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.
The Machine Operator is responsible for the setup, calibration, and operation of machine equipment in a Manufacturing environment (retail customization). Works from verbal or written instructions, diagrams, or models. Inspects machining operations and finished products...
...Job Description We have a distinct role in the sales of semiconductor inspection and metrology equipment to laboratories nationwide. The ideal candidate will be bilingual in Japanese and English, goal-oriented, adept at meeting forecast targets, uncovering new prospects...
...developing countries. PR/Marketing Internship: This is a part-time 12-hours per week, 12 week, unpaid remote internship. If your... ...social media and developing strategies for web-based messaging. Assisting with The Borgen Project's advocacy efforts. Experience: No...
...bring to life through our theme parks and consumer experiences. We own and operate leading entertainment and news brands, including NBC, NBC News, MSNBC, CNBC, NBC Sports, Telemundo, NBC Local Stations, Bravo, USA Network, and Peacock, our premium ad-supported streaming...
...familiar to many while presentation is unexpected, and hospitality is refreshingly sincere. The restaurant has earned and retained a Michelin Star since 2019, while Yao has recently received the distinction of this years Young Chef Award from Michelin. Notably in 2019,...