AssociatePrincipal Medical Writer
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Monthly Salary:
Posted on:
4 days ago
Vacancies:
1 Vacancy
Job Summary
Senior/Principal Medical Writer Remote/Hybrid/In Office - UK
Trilogy Writing & Consulting AnIndegeneCompanyis currently looking to hire Senior/PrincipalMedical Writers (f/w/d) 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 coordinationof 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.
Applicants must live in one of the following countries: The UK Germany Italy Ireland or Portugal.
As a Senior/Principal Medical Writeryou 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 asappropriate.
- Ensure that all documents are produced according to agreed timelinesmonitorand manage project budgets adhere to relevant SOPs and meet the requirements of Trilogy as well as the companys clients.
- Be responsible forprovidingdocument-specific advice to clients.
- Oversee and coordinate other writers and QC specialistsassistingon 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 2different typesof CTD dossiers (i.e.full new chemical entity application a variation a generic dossier anorphan 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 ofthe documentsand coordinating review cycles meetings and project timelines.
- For the Principal Medical Writer levelabilityand 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 proactivelyparticipatingon a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.
- Must live in the UK Germany Italy Ireland or Portugal.
Remuneration will berelativeto the level of experience with all standard Trilogy benefits.
Only candidates who meet the following requirements will be considered:
- Applicants will work fully remotelyorhybrid remotelyfromour UK office in Cambridge. Freelancers need not apply.
- Submission of documents in English.
- Cover letter specifying how youcomply with the experience requirements listed above.
- CV
Trilogy Writing & Consulting AnIndegeneCompanycomplies withall laws respecting equal employment opportunity and does not discriminate against applicantswith regard toany protected characteristic as defined by federal state/provincial and local law. Wepassionately 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 Trilogyareprotected against unauthorized access and manipulation by technical and organizationalmeasures andare notforwardedto 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. Bysubmittingyour data with thisapplicationyou 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 ofrevocation we willdeleteyour personal dataimmediately.
Required Experience:
Staff 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.
