This company develops and sells clinical agents in the United States and Canada They are looking for an experienced Medical Writer with atleast 8 years of expereince to work fully remote with a small close knit team Description:This Medical Writer will be expected to deliver high quality regulatory documents in accordance with regulatory guidelines that meet ICH standards, project timelines, and specifications set forth for the projects and to act as a Medical Writing coordinator.
The “hands-on” Medical Writer is responsible for preparing clinical summary documents, including (but not limited to) Integrated Summaries of Safety and Efficacy for NDAs, MAAs, and/or NDA Supplements/Type II variations in eCTD format.
The responsibilities also include the coordination and preparation of Meeting Content Packages, and responses to regulatory authorities as well as the management and preparation of a variety of clinical documents including clinical study reports, investigator brochures for Phase I to IV clinical trials, and drug safety related documents.
Competency in the use of Documentum (or a similar document management system) is required, while some knowledge or experience with electronic publishing tools is desired.
Non-project activities also include Data Disclosure, Eudra-CT, ClinTrial.gov.Top Skills Details: CSR, protocol, Clinical writing, eCTD documents, regulatory, regulatory documentsAdditional Skills & Qualifications:
• 7-10 years of experience in regulatory writing within the pharmaceutical industry, including managing global registration dossiers.
In addition, experience in the preparation of drug safety related documents is strongly preferred.
• Experience with interactions with regulatory groups and formulating regulatory strategies desirable.
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Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.