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.
...Johns Hopkins Community Physicians (JHCP) is looking for an Internal Medicine Physician to join our Greater Dundalk practice. Johns Hopkins Community Physicians serves Maryland, Northern Virginia and Washington DC with over 40 locations. Benefits: Full-time - 3...
...extensive experience with DRG-based reimbursement for inpatient coding. This position does not apply to those pro-fee coders who have... ...credentials to demonstrate compliance with this requirement. This is a remote (work-from-home) position. Purpose: The Medical Coding...
...SpecialtyCares computerized IONM medical record.Position RequirementsBachelors, masters, or doctorate degree.Life sciences (e.g. neuroscience, biology), bio-engineering or audiology is preferred.3.0 GPA, preferred. *Please attach your bachelor's degree transcripts to...
ATS Company: Industrial Automation
...: Digital Content Designer for Web (Front End Web Developer) This role will incrementally grow our design team, reporting to the design lead and working to uplevel the creative output from Corporate Marketing. 50% - Adobe Digital Web Designer Adobe Digital...