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.
...you feel valued, youre empowered to do your best work. Job Summary Equinix is seeking a candidate to fulfill a U.S. Federal Government Contracts Manager role, with the candidate primarily responsible for supporting the U.S. Department of Defense and Intelligence...
...We are looking for a dedicated Estimator to join our team and specialize in providing accurate cost estimate for commercial and industrial electrical projects. Location: Russelville, KY Responsibilities: Conduct detailed analysis of project requirements...
...We are conducting a confidential search for an experienced Industrial Spray Painter to join a defense and aerospace manufacturing facility in the Huntsville, AL area. This role is responsible for surface preparation, media blasting, masking, and applying coatings...
Overview: The Post Oak Hotel is seeking a Concierge to join the only Forbes Five-Star Hotel in Texas. We hire passionate and professional colleagues who genuinely delight our guests through curated and authentic experiences. The Concierge will be responsible for...
...Job Description Own your opportunity to turn data into measurable outcomes for our customers most complex challenges. As a UiPath/RPA Solutions Developer Principal at GDIT, youll power innovation to drive mission impact and grow your expertise to power your career...