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.
...and an inclusive environment that celebrates the rich cultural and linguistic diversity of our students and staff. The Instructional Coach plays a key leadership role in advancing academic excellence across the academy. This position is designed for an educator who...
**Vendor fee-4%** Legal Secretary/Assistant Description Our client is a mid-size, AV-rated business litigation and insurance defense firm located in Ventura County, within walking distance from the beach. They pride themselves on a close-knit, collaborative...
...JOB? I am looking to hire students to be painters for Garcia's Painters this summer. MONDAY-THURSDAY, 35-40 hours a week painting the exterior of houses in Cincinnati. Great schedule for students who want to work hard in a shorter amount of time and then have a longer...
...We are looking for an experienced and motivated Realtor to join our team. The ideal candidate will have a strong knowledge of the real estate market, excellent customer service skills, and a passion for helping clients find their dream homes. This position requires a...
...sustainable Southeast Asian societies. CTP will generate knowledge and innovation across disciplines including climate and Earth science, ecology, materials science, artificial intelligence, humanities, social sciences and the arts, finance, health, and engineering. It will...