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.
...Overview As Microsoft continues to push the boundaries of AI, we are on the lookout for passionate individuals to work with us on the most interesting and challenging AI questions of our time. Our vision is bold and broad to build systems that have true artificial...
Title: Private Duty Registered Nurse (RN)Reports To: Director of NursingEmployment Type: Full-TimeLocation: [Clients Home] Position Summary The Private Duty Registered Nurse (RN) provides skilled nursing care to clients in their homes in accordance...
...resources and ongoing monitoring and management to clients in their home. This can include clients who are residents of Independent Living,Assisted Living or Nursing Facilities. Additionally, the Care Manager will help drive business and work with referral sources. Develops...
Under general supervision, performs a variety of cleaning and custodialduties including daily cleaning and supplying of bathrooms, offices and otherassigned areas in accordance with standard procedures. Uses cleaningdevices such as wet mops, wringers, duster, vacuum cleaner...
...This regional flatbed opportunity is built for experienced Class A drivers who want steady steel freight, strong weekly income, and guaranteed... ...driving career. Work profile Regional flatbed operation with repeat lanes Steel freight including pipe and flat...