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.
...Join Our Team as a Night Auditor! Position: Night Auditor About Us: At Aimbridge Hospitality we deliver exceptional guest experiences... ...Benefits After an initial waiting period those hired into full time positions are eligible for a competitive benefits package that...
...Emergency Medicine Physician Asheville, NC Pay: $265-275/hr Sign-On Bonus: $150,000 (paid over 3 years) Full-Time Opportunity Shifts: Flexible EM Board Certified Required 2025 Residents Welcome to Apply Are you an Emergency Medicine physician seeking...
...To ensure Shadow Peaks, is running and operating as safely and efficiently as possible.... ...Safety First!~Maintain fluid levels on equipment~Fuel & grease equipment~Equipment maintenance... ...times. Sitting, standing, squatting, heavy lifting and shoveling in extreme weather...
...available as wellSign-On Bonus for qualified technicians. Relocation reimbursement available for qualified technicians.Apply Today!... ..., Life insurance, Paid time off, Referral program, Relocation assistance, Retirement plan, Vision insuranceSchedule:Monday to Friday...
...Exchange. It is engaged in the construction and sale of high quality homes designed principally for the entry-level and first time move-up markets. The Company also... ...moderate Preferred Qualifications Prior CRM software experience Previous sales experience,...