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.
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Job details 1.Student age: 18 and above 2.Vacancies: Chemistry&Biology teacher*1 for Taizhou, Zhejiang 3.School type: a university 4.Location: Gusu Dis., Suzhou/Taizhou, Zhejiang 5.Working schedule: 18 lessons per week MAX, 2 office hrs per week, weekends off...
Class C Hiring paratransit drivers, no CDL required, paid training JobSafely operate a paratransit vehicle and transport passengers with disabilities and special needs. Communicate and assist passengers with disabilities and special needs.Adhere to Via's Standard...
No CDL Drivers wanted for Hauling Containers no CDL required We will train JobWe are looking for professional individuals to join our team. We are looking for drivers to fill our container hauling non CDL trucks. Driver responsibilities would be, ensuring containers...
...United States in accessing essential benefit programs. This opportunity is ideal for professionals seeking flexibility, meaningful work, and long-term growth. In this role, you will conduct scheduled virtual consultations with clients, helping them understand their...