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.
...development, and industrialization of Rivian In-house Manufacturing Supply Chain, increasing internal manufacturing capabilities through smart,... ...capex strategy creation and execution. As a Senior Global Supply Manager, you will be responsible for all commercial aspects...
...Key Responsibilities Define and communicate product vision and roadmap Gather and prioritize business and customer requirements... ..., or related field ~8 years of experience as a Product Owner, Business Analyst, or similar role ~ Scrum Product Owner certification...
...team. If your goals and values align with Hondas, we want you to join our team to Bring the Future! Job Purpose The Executive Assistant position supports multiple Assistant Vice Presidents with administrative duties such as managing and maintaining daily calendars...
...and exercises in multiple regional languages. Were seeking a language expert to support our Math and Science offering in multiple Indian Languages.. ABOUT KHAN ACADEMY INDIA Khan Academy India aims to deliver a world class user experience that is locally relevant...
...way. The process diverts money already being spent on utilities and directs it into facility upgrades, covering scope development, design, bidding, construction management, commissioning, measurement and verification, and even ongoing energy management services. We have...