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.
Position: Remote Structural Steel Lead / Chief Estimator We are seeking an experienced Structural Steel Lead/Chief Estimator with a strong background in industrial projects , including steel erection, ductwork/boilermaker scopes, rigging, and millwright work. This is...
...Description This role of Corporate Counsel, Global Commercial Legal will support legal strategy for AbbVies Immunology medicines.... ...Kickback Statute, OIG guidance, the PhRMA Code, the Sunshine Act, Foreign Corrupt Practices Act, and competition law . Communicate...
LifeBridge Health is seeking a dedicated Case Manager Social Worker to join our Healthcare & Medical Services team. In this role, you will coordinate patient care, conduct psychosocial assessments, and develop individualized care plans to support safe transitions across...
Job Description: As a picker packer you will be responsible for finding and collecting merchandise in a warehouse and prepare the items for shipment to customers. May use a computer or scanner to check inventory and locate items. You will load items onto dollies or ...
...Drywall Repair Tech / Finisher $26$36/hr Northbrook, IL Home every night. Paid weekly. Year-round work. No production quotas. We fix drywall and plaster in people's homes on the North Shore Winnetka, Glencoe, Northbrook, Wilmette, Highland Park, Evanston. Real...