Senior Associate, Compliance

Location
Sunnyvale, CA
Posted
Mar 18, 2018
Ref
2241
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
Pharmacyclics is committed to the development and commercialization of novel therapies intended to improve the quality and duration of life and to resolve serious unmet medical needs for cancer patients. Pharmacyclics is a wholly-owned subsidiary of AbbVie (NYSE:ABBV), a global, research-based biopharmaceutical company. Oncology is a key therapeutic area for AbbVie, with a portfolio consisting of three marketed products and a pipeline containing multiple promising new molecules that are being studied in more than 200 clinical trials for over 20 different types of cancer.

More than 1,200 Pharmacyclics and AbbVie research scientists, clinicians, marketing, operations and corporate professionals work in the San Francisco Bay Area. They combine their expertise in immuno-oncology, stem cells, and cell-signaling with their knowledge of bispecific antibodies, antibody-drug conjugates (ADCs), and covalent-inhibitor technologies to discover and develop novel cancer treatments. Together, we are striving to outsmart cancer.

General Position Summary/Purpose:

The Sr. Associate position works with all Business Units to ensure compliant execution of activities with United States and Puerto Rico Health Care Provider (HCP) Consultants. This position is responsible for working with the Business Units and other support functions including Legal and Regulatory Affairs to ensure that these consulting activities occur consistent with our policies and procedures, including determining eligibility of HCPs to contract with the company to provide consulting services and the appropriate rate for the services. In this position, the Associate must have a positive, supportive-client focused outlook, be able to project manage multiple activities while being able to prioritize competing demands, and be able to assess each activity adherence to company requirements.

Key Accountabilities/Core Job Responsibilities:

    Assess and manage individual and group HCP consulting activities to ensure compliance with company policies and procedures and protect the company from risk. Support the Business Units throughout the consulting activity, including providing guidance and ensuring compliance with applicable policies and procedures prior to receiving consulting services and confirming that services were provided as contracted prior to payment of the HCP to meet applicable legal requirements.
    The Associate must possess the ability to effectively work in project teams, drive results and be able to communicate (verbally and in writing) with internal business points of contact and with external HCPs. With minimal supervision, lead the review of documents and approvals for compliance and maintain proper documentation; be able to prioritize activities/requests as needed; be able to work closely with Business Units, Legal, and HCPs; and to resolve issues. Assess each HCP's qualifications and determine an appropriate rate utilizing the Fair Market Value (FMV) tool. Provide documentation status updates and ensure the final documentation is of the highest quality. Manage and analyze trends/findings reports related to the HCP Consulting process and work with the Compliance and the Business Owner and relevant stakeholders to identify and execute corrective action.
    Understand and operationalize procedures and guidelines. Drive the HCP documentation process, and work efficiently cross functionally. Participate in and is a key contributor to initiatives and advancement of greater efficiencies. Ability to independently review and process required documentation for compliance with relevant requirements. Participates in process improvement initiatives and takes initiative to develop innovative solutions to improve internal processes.
Qualifications and Requirements:

    3-4 years relevant experience in project management (marketing, promotional/non-promotional programs), business operations, pharma based compliance [OEC/Compliance] , or in-depth knowledge of the Pharma or Device industry. Deep understanding of OEC requirements, HCP reporting and all requirements associated with HCP Consulting Ability to present and explain complex information in a way that establishes rapport, persuades others and gains understanding and alignment. Exhibits strategic thinking by enhancing communications with insights and recommendations through clear, concise and professional communications to business owners and external HCPs/Customers Ability to multitask and manage multiple small to large projects in a cross-functional environment Strong customer focus and ability to not only manage but exceed customer expectations, in part by providing solutions and contingency plans to facilitate business success. Exerts authority and demonstrates strong decision making ability.

Education and Certifications:

• BA/BS or paralegal certification required; concentration in Business or advanced degree preferred.