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.
...Job Responsibilities: Design, implement, and optimize audio signal processing algorithms in Python and C++. Develop systems and... ...Bachelors degree in Computer Science, Electrical Engineering, or Audio Engineering required Ability to work with data base...
...Analyst will support the G&A and R&D organizations as a strategic finance partner, providing financial insight, forecasting, and... ...support to drive informed decision-making. This role sits within the Corporate FP&A team in the Office of the CFO and works closely with cross...
Position: Outbound Sales Representative Real Estate (UAE Properties) Location: Remote (must be based in the United States) Job Summary Our client is looking for an English fluent, confident outbound sales professional to call prospective buyers in the United States...
...This is a remote position. The Online Chat Representative is responsible for providing customer support through online chat platforms. This role involves responding to customer inquiries, providing accurate information, resolving issues, and ensuring a positive and...
...leader in the aesthetic industry, dedicated to elevating the social media and Google presence of plastic surgeons through innovative branding... ...over $200 billion by 2030. Job Role: Our Social Media Interns are crucial to our mission. They manage comprehensive social...