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.
...using Zoom, email, and online tools Must be 18+ and authorized to work in the U.S. Motivated, reliable, and eager to learn What We... ...Customer Service Jobs Entry-Level Remote Jobs Work From Home Hiring Now Sales & Benefits Advisor No Experience Jobs Customer...
...Seasonal Tax Preparer (Potential Long-Term Opportunity) Company: Fiesta Auto Insurance Our Mission: At Fiesta Auto Insurance, we believe... .... All of our Fiesta Auto Insurance offices also offer income tax preparation services. Our team of professionals will ask you...
...coaches and performers far and wide! Independent Lake Camp is on a mission to create the best summer ever for their campers and we need you on board! If... .... Independent Lake Camp attracts campers and counselors from all over the USA and abroad, catering to kids aged...
...A Camp Counselor is an important member of our field team. They help create magical and impactful day camps for children ages 5-12 and teens ages 13-17. A Summer Camp Counselor works throughout our summer camp season, which runs May through August. As a Camp Counselor...