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.
...day begins when you arrive at Camp (typically between 8:45 and 9:15) and ends at 4pm. In addition, all Camp Counselors are expected... ...starting pay rate of $15 per hour** for Junior Counselors (15 years-old and/or without minimally required experience) and $16 per hour for...
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...The Senior Manager of Clinical Affairs is responsible for the development and execution of clinical trials from research and development... ...60,000 plus bonus Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid...
...Neonatal Intensive Care Unit (NICU) is operated by Rady Childrens. Visit us online at: Qualifications MINIMUM ESSENTIAL EXPERIENCE Previous experience in a clinical laboratory is preferred. MINIMUM ESSENTIAL EDUCATION High School...
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