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.
...mission is to increase yield in protein production to help feed the growing world population... ...is a prominent provider of tools for managing performance in Live Animal Protein Production... ...seeking a driven and detail-oriented Junior Product Owner to join our dynamic...
...that promotes expanding your business? re:fab is a full-service painting and renovation company Apply today and Check us out at... ...reliable & insured truck or van Working cell phone This is a subcontractor position re:fab provides equal employment (EEO) to all...
Description Futures start here. Where first steps, new friendships, and confident learners are born. At KinderCare Learning Companies, the first and only early childhood education provider recognized with the Gallup Exceptional Workplace Award , we offer a variety...
House Cleaners:~Driver License~Experience as House Cleaner~Good attitudes~Teamwork oriented~Primary Language: Spanish~Secondary Language: English~Preferably: from Suffolk County (near Brentwood, NY)~Available to work Saturdays~References are required....
No experience needed - con o sin experiencia tiempo medio y tiempo completo Estamos solicitando un ayudante de cosina. Somos un restaurante de comida rapida mexicana. Responsabilidades: Servir platillos Limpieza Preparacion de alimentos Lavar...