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.
...pickup partsResponsibilities:* Assisting with shipping & receiving, stocking shelves, picking and delivering the correct parts to technicians and wholesale customers.Qualifications:* Valid drivers license, physically capable of assisted lifting heavy/bulky objects.
The Department of English, World Languages and Literatures at Manhattan College invites applications for an adjunct instructor for one section of French language for the fall 2024 semester.The class will be at the undergraduate level, taught in person, and will have approximately...
...students on preparing for the SAT and ACT. Math, reading, and writing tutoring of individual students from elementary school through high... ...center in individual and small group format. Evening and/or weekend availability is required RESPONSIBILITIES:* Engage and...
...collects lab samples and ensures proper labeling* Fulfills medication refill requests following approved protocols* If certified in IV therapy; starts peripheral lines, monitor and adjusts flow rates, prime IV lines, changes dressing on IV sites (if needed) and discontinues...
...office presence is required three days a week. Additionally, this position does not offer visa sponsorship.*THE POSITIONThe Email Developer will be part of a larger CRM team that drives execution of consumer relationship marketing efforts to generate revenue from the...