Senior Medical Writer

vor 2 Wochen

Frankfurt am Main, Deutschland Trilogy Writing & Consulting GmbH Vollzeit

As a Senior Medical Writer (m/w/d), you will: - Prepare a variety of clinical regulatory documents 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. - Several years of professional experience actively writing regulatory documents. - Worked as the lead writer on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs. - Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines. - Competency in the use of document management systems and review tools. In addition to having the above writing experience, applicants must have: - Diploma/Masters/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. - Submission of documents in English: - Cover letter specifying how you comply with the experience requirements listed above - CV - Trilogy Writing & Consulting 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.

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