Lavori attuali relativi a Senior/Principal Medical Writer - Roma, Lazio - Trilogy Writing and Consulting
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Senior Medical Writing Consultant
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Senior Medical Writing Consultant
2 settimane fa
Roma, Lazio, Italia MMS Holdings Inc. A tempo pienoMMS Holdings Inc. is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.We are seeking a highly skilled Medical Writer to join our team. The ideal candidate will have a strong background in...
Senior/Principal Medical Writer
2 mesi fa
Trilogy Writing and Consulting is seeking a highly skilled Senior/Principal Medical Writer to join our team of regulatory documentation specialists. As a key member of our clinical development team, you will be responsible for producing high-quality regulatory documents for the international pharmaceutical industry.
Key Responsibilities- Document Preparation: Prepare a variety of clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, and scientific publications, as the lead writer in collaboration with client authoring teams.
- Project Management: 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 and our clients.
- Client Support: Provide document-specific advice to clients and oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
- Regulatory Affairs: Work in client regulatory document management systems and project manage the timelines and review cycles of your documents.
- Writing Experience: Relevant professional experience actively writing regulatory documents, with a minimum of 3-5 years of experience as a lead writer on clinical study protocols, clinical study reports, and other regulatory documents.
- Education: Diploma/Master's/Bachelor's degree in science/pharmacy (Ph.D. not necessary).
- Language Skills: Fluent written and spoken English skills.
- Interpersonal Skills: Excellent, proven interpersonal skills, and the ability to work proactively as part of a team with diverse personalities.
- Flexibility: Flexibility and the ability to stay focused under tight timelines.
Remuneration will be relative to the level of experience, with all standard Trilogy benefits. We are an equal opportunities employer and welcome applications from candidates who meet the requirements.
