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.
...Traveling Industrial Electrician (5075% Travel) Limestone / Aggregate Industry Location: West Coast Terminals (Travel required) Schedule: Full-time | Overtime available Pay: $39.00- $42.00 Travel: All travel paid (flights, hotel, and expenses) Growth...
...abilities. ~ Attention to detail. You need to know: This position requires that you stand and walk for the duration of any shift. You'll work with and around chemicals. Your work area may be wet and/or dirty and or have a strong smell. You should be...
Overview Why Choose Us? Novolex is a leading manufacturer of food, beverage, and specialty packaging that supports multiple industries including foodservice, restaurant delivery and carryout, food processing, grocery and retail, and industrial sectors. Novolex...
...Overview: Reports to: Principal, Project Manager, or Project Executive FLSA Status: Full-Time, Salaried-Exempt Normal Working Hours... ...completing project duties. Position Objective: Responsible for assisting the project team with project administration, scheduling,...
...opportunity in Olmsted Falls, OH. The welder fitter will lay out, fit, and fabricate metal components to assemble handrails using MIG Welding principles Primarily Flux core Fitting Experience 5 years structural steel/fab shop Mechanical Aptitude...