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Contracts and Operations Associate, Global Medical Affairs Operations

Location San Rafael, California
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.

BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.

SUMMARY DESCRIPTION

The Medical Affairs Operations Associate will support the Global Medical Affairs Operations team by providing support with daily operations. The successful candidate must be able to follow direction and multi-task on a wide variety of projects while simultaneously maintaining a high quality of work. 

KEY RESPONSIBILITIES:

Responsibilities will cover a range of Medical Affairs operational areas as delegated and may include, but are not limited to:

Financial Management

·        Maintain departmental financial information, templates and processes for global Medical Affairs group, in collaboration with the corporate Finance group

·        Act as a resource for Medical Affairs adherence to contracting, PO set up and timely monthly accruals

·        Generate and distribute periodic reports and metrics, as requested

Contract Management

·        Serve as the Subject Matter Expert for Global Medical Affairs contract administration process from initial request for an agreement to execution and maintenance of agreements including: RFP process, bid evaluation/due diligence, contract / scope of work development, legal review, approval review and follow-up, contract status tracking; cross-functional communications and pro-active follow up; issue troubleshooting

·        Facilitate the conduct of vendor proposal review meetings

·        Deliver training to Medical Affairs personnel on contract management processes and policies

·        Provide purchasing and accounting support and guidance to Medical Affairs colleagues regarding contracting, purchase order and invoicing processes; liaise with accounting functions as required to troubleshoot and resolve issues

·        Generate and distribute monthly/periodic reports and metrics related to Global Medical Affairs programs including contract activity and related status.

New Hire Onboarding

·        Support the development and integration of Medical Affairs New Hire onboarding processes and procedures

·        Serve as liaison between hiring managers and BioMarin facilities management group to ensure that department space related needs are addressed

·        Aggregate and streamline new hire forms, templates and system set-up

·        Support hiring managers on new individual hire plans and requirements.  Connect hiring managers to appropriate resources to ensure new hire needs are accommodated

·        Deliver training to Medical Affairs personnel regarding new hire onboarding processes, training and policies

·        Assist new hires with internal systems training, issue resolution and user access

Controlled Documents & Compliance-wire

·        Facilitate and support Global Medical Affairs controlled documents management

·        Support the delivery of training to Medical Affairs personnel on controlled document management, processes and policies

·        Process Medical Affairs SOPs through the existing controlled documents systems and collaborate with the Quality function to maintain and improve this process

·        Enhance the visibility of controlled documents status for both internal and external stakeholders. Generate and distribute periodic reports and metrics

·        Assign SOP training in the GxP training system and collaborate with Global Directors, DSQ and Compliance Training to manage and update the global training curricula as needed

·        Consult regularly with Medical Affairs functional leadership to maintain listing of core Compliancewire assignments organized by function and role

·        Serve as Medical Affairs Compliancewire subject matter expert

·        Set up and issue Compliancewire assignments for new hire onboarding or on ad hoc basis

·        Generate and distribute periodic reports and metrics regarding Medical Affairs Compliancewire performance

Cross functional projects

·        SFDC administration to include data entry of Global Medical Affairs meetings/events and ongoing data maintenance of Accounts/Contacts

·        Be a resource in managing and maintaining Global Medical Affairs internal intranet page

·        Contribute to cross functional improvement projects, as appropriate



EDUCATION AND EXPERIENCE

·        BA/BS or higher in life or health sciences preferred.  Certificates or other education in regulatory compliance or contact management preferred

·        2 years of relevant experience in Finance and contract management, technology management, project management, and clinical trial management

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

About our location

San Rafael

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