Job Description:
- Support VP Oncology Regulatory Affairs and team including Sr. Directors, Director, Assoc. Directors and Managers
- Under the direction of the immediate supervisor(s), oversees the day-to-day operations of a department and follows up to ensure appropriate implementation of decisions made by supervisor.
- Acts as a resource person regarding the departments’ policies, procedures and resolves complex problems within area of responsibility.
Major Duties and Responsibilities:
- Oversees the day-to-day operations of the department.
- Establishes priorities and schedules of projects.
- Participates in the development and implementation of projects, work methods and procedures.
- Recommends procedural changes to improve unit efficiency
- Calendar Management: Manage calendars via Lotus Notes; advise others on colleagues' availability for meetings (on-and off site). Arrange meetings including Audiovisual Services, WebEx, Audio Conference and catering/luncheons (upon request). This assistant will also need to set and arrange off site meetings - for example, Regulatory arranges the rehearsal meetings in preparation for FDA meetings. This is usually off site in the Washington DC/Maryland area and would involve 10 -15 people
- Document Management: Maintain and update Oncology Reg Affairs documents. Process documents for approval. Organize and update documents.
- Invoice Processing: Process invoice transactions for Oncology Reg Affairs track invoices; obtain approval; submit for payment; monitor overdue invoices and track status of approval and payments. Contact vendors regularly to resolve any discrepancies or problems. Answer all vendor inquiries. Advise supervisor of any invoice errors or non-compliance issues. Scan copies of invoices, correspondence, and checks for filing.
- Purchase Orders: Prepare and process requisitions and purchase orders for supplies and equipment. Develop and implement purchasing and contract management instructions, policies, and procedures. Maintain records of goods ordered and received.
- Contract Approval: Coordinate with Legal, Finance, and the Oncology Reg Affairs teams to establish Master Service Agreements (MSAs) and Statements of Work (SOWs) for independent vendors and consultants. Procure federal ID numbers for each vendor; generate an Eisai vendor ID number, PO number, and SRM shopping cart. Generate bid deviation forms when necessary. Maintain binders and electronic files with contracts and bids.
- Travel Coordinator: Research travel options to finalize arrangements (i.e. car service, train/air/hotel). If conference/seminar-related, register for conference and book all logistics via conference website.
- Expense Report Submission: Process travel and entertainment expense reimbursements using ADP Concur. Reconcile purchasing cards on a monthly basis.
- Perform other administrative tasks as appropriate.
- Miscellaneous: Print, copy, and scan documents. Obtain articles and e-journals for staff using Information Express, PubMed, and other websites.
- Handle projects with Regulatory group from time to time.
Job Qualifications:
- BA/BS degree preferred.
- A minimum of 5-7 years' experience supporting multiple teams and management within Pharmaceutical industry.
- Good written & oral communication skills
- Responds to inquiries from internal and external personnel using proper judgment and initiative to ensure critical issues are handled appropriately.
- Ability to present one's self in a professional manner, respect for confidentiality and ability to manage individual relationships with diplomacy required
- Highly pro-active and productive with the ability to plan and manage tasks and long term projects with minimum supervision
- Ability to work in a fast paced environment and multitask is required
- Thorough understanding of standard PC applications (MS Word, PowerPoint, Excel & Lotus Notes)
- Organize, prioritize, and coordinate multiple work activities and meet critical deadlines
- Establish and maintain effective working relationships with those contacted in the course of the work
- Seasoned professional at executive level
- Understands and maintains confidentiality
- Manages bosses activities timely and efficiently
- Is self-starter who can anticipate needs and timing in advance, does not require direct, daily supervision
- Must be self-motivated and capable of working alone as manager(s) will be doing a fair amount of travel.
- Must be able to manage multiple tasks concurrently: Is self -starter who can anticipate needs and timing in advance, does not require direct, daily supervision
- Looking for someone who is strong, efficient, easy to get along with, good attention for details, takes initiative, problem solver, works well independently.
- Requires initiative, problem solving skills, self-direction, tact, diplomacy, and a clear, courteous, and professional manner when dealing with the internal and external customers.
All your information will be kept confidential according to EEO guidelines.
IF THIS IS THE JOB OPPORTUNITY FOR YOU GIVE ME A CALL AT 646-618-8925 ASAP! I want to know more about your preferences.
If in case you know someone who might be interested for this, feel free to pass it along. I look forward to hearing from you!
