RN Specialist at Advocate Health ensuring accurate clinical documentation and coding compliance. Collaborating with healthcare teams to improve patient record quality and completeness.
About the role
- Senior/Principal Medical Writer supporting regulatory documentation for the international pharmaceutical industry at Trilogy Writing & Consulting. Collaborating on clinical regulatory documents with client teams and managing writing projects.
Responsibilities
- Preparing 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.
- Ensuring 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.
- Providing document-specific advice to clients.
- Overseeing and coordinating other writers and QC specialists assisting on documents under your responsibility.
- Project managing the timelines and review cycles of your documents.
- Working in the client’s regulatory document management systems.
Requirements
- A minimum of a Bachelor’s degree in science/pharmacy (Ph.D. not necessary).
- Fluent written and spoken English skills.
- A minimum of 3-5 years of experience of actively writing regulatory documents; experience as a lead writer on CTD documents is required for Principal Medical Writer.
- Must have worked as the lead writer on key regulatory documents such as: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
- For Principal Medical Writer, must have experience as the lead writer with multiple-document projects with global, multinational teams, including team management, project management, review management, and budget oversight.
- Must be able to manage multiple projects simultaneously.
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- Must have in-depth working knowledge of the relevant regulatory guidance (e.g. ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance.
- For Principal Medical Writer, Experience in multiple therapeutic areas to have confidence to work in these areas without lead-in time.
- Competency in the use of document management systems and review tools.
- 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
- Annual bonus opportunity
- A generous allowance of paid time off (vacation, holiday, birthday, illness).
- Comprehensive benefit plans to include medical, dental, vision, disability, life insurance with AD&D.
- 401K retirement savings plan with company match
- Full AMWA membership and annual conference attendance paid for by Trilogy
- Continuous personal and professional development opportunities
- Free weekly yoga sessions
- Other fun and exciting events that encourage team bonding and development
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