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.
...with owners and subcontractors to keep projects on schedule and under budget. Assist in... ...projects are constructed according to the contract documents. Execute and/or produce the... ...Office. Experience with people management. High school diploma or GED Prefer...
...explains the procedure in easy-to-understand terms performs ultrasound procedures, relieve patients of pre-testing anxiety and directly... ...related duties as assigned. Skills: Experienced Sonographer to perform high quality Adult Echo studies as per ASE & IAC...
...following languages: SPANISH, plus Arabic, Bosnian, Burmese, Cantonese, Chin, Croatian, Czech, Dari, Dutch, Farsi,French, German, Greek, Haitian Creole, Hmong, Hindi, Hungarian, Ilocano, Italian, Japanese, Khmer (Cambodian), Korean, Kurdish (Kurmanji), Lao, Mandarin,...
...Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing... ...growth opportunities. We are actively hiring Research Assistants at our Panorama City site location. This is one of our three oncology...
Lab Assistant/Phlebotomist (As Needed/PRN)PRN as neededHours will vary according to the need in the department, no set schedule.... ...College courses in biology, chemistry and math preferred.EXPERIENCE: No experience required. Previous laboratory experience preferred...