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.
Appointment Scheduler Location Colorado Springs, CO : ~ Answers all incoming calls from patients, referring doctors, etc ~ Is responsible... ...Ability to Relocate: ~ Colorado Springs, CO 80920: Relocate before starting work (Required) Work Location: In person...
...job offers before theyre available to others Work through a trusted and reliable platform dedicated to college sitters Earn extra money by working on weekends or during school breaks Application Process Upon submission, your application will be reviewed to...
...minimum of 18 days of paid time off per year and paid holidays. For more details on our employee benefits programs, visit Life at Cigna Group . About Evernorth Health Services Evernorth Health Services, a division of The Cigna Group, creates pharmacy, care...
...programs Requirements - Valid drivers license - Clean MVR and background check - Reliable vehicle (car, cargo van, or box truck depending on route)- Smartphone for route management apps - Professional communication and reliability - Must own your Box Truck...
We are seeking a patient and encouraging tutor to assist our spirited kindergartner, Jules, in building confidence in reading. Jules is a fun, creative, and energetic 6-year-old who is experiencing some challenges in grasping the basics of reading, potentially due to early...