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.
...Here's your polished job posting, Brian: Gastroenterologist Board Certified/Board Eligible Geneva, NY | Finger Lakes Region $500,000$600,000 base salary + incentives The Opportunity Join a physician-led health system in Geneva, NY, as a Gastroenterologist...
...Job Title: Healthcare Recruiter Location: In Office/Hybrid Department: Staffing and Recruitment Job Type: Full-Time Job Summary: We are seeking a dynamic and results-driven Healthcare Recruiter to join our team. This role is crucial to the success of our...
...team environment. Commitment to diversity, equity, inclusion, and culturally responsive practices when working with employees, community partners, and individuals served. Minimum Qualifications: Bachelors or Masters degree in Accounting required. Minimum...
...Overview Brunel is hiring a Planner / Scheduler to support major capital projects for a global mining client. This role is responsible for managing project schedules, tracking progress, identifying risks, and supporting overall project delivery. You will work closely...
...Were looking for a highly organized and creative Marketing Coordinator to support our marketing initiatives and day-to-day operations. This role blends design-focused marketing work with administrative coordination , making it ideal for someone who enjoys both creativity...