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.
...Superintendent MAJOR RESPONSIBILITIES: Safely and efficiently perform welding labor to complete construction associated with building cruise ships. Have an aggressive work ethic with a focus on production. ESSENTIAL FUNCTIONS & TASKS: Welding " to 1" steel using...
...n\t Inputting relevant contract details into databases or document management systems for record-keeping and retrieval.\n\t Reviewing scanned documents for clarity, accuracy, and completeness to ensure all information is captured correctly.\n \n Qualifications...
...Job Summary: We're seeking a Technical Project Manager with a distinguished background... ...on company and project demands. Coordinate with product owner with any shift in priorities... ...At least 2 years of experience leading remote teams distributed across the globe and...
...Job Description Job Description Salary: $24/hr Auto-Chlor System is now hiring an HR Intern in Mountain View, CA. The schedule for this position is flexible, working part-time or full-time in office. This position starts as soon as possible. Whats in it for...
...in place and establish efficient and replicable processes. They have a focus on Multi-family, Life Sciences, K-12, Municipal, Light Industrial, and Healthcare, but work in other market sectors as well. This firm is working on some of Ohio's most prominent and high profile...