Principal / Associate Principal Medical Writer

Visa Hunt; Viseu; Presencial; EUR 60 000 - 80 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Annual bonus

Paid time off

Benefits package

EMWA membership paid

Yoga sessions

Resumo da oferta

Trilogy Writing & Consulting, an Indegene Company, is hiring Associate Principal/Principal Medical Writers to lead regulatory documentation projects across CTD formats in the UK and Europe. You will coordinate multi-disciplinary teams and ensure timely delivery of Clinical Study Protocols, CSR, Investigator Brochures, and related documents.

We value 5+ years of regulatory writing experience, leadership capability, and strong knowledge of ICH, FDA, and EMA guidelines.

Qualificações

• Lead writer for regulatory documents across CTD formats.
• At least 5 years actively writing regulatory documents.

Responsabilidades

• Lead and coordinate writers and QC specialists on regulatory documents.
• Manage timelines, budgets, and review cycles for documents.
• Provide document-specific advice to clients and oversee CTD submissions.
• Collaborate with client authoring teams in a global setting.

Conhecimentos

Regulatory writing

CTD documents

Project management

Team coordination

English fluency

Formação académica

Bachelor's degree in science/pharmacy

Ferramentas

Document management systems

Descrição da oferta de emprego

Trilogy Writing & Consulting, an Indegene Company, is currently hiring Associate Principal and Principal Medical Writers(F, M or D) in the UK and Europeto support our growing company in producing 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 coordination 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. For further insight into who we are and what we do, please explore our website (). Trilogy offers the following: Competitive base salary. Annual bonus opportunity. A generous allowance of paid time off. Comprehensive benefit plans aligned withyour region.

Full EMWA membership and annual conference attendance paid for by Trilogy. Continuous personal and professional development opportunities. Free weekly yoga sessions. Other fun and exciting events that encourage team bonding and development.

As an Associate Principal/Principal Medical Writer, you will: Function as a lead writer to 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) 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 forproviding document-specific advice to clients. Oversee and coordinate other writers and QC specialists assistingwith documents under your responsibility. Project manage the timelines and review cycles of your documents.

Work in the client's regulatory document management systems. Candidates must have the following: At least 5 years of experience of actively writing regulatory documents;
experience as a lead writer on CTD documents is mandatory. Must have worked as the lead writer on several key regulatory documents such as: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.

Must have experience as the lead writerwith multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight. Must be able to manage multiple projects simultaneously. Must have in-depth working knowledge of the relevant regulatory guidance (e.G. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance. Experience in multiple therapeutic areas to have confidence to work in these areas without lead-in time.

Advanced understanding of and ability to apply statistical, regulatory, and medical communication concepts are needed to independently write complex regulatory documents without supervision. Competency in the use of document management systems and review tools. In addition to having the above writing experience, applicants must have: A minimum of a 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. 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.

Principal / Associate Principal Medical Writer Portalegre, Portuguese Republic, PT