- Perform Global Compliance operations for BioCryst Pharmaceuticals with the strategic support of leadership, supporting in key initiatives as determined by Compliance strategic plans
- Support compliance operations in developing international markets, including development of processes, policies, controls, and monitoring plans
- Develop and execute monitoring plans globally
- Implement planned audits and monitoring activities as applicable, trending and reporting results to Corporate Compliance management for review by leadership committees, including:
- Design and develop Compliance monitoring and reporting applications and dashboards using Power BI and other reporting tools
- Summation of global monitoring results and preparing associated presentation of results for reporting to senior leaders, including Audit and Risk Committees
- Execute monitoring outside US as needed, either in virtual formats or live
- Execute live monitoring for advisory boards, speaker programs, and field ride-alongs as needed in coordination with global matrixed team
- Develop Data Analytics tools to help inform risk-based approaches to Compliance reviews
- Develop risk mapping and analysis tools for Global businesses, including the recommendation of risk mitigation strategies and monitoring plans
- Design new processes and controls for Global organization as identified through risk mapping
- Support Compliance Business Partners in execution of key initiatives
- Draft new policies and training programs as determined by input from Compliance leadership
- Identify process improvements and design or develop new processes where needed
- Other responsibilities as requested
- US and Global travel up to 20%
- Bachelor's degree required
- Minimum of 8 years of Corporate Compliance experience in the Pharmaceutical/Biotech industry
- Demonstrated proactivity and success implementing and operationalizing various aspects of a company's overall compliance program, including risk assessments, monitoring plans, policy development, and process design
- Demonstrated technical acumen in reporting tools, such as Microsoft Office applications, Power BI, Cognos, SQL, Qlikview, and other similar applications
- Experience with data analytics and tools
- Knowledge of compliance considerations in markets outside the US, including Europe and Asia
- Knowledge of Sunshine Act and state transparency reporting, preferably experience with Open Payments and global reporting requirements, including EFPIA and country-specific monitoring outside the US
- Demonstrated pragmatism and operational focus, seeking to assist others in finding practical, business solutions. Sound, agile decision-making and interpersonal/networking skills. Strong oral and written communication skills. Must be detail-oriented, precise and meticulous when reviewing data and records in the midst of demanding deadlines.
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Assoc. Director, Global Corporate Compliance Operations - Durham, United States - BioCryst
Description
COMPANY:
At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases.
For over three decades we've been guided by our passion for not settling for "ordinary" in our quest to develop novel medicines.
We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.
Our global headquarters is in Durham, North Carolina, our European headquarters is in Dublin, Ireland and our employees span the globe across sites in multiple countries.
We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives.
For more information, please visit our website at or follow us on LinkedIn and Instagram.JOB SUMMARY:
BioCryst is currently recruiting a team-oriented, dynamic and enthusiastic Compliance professional to be responsible for assisting in the implementation and operations of BioCryst's compliance program.
The Associate Director, Global Corporate Compliance Operations will be a key part of BioCryst's Corporate Compliance team and will collaborate with other internal and external stakeholders as necessary to implement the Corporate Compliance program globally at BioCryst.
The ideal compliance professional will possess solutions-oriented pragmatism, as well as excellent communication skills and attention to detail, with the ability to work in a cross-functional capacity to operationalize a best-in-class global compliance program.
This will be accomplished by influencing values-based decision making and driving accountability in partnership with business leaders to generate trust from customers and business partners.
This position can be 100% remote within the US.#LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:
EXPERIENCE & QUALIFICATIONS:
The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification.
They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.
The manager may assign additional responsibilities and assignments from time to time.
BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics.
BioCryst requires all U.S.
based employees to either (a) establish that they have been fully vaccinated against COVID-19; or (b) obtain an approved exemption as an accommodation.
Proof of vaccination or an approved exemption form is required after a conditional job offer has been made to the applicant and prior to the start date.
This requirement is a condition of employment at BioCryst, and it applies regardless of whether the position is located at a physical BioCryst location or is fully remote.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.
However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.
41 CFR c)
