Associate Scientist (440735)
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POST DATE 9/13/2016
END DATE 10/11/2016
JOB DESCRIPTIONJob Description:
Overview:Monitor movement of Regulatory and Clinical documents through the Nonclinical Department. Oversee Nonclinical Team functions and guarantee quality / on time delivery of: Annual Report and Development Safety Update Report (DSUR) functional reviews; Investigator Brochure functional reviews; nonclinical sections' preparation of IND / NDA / MAA / NDS submissions (tracking for completeness and concurrence between CRO / OPDC / OPC-J); and publications procurement activities. Working with Team, generate pre-IND / pre-NDA briefing packages, as well as PIP and GDCP documents. Operate as point of contact for Nonclinical SOPs and processes. Act as a liaison between CROs and OPDC / OFRI / OPC-J / OCPI / OPF: ensure required documents and documentation are available to each CRO in order for work to proceed efficiently; provide CRO-requested information and/or ensure questions are addressed. Liaise with Program Management, Regulatory Affairs, Clinical, and Legal Departments. Key Job Responsibilities - 20% Oversee Nonclinical Team functions and guarantee quality / on time delivery of: Annual Report and Development Safety Update Report (DSUR) functional reviews; Investigator Brochure functional reviews; nonclinical sections' preparation of IND / NDA / MAA / NDS submissions (tracking for completeness and concurrence between CRO / OPDC / OPC-J); and publications procurement activities. Co-review the Nonclinical section of Annual Reports, Development Safety Update Reports (DSUR), and Investigator Brochures, providing feedback to authors (OPC-J, OPF) and reviewers, and applying suggested revisions to document in EPIC.20% - Act as a liaison between CROs and OPDC / OFRI / OPC-J / OCPI / OPF: for transmission of IND / NDA /NDS / MAA components and to ensure required documents and documentation are available to each CRO in order for work to proceed efficiently.Provide CRO-requested information and ensure questions are addressed. 40% - Liaise with Program Management, Regulatory Affairs, Clinical, and Legal Departments.Import of Regulatory and Clinical support documents, applying all applicable naming conventions.Ensure necessary databases are maintained and restructured as necessary to track documentation. Respond to requests made by Nonclinical Team to provide support for preparation of INDs, NDAs, NDSs and MAAs. Requested tasks may include: population of IND / NDA / CTD / eCTD tables; generation / update of Nonclinical Report Tables of Contents for each NDA submission; providing quality control of narratives prepared by Scientific staff and provide input to the Nonclinical Team. Maintain tracking logs of IND / NDA / NDS / MAA / CTD / eCTD components' preparation / QC (OPDC) and review / concurrence (OPC-J). Importing final nonclinical components into EPIC; structure of nonclinical sections based upon specified Submission Team criteria. Population of eCTD Document Maps and Trackers. Generate non-routine documents.Organize and catalogue nonclinical / clinical reports and publications for use by department. Generate and implement work flow procedures, to include generation of checklists and forms, and ensure compliance with Regulatory Agency and Client policies / procedures.Operate as point of contact for Nonclinical SOPs and processes.20% - Support OPDC CMC in putting together applications to the FDA for a Certificate of a Pharmaceutical Product for foreign countries and transmit to requesting countries. Knowledge:Strong working knowledge of applicable clinical, nonclinical, and US and EMA regulatory requirements,terminology, and documentation policies (eg, eCTD parameters for IND / NDA / NDS / MAA generation)Thorough understanding of Nonclinical practices and policies, as well as solid understanding of medical andclinical practices and concepts. Skills:Knowledge of principles, methods and tools for developing, scheduling, coordinating and managing projects, processes, and resources.Advanced computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).Comprehensive understanding of EPIC, IRC processes, IntraLink and SharePointOutstanding demonstrated oral and written communication skills, in particular with OPC-J, OPF and OFRI Competencies:See Individual Contributor in the competencies chart for core competencies Physical Demands and Work Environment:Travel (approximately 0%) See document Physical Demands and Work Environment for further requirements. Education and Related Experience:BS degree in Biology, Pharmacy and/or Chemistry and continuing education for appropriate regulatory requirements, with minimum 5 years experience in the pharmaceutical industryBackground in Quality Control / Quality AssuranceExperience in the position of Nonclinical Process Administrator (5+ years)Experience with all Nonclinical documents and workflows (5+ years)
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