Medical Writer in Costello Medical's Medical Communications team specializing in scientific publications and communication of clinical trial data. Collaborating with clients to deliver high - quality scientific materials.
About the role
- Medical Writer preparing clinical regulatory documents in collaboration with client teams. Contributing to the production of high-quality regulatory documentation for the international pharmaceutical industry.
Responsibilities
- 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
Requirements
- Several years of professional experience actively writing regulatory documents
- Worked as the lead writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications
- 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
- 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
Benefits
- All standard Trilogy benefits
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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