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.
...Prepares visit requests for access to job site based on appropriate clearance and need to know. Obtains and maintains appropriate security... ...information. Qualifications: ~ Must have an Active Top-Secret clearance. ~ Associates Degree or equivalent combination of...
...Position Summary In your role as Butler , it is imperative that you meticulously attend to all the personal needs of the esteemed guests that have been entrusted to your care. In preparation for their arrival, it is your responsibility to reach out to them and ensure...
...researched content for publication online and in print. Organize writing schedules to complete drafts of content or finished projects... ...demonstrated in a professional portfolio Experienced in medical writing or healthcare is advantage. An impeccable grasp of the...
...you will own the tactical day-to-day and strategic execution of search-driven programs including SEO content operations, technical... ...Oversee technical SEO, site health, and collaborate with engineering to address issues such as site speed, crawlability, structured...
Attention All Level 2 and Level 3 Certified Chrysler Techs! Get up to $20,000 Signing Bonus from Five Star Automotive Group!The Five Star Automotive Group is hiring Level 2 and 3 Chrysler Techs in our Georgia locations including Macon and Warner Robins* Must...