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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...customer service, and innovation. What Youll Do In this role, youll drive a truck equipped with concrete mixer to deliver ready mix concrete to various job sites in the area. Each day provides you with a different adventure as you work with our customers to...
...Description Job Title: Data and Records Clerk ... ...and member services. Work in a hybrid role 2 days... ...office, 3 days a week from home. We have immediate... ...systems. Respond to online inquiries and support tickets related to data entry, documentation, and record...
POSITION SUMMARY: The Commercial Credit Analyst will support the lenders in underwriting requests for credit extensions to new and existing... ...of loan relationships.* Must have 2+ years experience in a bank/credit union as a Credit Analyst. BENEFITS:* Competitive compensation...
Location: Oak Park, Illinois Business Unit: Rush Oak Park Hospital: Rush Oak Park Hospital Department: Security Work Type: Full Time (Total FTE between 0.9 and 1.0) Shift: 2nd Shift (2:30pm - 11pm), 3rd shift (10:30pm - 7am), weekends required Work Schedule...