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.
...teams performance, productivity & efficiency to the senior management. # Define team KRAs and evaluate yearly # Interface with internal support teams (HR, Facilities, IT Support, Telecoms and Transport)# Conduct internal audit review and assist in the external...
...Description Pink Stork is a leading womens wellness brand founded by Amy Suzanne Upchurch. The company offers high-quality products designed for women's unique health needs, from fertility to overall well-being. Pink Stork is dedicated to empowering women through every...
...nursing, mental health, substance use treatment, social work, dental and vision care, discharge planning, and reentry support. In addition... ...latitude for independent judgment and initiative, the Tour Coordinator (TC) assists in the oversight and management within Central...
...and through the events/broadcasts. The Production Assistant will work closely with the Production Team to produce regular live esports events as well as live broadcasts and streams of those events. PA will work in a live environment with the Producer/Director to be...
...and punctuality. Bonus Skills: Experience with CalAIM , Enhanced Care Management , or Health Plan operations. Bilingual in Spanish is a major plus! Details Schedule: Monday - Friday, 8:00 AM - 5:00 PM Location: ONSITE El Segundo, CA 902...