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.
...Stelic is hiring a Project Scheduler / Planning & Controls Engineer for a major public works project in Los Angeles, CA. This hybrid role requires Primavera P6 skills to build and manage cost- and resource-loaded CPM schedules, track performance, and support executive...
Job Details The Radiology Technologist performs x-ray scans of patient's internal anatomy to aid physicians in diagnosing illnesses, diseases, or injuries. Executes radiologic services in compliance with relevant laws and regulations and provides consultation advice...
Teach English language courses to students of various levels (beginner to advanced). Develop and deliver engaging lesson plans, activities... ...their language development. Adapt teaching methods for both online and in-person settings. Participate in training programs and...
...Qualifications: Bachelors degree in Engineering (Mechanical Engineering preferred) or equivalent. Entry-level; no prior experience required. Strong proficiency with Microsoft Office (Outlook, Excel, Word, etc.). Excellent verbal and written communication...
...healthcare delivery for the nation. Purpose-Led : We help our patients live healthier, longer lives. Value-Based Care : As a Medicare Advantage health system, we focus on quality outcomesnot volume. &##127973; Practice Highlights Outpatient-Only, Adult...