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.
...menus. Produce and follow-up on all pastry production. Manage inventory and par-levels; communicate purchasing needs to Bakery Manager. Execute recipes, menus, and specifications in accordance with company standards. Consistently deliver quality food...
...great team! DMC Primary Care , a physician-owned, independent practice, is seeking a part-time or full-time experienced Family Nurse Practitioner to join our growing team of primary care providers. This position is located in Concord, NH. Responsibilities: The...
Digital Pulp is looking for a passionate and talented Drupal Back-End Developer to create exemplary and interactive brand experiences for our clients.We are seeking someone that has had a significant development role on a large scale Drupal 8 project from conception to...
...Description The Center on Aging and Health is seeking a dedicated Certified Nursing Assistant (CNA) to join our Nursing department for the night shift in Erwin. This is a full-time, on-site position that offers a rewarding opportunity to provide compassionate care to...
...Portnovo Logistics LLC is an Amazon Delivery Service Partner (DSP) looking... ...to join our new Personal Vehicle Relay Delivery Program to deliver... ...allows you to use your own qualifying SUV or larger vehicle... ...opportunities are available. Non-CDL drivers welcome! Compensation &...