Senior/Principal Medical Writer - Remote - Europe/UK
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Trilogy Writing & Consulting an Indegene Company is currently looking to hire Senior/Principal Medical Writers to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy you will be part of a team that provides a service that goes beyond just writing. Our writers are integral parts of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As a growing company there is room to develop with us and your ideas will form our future together. For further insight into who we are and what we do please look at our website ( must be eligible to work in the UK Germany Italy Ireland or Portugal.
As a Senior/Principal Medical Writer you will:
- 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 companys 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 clients regulatory document management systems.
The candidate must have the following writing experience:
- Several years of professional experienceactively 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.
In addition to having the above writing experience applicants must have:
- Diploma/Masters/Bachelors 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.
Only candidates who meet the following requirements will be considered:
- Applicants will work fully remotely based in Portugal. Freelancers need not apply.
- Submission of documents in English:
- Cover letter specifying how you comply with the experience requirements listed above
- CV
Trilogy Writing & Consulting an Indegene Company 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 the USA. By submitting your data with this application you consent to its use for this purpose within can revoke this consent at any time without needing to give a reason by informing us of your revocation under In the event of revocation we will delete your personal data immediately.
Required Experience:
Senior IC
Key Skills
- Clinical Research
- Adobe Acrobat
- FDA Regulations
- Technical Writing
- Biotechnology
- Clinical Development
- Clinical Trials
- Microsoft Powerpoint
- Research Experience
- Document Management Systems
- Word Processing
- Writing Skills
About Company
Partners for Medical Writing - Trilogy Writing & Consulting GmbH - providing all necessary regulatory documentation in support of your clinical development.
