Regulatory Affairs & Clinical Operations Assistant (Contractor)

Purpose Statement

The role of Regulatory Affairs & Clinical Operations Assistant is to partner with the business to drive the appropriate administrative and logistical support in a timely and efficient way.

Responsibilities:

Regulatory Affairs:

• The administrative assistant is expected to build a solid partnership with financial controller and play a gate-keeper role in the P2P process. This includes challenging back the stakeholders on any wrong practice, counseling on the right steps to follow, setting the right expectations with vendors and providers, validating all steps are executed in compliance with company requirements and subsequently leveraging excellence in events and execution.
• Creating Shopping Carts, Purchase Orders, IOs.
• Requesting PO uplifts when needed.
• Tracking and following up on the budget with finance department.
• Submitting and receiving RA originals, documents, and files in EDA.
• Receiving all samples needed from distributers for Regulatory Affairs Department.
• Receiving invoices from vendors, reviewing and sending them for posting.
• Drafting agreements of different vendors and following up with Legal Team.
• Documenting department’s expenses of all the services.
• Sending Monthly Free Medical Samples Report to EDA for Regulatory.
• Supporting in business diner/event/travel arrangements.
• Communicating with Travel agencies to receive quotations.
• Supporting with hard and soft archiving.
• Scanning and printing essential documents and sending them to the team.
• Arranging the inspectors’ visits in terms of timing, transportation, location and expenses and coordinating with the vendor.
• Preparing variety of written materials.
• Operates and maintains files, ensuring security/confidentiality at all times.
• Adds new vendors, HCPs, and updates vendors’ information when needed through Ariba & DSP.
• When dealing with health care providers, the administrative assistant is expected to manage accurately and timely the transactions related to the stakeholders in line with ethics and compliance procedures in place, among others: Sponsorship Agreements, Contracts, Events Logistics Support, MAP support, Appropriate List of Attendees and Attendance Proofs, etc…

Clinical Operations:

• The Clinical Administrative Assistant provides administrative and clinical management support to Site M&M personnel and assist them with the in-house organization, management and execution of projects and activities undertaken by Clinical Operations Site Management & Monitoring personnel assigned to clinical studies conducted within the country.
• If applicable, creates a local trial file for the filing of Country specific original documentation and archiving system.
• Supports local Clinical Team with the handling of Essential Documents, including Contracts and Archiving. Ensures the Investigator Site Files are crated, contain the correct and complete documentation, and are shipped as appropriate to the Investigational Sites.
• In-house support for CRAs during site visits (administrative tasks, point of contact etc.)
• Acts as in-house support for CRA’s with the handling and destruction arrangements of Investigational Product as, and if, required.
• Participates in pre-audit activities. Supports CRAs to ensure audit and inspection readiness in clinical activities of responsibility.
• Supports Clinical Team in travel arrangements. Supports with organizing Team Meetings (booking meeting rooms, taking minutes and organizing catering etc.). If appropriate, assists with the filing of training records and other relevant personnel documentation for staff.
• May interface with and build professional collaborative relationships with: Local personnel including Medical Department personnel and other AbbVie personnel within Clinical Operations as well as Regulatory, Finance and Legal Functions, Human Resources, administrative staff and other relevant functional areas.
• Site Management and Monitoring personnel in other Countries and Document Management. External service providers •Study personnel (investigators, study coordinators, pharmacists, etc.)
• Peers within the organization vendors.
• Supports CRAs with the CA and EC submissions of clinical studies and related amendments, including collection of essential documents.
• Creates Shopping Carts, Purchase Orders, and ACRs and following up till receiving the proof of payments/ cheques.
• Requests PO uplifts when needed.
• Creates quarterly Breakdowns (Internal and External) for clinical studies different sites.
• Creates Annual Breakdowns for the estimated governmental payments.
• Creates Quantum invoices for clinical studies.
• Keeping the payment tracker up to date.
• Assisting with investigators site and vendor payments according to local finance processes and Quantum.
• Ensuring financial information and documents for assigned studies and sites are entered into SAP in a timely manner and is managed in compliance with company policies.
• Submits files and cheque payments to MOH, EDA, and different investigator sites .
• Supports Clinical Team in uploading approvals on Veeva Vault.
• Communicating with principal investigators of clinical trials to support in administrative work or handling issues.
• Supports CRAs with the CA and EC submissions of clinical studies and related amendments and annual renewals.
• Orders stationery items or any needed materials.

Qualifications:

• University degree, preferred pharmacy or dentistry.
• If scientific field to be fresh graduate.
• 0 - 2 years of experience in administrative support in a multinational environment with the same level of complexity.
• Very strong communication skills.
• Strong competency in using Word, Power Point, Outlook, Adobe, and other internet platforms used in managing business transactions such as SAP, or others.
• Ability to work cross functions with multiple stakeholders, with very solid prioritization skills and time management as well as confidence and assertiveness.
• Capability to work under pressure while maintain the right level of accuracy and efficiency.