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.
...our team! Program Overview The Fitzs Fish Ponds Summer Internship Program is a paid, immersive, multi-track experience designed for... ...Networking & mentorship opportunities Ideal Candidates College students or recent graduates (18+) interested in business,...
...Do you have a passion for traveling and helping others plan their dream vacations? Would... ...love of travel with their desire to work remotely. Benefits : ~ All training and certification... ...can take advantage of the many Travel Agent perks such as complimentary and...
...About the Role The Boardwalk Pool- Cocktail Marketing Model Club Ops is responsible for providing prompt, friendly and efficient cocktail... ...and style should stay current and in line with current fashion standards and trends as deemed by management Scheduling flexibility...
Employment as a Contingent Worker aligns well with individuals seeking career flexibility and non-traditional work arrangements, while also being motivated to produce exceptional results in prominent roles. Magnit Direct Source is a service provided by Magnit Global that...
...Description Centerline is your one access point to limitless truck driving opportunities. Our job is to connect you with safe, rewarding... ...history will not be a contributing factor where prohibited by local law. Other compensation includes referral bonus opportunities....