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.
...stated otherwise. What You'll Brew: ~ Sell our entire Boston Beer Company (BBC) product portfolio ~100% focus on selling... ...accounts ~ Conducting waitstaff / bartender educations, beer tastings and evening promotions ~ Working conditions vary greatly day...
...Why USAA? At USAA, our mission is to empower our members to achieve financial security through highly competitive products, exceptional service and trusted advice. We seek to be the #1 choice for the military community and their families. Embrace a fulfilling career...
...and leadership. Join us to work hard, do good, and make a lasting difference!Job DescriptionThe English as a Second Language (ESL) Teacher will help provide and guide instruction for K12 ESL students across several campuses at North Star Academy. The ESL teacher...
...those who successfully filed for CONSULTANT (EARLY CHILDHOOD EDUCATION) Exam No. 5059 within the filing... ...child care environment and actively works to improve and expand access to high... ...serving New Yorkers. Work From Home Policy: Depending on your position,...
...developing, serving, and supporting retail and convenience centers and gas station properties, and a leading distributor of high-quality branded... ...ethics. - Other duties as assigned. Core Competencies: Time Management - Value time and use your time effectively and...