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.
...are embedded in all design and testing activities. Contribute innovative and commercially viable solutions that strengthen Halliburton's Intellectual Property portfolio. Mentor junior engineers and influence technical best practices (Principal and Advisor levels...
...and co-workers; Ability to read and interpret plans, diagrams, drawings, prints, schematics, utility maps, etc.; Ability to motivate employees and encourage a positive, upbeat workplace environment. Work Environment, Physical Demands, and Other Requirements...
...information Desired Qualifications: ~7-20+ years of qualified experience~ Mining engineering background ~ Willingness to travel to mine sites and other J-U-B offices Salary Range: $130,000 - $150,000 per year, determined by experience. Benefits:...
Job Summary: We are seeking an experienced Powder Coater with 35 years of hands-on experience to join our team. The ideal candidate will be responsible for preparing, coating, and finishing metal parts to meet high-quality standards. Attention to detail and a strong understanding...
The UPS Store - Center ManagerLocation: Alameda / Contra Costa CountyJob Type: Full-TimeJob DescriptionThe Center Manager is responsible for the daily operations of a The UPS Store retail location. This role leads the team, oversees customer service, manages financial...