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.
...Saturday from 9:00 am till 6:00 pm, and rotation applies on Saturdays.Location:Head Office ZalkaSCOPE OF THE JOBThe Visual Merchandiser is responsible for implementing proper Shop's displays according to Mike Sport Visual Merchandising guidelines, the stores'...
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Seeking board eligible or board certified candidates.New graduates are encouraged to apply.ERCP or EUS experience is not required but highly valued, as these services are currently unavailable elsewhere in the community.Join a well-established practice comprising 2 board...
The Jacobs & Cushman San Diego Food Bank is currently hiring for a full-time, hourly, non-exempt and benefited, Mobile Pantry Coordinator at our Murphy Canyon location. About the San Diego Food Bank Established in 1977, the Jacobs & Cushman San Diego Food Bank is...
...looking for a proactive, highly organized, and detail-oriented Virtual Assistant (VA) to support our team. The ideal candidate will handle a... ...verbal communication skills (English). ~ Strong ability to work remotely and manage time effectively without supervision ~...