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.
Current Employees: If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position using the Career worklet,...
...technical problems, conducts work on assigned tasks & exhibits an entry type level of knowledge. Responsibilities: Assist in the... ...s Degree in relevant field required Bachelor's Degree in Engineering preferred Experience:~4 + years experience working...
...available. 6-month online course. A computer, internet and telephone are needed for this opportunity. Our Medical Billing... ...submission of medical claims. This position allows you to work remotely from your home office. Must have a high school diploma (or equivalent),...
Class A CDL Driver JobA CDL A driverPay: .45 cents a mileNo benefitsHow to apply for this Driving JobFill out a Gary's Job Board application. That same application can be used to apply to as many jobs as you'd like. Create a Driver's Account.Person to Contact...
...in 1975, Non-Profit Yakima Neighborhood Health Services serves patients in the areas of... ...: Currently licensed as a Registered Nurse in the state of Washington with a Bachelor... ...with student nurses, modeling and directing public health nurse activities. Provide...