Senior Medical Writer
9 ore fa
Trilogy Writing & Consulting, a leading provider of regulatory documentation services, is seeking a highly skilled Senior/Principal Medical Writer to join our team. As a Senior/Principal Medical Writer, you will play a key role in producing high-quality regulatory documents for the international pharmaceutical industry.
Key Responsibilities:- Prepare clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Clinical Summaries in the CTD format, as the lead writer in collaboration with client authoring teams.
- Ensure timely delivery of documents, manage project budgets, and adhere to relevant SOPs and client requirements.
- Provide document-specific advice to clients and oversee the work of other writers and QC specialists.
- Project manage timelines and review cycles for documents under your responsibility.
- Relevant professional experience actively writing regulatory documents.
- Lead writer experience 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.
- Excellent written and spoken English skills, with an appreciation for well-written documents and attention to detail.
- Strong interpersonal skills and ability to work effectively in a team environment.
- Competitive remuneration based on experience.
- Standard Trilogy benefits.
- Opportunity to work with a growing company and contribute to its success.
Only candidates who meet the requirements will be considered. Please submit your CV and cover letter specifying how you comply with the experience requirements. Trilogy Writing & Consulting is an equal opportunities employer and welcomes applications from diverse candidates.
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