either our Frankfurt, DE or Cambridge, UK offices for a: · **Resource Planning Coordinator (Full t ...
-
Director Of Medical Writing
vor 1 Woche
AL Solutions Mainz, Deutschland GanztagsWe are currently seeking a highly experienced and motivated individual to join our Global Biotech as the Director of Medical Writing. As the Director, you will be responsible for leading a team of medical writers and overseeing the development of high-quality scientific and regul ...
-
Translation Coordinator
vor 18 Stunden
Exocad Darmstadt, DeutschlandTo strengthen our Translation Team in Darmstadt, we are looking for you as a · Translation Coordinator (m/w/d) · (part time) · As Translation Coordinator, you will handle and monitor translation projects and work on improving the existing procedures. You will work closely toget ...
-
Koordinator:in Patientenbereich
vor 2 Wochen
Deutsche Sarkom-Stiftung Wölfersheim, Deutschland EmployeeDie Deutsche Sarkom-Stiftung ist eine "Mitmach-Organisation", in der · Patient:innen und Sarkom-Expert:innen gemeinsam und engagiert gegen · Sarkome kämpfen Hierbei widmet sich die gemeinnützige Stiftung der · dringend notwendigen, bisher zu wenig geförderten Sarkom-Forschung, · ...
Senior/Principal Medical Writer - Frankfurt, Deutschland - Trilogy Writing & Consulting
Beschreibung
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 writers are integral members of clinical development teams supporting the writing and coordinating of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop with us and your ideas will form our future together.
Tasks
As a Senior/Principal Medical Writer (m/w/d), you will:
Requirements
Candidates must have the following writing experience:
In addition to having the above writing experience, applicants must have:
Benefits
Remuneration will be relative to the level of experience, with all standard Trilogy benefits.
Only candidates who meet the following requirements will be considered:
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.
Collection and use of personal data in the application process: It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures, and are not forwarded to third parties. Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, and Trilogy Writing & Consulting, Inc. in the USA. By submitting your data with this application you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation. In the event of revocation, we will delete your personal data immediately.
Nutzer der Berufsbezeichnung Senior/Principal Medical Writer in Frankfurt am Main
-
Axel Schmidt
Profil