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.
Responsibilities Part Time Receptionist needed Saturday and Sunday Only 8am-8:30pm The Receptionist greets patients, family members, and visitors, and responds to telephone inquiries in a professional, courteous, and friendly manner at all times. Assists or...
...in Long Beach is seeking to permanent a detailed oriented Medical Admin Assistant. The Medical Admin Assistant must have at least two years... ...tasks and financial documents - Carry out general administrative and clerical tasks to support billing processes - Use analytical...
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...Deliver to Sysco Warehouses Back-hauling is a possibility Home time is every other week for 34 reset time guaranteed. Shower facilities on site. DRIVERS MUST HAVE HAZMAT WITHIN 90 DAYS Night driving Pay: $1,500 per week gross. QUALIFICATIONS Less...
DescriptionPosition at Judd Wire, Inc.Print Stripe Operator 3rd ShiftJudd Wire Inc., a Sumitomo Electric Group company, is looking for 3rd shift Print Stripe Operator in our Turners Falls, MA manufacturing facility. Individuals will be responsible to perform...