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.
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Responsibilities: Contribute to all levels of the SDLC as we develop software; Help coordinate various software development efforts across the company; Collaborate with project managers and business analytics to understand and anticipate technologies needed; ...
...Are you a passionate student nurse looking to gain hands-on experience in a supportive and dynamic healthcare environment? Our Nurse Technician role offers a unique opportunity to work directly with patients under the guidance of experienced Registered Nurses and...
Department: Accounting Reports To: Chief Financial Officer (CFO) Supervises: Accounts Payable, Accounts Receivable, Payroll, Accounting Staff Position Overview The Accounting Manager is responsible for overseeing the daily accounting operations of the dealership in accordance...
...care models. We offer a dynamic and collaborative work environment with opportunities to advance and grow professionally. Clinical Sleep Liaison Full Time Advanced Sleep Management is seeking a Clinical Sleep Liaison to support our growing Dallas-Fort Worth regional...