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.
...Assists and encourages students and staff to properly use the facility and materials in the library. Library Assistants are paraprofessional librarians at the High School, K-8,... ...minimum of two years of progressive library experience or equivalent work experience You...
...Position: Director of Rehab Location: Kennebunk, ME, United States Pay: $40-$50 per hour Hours: 40 hours per week Schedule: Monday-Friday We are seeking a highly skilled and experienced Director of Rehab to join our team in Kennebunk, Maine. In...
...Job Title: Wellness Nurse Location: River Mills Assisted Living Chicopee Falls, Chicopee MA 01020 Hours: Full Time and Part Time and weekends as needed Job Summary: The Wellness Nurse is responsible for assisting the Resident Care Director with the overall...
...opportunities of a large enterprise. Truck Driver Tired of browsing the classifieds?... ...Requirements Hauling and dumping asphalt. Loading and unloading equipment... ...and background check. Education/Experience High school diploma or equivalent preferred...
...emotional, social and financial well-being. ~ Comprehensive medical, dental, vison, life insurance, and legal services available first day of the month after hire date ~ Disability insurance* paid for by BJC ~ Annual 4% BJC Automatic Retirement Contribution ~401(k)...