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.
Job Summary: Under general supervision, cleans & maintains assigned areas & performs a variety of environmental service duties in & around the medical center in order to maintain a neat, orderly, sanitary, & safe environment. Essential Responsibilities: ...
...Technology is at the forefront of this agentic revolution . Recognized by IDC as a leader in decision intelligence and cited by Gartner in its Market Guide for Decision Intelligence, were the trusted choice of global market leaders. Built on a comprehensive and...
...Employee Assistance Program ~ Disability Pay~ Life Insurance~ Growth Opportunities and more! Summary: The Quarry Manager coordinates and supervises quarry operations to ensure an adequate amount of raw material from the quarry is available to...
Pinks Window Cleaning isnt just another service company- were a movement.Since 2020, Pinks has been on a mission to bring dignity... ...simple: Be The Best Houseguest EverWere looking for a General Manager whos ready to lead, grow, and represent Pinks in the...
...JOB SUMMARY The Financial Coach is responsible for educating students and parents of the importance of managing financial resources and planning for the future. Conducts workshops, meets with students individually, and tracks student progress. Develops on-line resources...