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.
We are looking to hire a Customer Service Representative to join our team. You will take responsibility for A Customer Service Representative (CSR) acts as the primary point of contact, providing support, information, and issue resolution to customers via phone, email...
...New York seeks an enthusiastic, dedicated, and mission-aligned Cook with the Food Services Department. The Food Services Team at... ...Requirements Minimum Qualifications Proof of GED or High School diploma Valid NYC DOH Food Protection Certificate A minimum...
...or Medical Surgical Floor? BJC Medical Group is looking for a Part Time Clinical Triage Nurses! Must live within 1 hour of St. Louis... ...providing you and your family with benefits and resources to help you manage your physical, emotional, social and financial well-...
...generous PTO & benefits plan, but also an impressive 401(k) retirement plan with matching and profit sharing. The Professional Land Surveyor position is a vital part a team that works hard to not only meet high expectations, but to also exceed our client's goals as well...
..., specializing in the deployment and maintenance of advanced fiber optic networks. We are committed to delivering unparalleled service... ...our network, we are looking for a skilled Fiber Optic Splicing Technician to join our dynamic team. As a Fiber Optic Splicing...