Global Audit Coordinator

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Audit Coordinator is responsible for working directly with the Global Audit Coordination, Sr. Manager to primarily monitor and manage the Quality & Compliance Audit Program.    This position works closely with Project Managers and Project Sponsors, generating documents, proactively tracking, and reporting, and providing administrative and clerical support as needed. 

Essential Functions:

• Take primary responsibility for Audit Coordination and related activities, and to effectively support, Global Audit Coordination, Senior Manager, Project Managers and Sponsors according to current ProPharma best practices.

• Effectively and proactively communicate with Project Managers and Sponsors, regarding contract documents, proposals, assignment letters, purchase orders, change orders and other contract modifications.

• Responsible for generation of documents including contract documents (NDA/CDA), proposals, change orders, affiliate agreements and assignment letters. 

• Responsible for audit setup in DOT and Workday, support, time and expense review and approval, and invoice review and approval. 

• Be an active participant in the Project Management of large audit projects. 

• Develop, generate and/or maintain audit/project reports including the audit tracking log, personnel plan and utilization reports.

• Ensure all correct documentation is in place prior to the commencement of the project in accordance with SOPs and or client training requirements. 

• Assist Global Audit Coordination, Senior Manager, , Project Managers and Sponsors with specific project reporting needs.

• Other duties as assigned.

Necessary Skills and Abilities:

• Proficient computer knowledge and computer keyboarding skills including intermediate proficiency in Microsoft Office Suite to create client documents and reports.

• Intermediate database skills to enter and retrieve information from multiple databases including ProPharma CRM and ProPharma Accounting/Project Management software. 

• Flexibility and adaptability to meet changing needs of the group.

• Strong verbal, written and interpersonal communication skills.

• Strong organization and prioritization skills; with strong attention to detail.

• Ability to work independently and within a team.

• Detail oriented to create documents and reports.

• Able to project professionalism and maintain composure in handling difficult situations and in times of stress.

• Exceptional customer service skills.

Educational Requirements:

• Required: Associate degree or equivalent work experience

Experience Requirements:

• Required: Experience in work related customer service function

• Required: Computer data entry experience

• Required: Intermediate proficiency with Microsoft Office Suite (Outlook, Word, Excel)

• Preferred: 2 years of experience in related field of expertise or 2 years of administrative experience

• Preferred: Experience within the Pharmaceutical/Medical Device Industry