Senior/Principal Medical Writer - Italy Lazio

Senior/Principal Medical Writer - Italy
Roma
Lazio, Lazio

Trilogy Writing & Consulting, An Indegene Company, is currently looking to hire Senior/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 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 coordinating 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 see our website (https://trilogywriting.com/).

Applicants must live in Italy.

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 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. Candidates must have the following writing experience:

Relevant professional experience actively writing regulatory documents. Worked as the lead writer on at least>3 (Senior Medical Writer) or>5 (Principal Medical Writer) 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/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 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 remote from your home office in Italy. Freelancers need not apply. Submission of documents in English including CV and cover letter specifying how you comply with the experience requirements.

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