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.
...Description At Hyatt, we believe our guests select Hyatt because of our caring and attentive associates who are focused on providing efficient service and meaningful experiences. The Houseperson - Events is responsible for setting up and breaking down all meeting...
...) Experincia com Snowflake Experincia com servios AWS Conhecimento em modelagem de dados e boas prticas de arquitetura (Data Lake, Data Warehouse) Experincia com ferramentas de orquestrao de dados (como Airflow, Step Functions ou similares) Diferencial...
...on peoples faces? Then you might be an excellent fit for the hotel front desk agent position on our guest services team! Youll welcome... ...the hospitality industry as a hotel front desk agent, hotel receptionist, or guest service specialist preferred Comfortable taking...
...Pay: $17 - $31 per hour Start Date: In 1-2 Weeks Location: Chapel Hill, NC Job Description Newborn babysitter needed near... ...and time management skills are required. Ability to work flexible hours and handle a fast-paced environment. High school diploma or...
...A leading real estate services firm in Washington, DC is seeking a General Manager responsible for managing properties and ensuring client satisfaction. The ideal candidate will have over 7 years of experience in commercial real estate and a strong track record in financial...