Porto, Portugal · Remote OK
Trilogy Writing & Consulting, an Indegene Company, is currently hiring Associate Principal and Principal Medical Writers (F, M or D) in the UK and Europe to support our growing company in producing regulatory documentati…
Skills: Regulatory writing, Clinical study protocols, Clinical study reports, CTD format, Investigator brochures
Porto, Portugal • Remote OK
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The lead writer will prepare complex clinical regulatory documents such as protocols, reports, and summaries while collaborating with global teams. They are also responsible for project management, budget oversight, and providing document-specific advice to clients.
Candidates must have at least 5 years of experience in regulatory writing, specifically as a lead writer on CTD documents. A Bachelor's degree in science or pharmacy is required, along with in-depth knowledge of regulatory guidance like ICH, FDA, and EMA.
Trilogy Writing & Consulting, an Indegene Company, is currently hiring Associate Principal and Principal Medical Writers (F, M or D) in the UK and Europe to 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 (www.trilogywriting.com).
Trilogy offers the following:
As an Associate Principal/Principal Medical Writer, you will:
Candidates must have the following:
In addition to having the above writing experience, applicants must have:
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.
Masters of Medical Writing
At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their clinical documents to meet timelines, with a readability that reduces the time for review and approval. We have been helping pharmaceutical companies and clinical research organizations of all sizes, worldwide, to streamline their documentation processes for over 18 years – either as support on a one-off document or the entire clinical development program. We provide our clients with a constructive advice on their projects: we guide our clients’ teams through the writing process and ask them the right questions in order to produce documents that communicate effectively. Our writers are trained to understand that our job is not to produce a data dump: it is to think about the data available and work with the team to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing clinical documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval. Trilogy currently has more than 80 writers, who are located in Trilogy’s 3 offices: Frankfurt in Germany (HQ), Cambridge in the UK, and Durham, North Carolina in the US.
Offices: Falkensteiner Strasse 77, Frankfurt, 60322, DE · Merlin Place, Milton Road, Cambridge, Cambridgeshire CB4 0DP, GB · 200 Meredith Dr, Durham, North Carolina 27713, US
Masters of Medical Writing
At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their clinical documents to meet timelines, with a readability that reduces the time for review and approval. We have been helping pharmaceutical companies and clinical research organizations of all sizes, worldwide, to streamline their documentation processes for over 18 years – either as support on a one-off document or the entire clinical development program. We provide our clients with a constructive advice on their projects: we guide our clients’ teams through the writing process and ask them the right questions in order to produce documents that communicate effectively. Our writers are trained to understand that our job is not to produce a data dump: it is to think about the data available and work with the team to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing clinical documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval. Trilogy currently has more than 80 writers, who are located in Trilogy’s 3 offices: Frankfurt in Germany (HQ), Cambridge in the UK, and Durham, North Carolina in the US.
Offices: Falkensteiner Strasse 77, Frankfurt, 60322, DE · Merlin Place, Milton Road, Cambridge, Cambridgeshire CB4 0DP, GB · 200 Meredith Dr, Durham, North Carolina 27713, US
