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.
...location, multi-city medi-spa brand offering a wide range of advanced aesthetic skin and body treatments, as well as cosmetic injectables. As... ...hear from you. Qualifications: Must have a valid Florida Nursing License. A minimum of 1- 2 years of experience administering...
...Addiction Psychiatry Opportunity in the Heart of Pure Michigan! Discover a Career Where Purpose Meets Paradise Are you afellowship... ...training programs for Central Michigan University College of Medicine. The addiction psychiatry opportunity is an academic faculty...
...Eligible for up to a $300 sign on bonus *** Title: Car Wash Attendant Job Overview Haffners seeks a car wash attendant. We are... ...Haffners: A Regional Leader Fueled by Family, Integrity, and Safety. At Haffner's, we're more than a company we're a family. As...
...Our skilled nursing facility is looking for a Certified Occupational Therapist Assistant COTA to fill a PRN or part-time position. You'll work in our skilled nursing facility providing exceptional, personalized care. The Certified Occupational Therapist Assistant...
...Company: Barton Malow Company Job Location: Southfield, MI Position: Project Manager (Renewable Energy) REQ ID: 11762 Position Summary Barton Malow Company is seeking Project Managers to join our team on solar and wind projects throughout the Great...