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.
Sr. Flight Software Engineer Location Mountain View, CA : We're building safety-enhancing technology for aviation that will save lives. Automated aviation systems will enable a future where air transportation is safer, more convenient and fundamentally transformative to...
...investor information. Requirements Bachelors degree in Finance, Economics, Business Administration, or related field. An MBA or CFA is desirable. Minimum of 7-10 years of experience in investor relations, finance, or a related area, with a strong preference for...
Forest Properties Management, Inc. seeks an experienced Maintenance Technician to work at our Coconut Creek property. The Maintenance Technician will be responsible for carrying out corrective, preventative, cosmetic, and emergency property maintenance. A qualified ...
...ourselves and bettering the industry. 1 Hotels invites guests to live in rhythm with natureoffering spaces that restore, inspire,... ..., Front Drive, Lobby, Front Office, Fitness Center, and Housekeeping/Turndown Service. Expected Operation Presence: Wednesday ...
...artists and producers to bring awe to live audiences around the world. We are seeking a Global Logistics Manager to join our worldwide... ...Colorado, USA with the possibility of occasional remote work. Some travel is required. Job Summary: We are seeking a self-driven...