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.
...Company: Grene Vision Group Job Title: Medical Records Specialist Department: Ophthalmology Reports To: Clinic Supervisor Location... ...according to operational standards. Retrieve patient information as directed. Maintains patient confidentiality by...
...Grain Farm Equipment Operator (6127) Location: Illinois JobNumber: 6127 Grain Farm Equipment Operator position available on a 6,000 plus acre family-owned corn and soy bean operation in northwest Illinois. Must have experience operating new equipment with GPS and...
...Location: Remote Company: Venture Smarter Salary: $3,500 $4,500/month (based on experience) Role Summary: The Transaction Coordinator will be responsible for managing and streamlining transaction processes across departments, ensuring all documents are...
...If you are experienced, reliable, and hard-working, apply today! Under general supervision, the building cleaner performs cleaning tasks and operates various types of cleaning equipment for assigned buildings. Duties Arrive on time and ready to perform shift...
Pay Rate: $19 - $21/Hour Role: Field Service Technician This is a field support role Schedule: 5 days a week including weekends and nights Overview: Position responsible for installation, maintenance and repairs on equipment...