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.
...solutions. Over the past couple years we set out to develop our own GPS rover solution. With the successful launch and continued... ...rover we are looking to add an experienced Kotlin/Java based Android App Developer. This contracted position will have a base salary...
...Hiring immediately for Class A Driver! CDL- A Driver / Truck Driver Responsibilities: Dry Van Must pull trailers with manual pallet jack Average $900-$1350 weekly Mostly Drop & Hook/Shuttle Run in IL, WI, and MN Unload and D&H pay Start between...
...Job Title: RN Location: WILLIAMSON STREET Department Name: Infusion Therapy Req #: 0000219719 Status: Hourly Shift: Day Pay Range: $46.90 - $63.09 per hour Pay Transparency: The above reflects the anticipated hourly wage range for this position...
...award-winning leader in the heavy civil construction industry. Since 1972, the family... ...Position Summary: The Construction Laborer plays a vital role in Heavy/Civil Construction... ...2-5 years of Heavy/Civil Construction experience. Must be able to follow verbal instructions...
...Physician Assistant Emergency Department Non Exempt, DVH United Health Services is seeking a Physician Assistant Emergency Department Non... ...Emergency Department department at DVH in Walton, NY. This is a Per Diem position. Shift: All Shifts Hours per week: 0...