About us
About Us:
BD, a leading global medical technology company that makes and sells medical devices, instrumented systems and reagents, is dedicated to improving people’s health throughout the world. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The Company’s capabilities are instrumental in combating many of the world’s most pressing diseases. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs more than 25,000 people in approximately 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, industry and the general public.

BD is an Equal Opportunity/Affirmative Action Employer

Description

 
Administrative Assistant (Clinical Development)
Job Summary:
 
Reporting directly to the VP Clinical Development Group this position will be responsible for all administrative assignments and Document Management and Change Control related functions for the Clinical Development Group supporting Quality Management, Regulatory Affairs, and Medical Affairs at BDT to ensure compliance with applicable FDA regulations, ISO standards, and company policies. 
 
 
Duties and Responsibilities:
Administrative
  • Effectively perform administrative and general office functions.
  • Coordinate travel arrangements for CDG members.
  • Prepare and submit expense reports.
  • Schedule and make arrangements for CDG member meetings.
  • Take meeting minutes as requested.
  • Purchase all supplies needed for the CDG group using SAP, E-Buy, and/or AMEX purchasing card.
  • Maintain the CDG Project Log.
  • Maintain the CDG Budget.
  • Establish and monitor all purchase orders for CDG services (e.g., calibration).
  • Develop and maintain all CDG websites (e.g., Quality Management, Regulatory Affairs).
 
Document Management
  • Manage BDT Laboratory Notebook process
    • Administer the Laboratory Notebook Audit process including issuance of reports
    • Issue Laboratory Notebooks and Databook Numbers
    • Track all notebooks from turn-in through archival at Iron Mountain
    • Retrieve notebooks from Iron Mountain upon request
    • Maintain the Lotus Notes Laboratory Notebook Database.
    • Serve as the primary contact all Laboratory Notebook questions for BDT Laboratory Notebook Holders.
    • Maintain records supporting Laboratory Notebook Compliance
    • Train new hires on the Laboratory Notebook process during QA New Hire Orientation
  • Document Management and Change Control
    • Maintain both hardcopy and electronic files in support of BDT operational functions: regulatory, QA, and clinical.  Distribute paper and electronic copies of controlled documents as needed.
    • Maintain documents in proper format per procedure.
       
    • Maintain the master list of document number assignments and process document change control requests including the formatting of final controlled documents.
    • Develop filing system and maintain all controlled documents in designated document room shared with Corporate Pre-Clinical Development.  Documents filed may include but are not limited to Design History Files, Drawings, Standard Operating Procedures, Specifications, Regulatory Submissions, Regulatory Correspondence, Clinical Trial Files, Batch Manufacturing Records, Quality Lot Release records, and Master Procedures and Forms.
    • Maintain key personnel training files in document room.
    • Create and maintain an inventory listing of all documents filed in the document room.
    • Develop document tracking databases as needed.
    • Process all Change Control Requests and update required databases.
    • Issue Document and Change Controls numbers upon request.
    • Serve as a Document System expert available to answer Document. Management questions. 
    • Update Quality Management Website as needed.
  • Maintain Calibration Inventory
    • Manage the database of 800+ instruments in the calibration program.
    • Schedule service with contract calibration vendors.
    • Serve as point of contact for calibration needs for BDT.

Qualifications
 /Education Required:
    • 2 Years of Administrative Assistant work experience and High School Diploma/GED equivalent required, 4 Year Degree in Life Sciences/related field preferred or equivalent combination of experience and education.
    • Ability to take initiative, anticipate and act in support of group needs and to function independently strongly required.
    • Person must be highly motivated, detailed oriented, and have strong problem solving skills.
    • Strong customer service skills and the ability to work with challenging individuals.
    • Must be able to prioritize time effectively and manage multiple assignments often with conflicting deadlines.
    • Specific proficiency in Word, Excel, PowerPoint, Acrobat, and Lotus Notes required.
    • Ability to develop and improve databases and spreadsheets required.
 
 Qualifications/Education
 Preferred:
    • 4 Year degree in science (Biology, Chemistry, Biochemistry, Microbiology, Chemical Engineering, etc.) or related field preferred.
    • 2+ years experience in the healthcare industry with specific experience in the pharmaceutical or medical device industry preferred.
    • Knowledge of FDA regulations including Good Manufacturing Practices and the Quality System Regulations preferred.

BD is an Equal Opportunity/Affirmative Action Employer


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