Contributes to development of global regulatory documentation strategy and execution of tactics. Conceptualizes and develops medical communications for message-driven, concise reviewer-friendly clinical documents in order to support regulatory agency review. Coordinates medical writing/regulatory submission progress against global regulatory strategic communication plans. Writes or co-ordinates writing and reviews of clinical trial reports, narratives, clinical trial protocols, local working instructions, submission documents (ISS, ISE, CO, RMP), investigator brochures, annual IND updates, and other documents as needed. Reviews DPP and SAP as needed. Estimates resources needed and communicates with Director of Medical Writing. Establishes target dates for completion of assignments. Communicates with management when timelines are threatened. Establishes and enforces quality standards for documents. Adherence to Company SOPs, Best Practices, Working Instructions, as well as the accepted industry guidelines and regulations governing regulatory documents and submissions to global health authorities. Skills: The incumbent must have relevant medical/scientific knowledge, project management skills, analytical skills, knowledge of drug development and regulatory requirements, excellent written communication skills, computer skills, and ability to work as part of a team. The above are necessary to provide the depth and breadth of understanding of drug development issues. Education: College degree plus a minimum of 6-8 years experience in medical writing, preferably in the pharmaceutical industry. Evidence of the skills necessary to manage submissions. Evidence of depth of knowledge in multiple therapeutic areas desirable. Advanced degree (eg, MS, PhD) or other related qualifications (eg, Pharm D, BSN) are desirable.
...transfers goods within the Companys production area, freezers, coolers, dry storage and docking areas. ~Verifies items picked for shipping to sales orders and items received to bill of lading, purchase orders, and other documentation.Job Requirements, Education, &...
...flexible career you can grow from home. We provide complete training, flexible scheduling, and uncapped bonuses. As a Remote Virtual Assistant , youll handle administrative support, manage online communication, and assist team operationsall remotely. No prior experience...
...by the TN Department of Education Achieved top 5% growth in the state in both Math and ELA Awarded 3 Blue Ribbon Awards for Teaching Excellence: Most in the city! Profiled in The Tennessean , Newsweek, and in Doug Lemovs recent books, Teach Like A Champion...
Who we are At Balfour Beatty Communities, we are dedicated to a singular mission: delivering the quality communities people are proud to call home. We believe exceptional living experiences can only be created when We Careabout our residents, our partners, our communities...
Job DescriptionJob SummaryThis position provides oversight and leadership of clinical program execution. In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through...