Offer summary

Qualifications:

Bachelor's degree from an accredited university; MBA/JD preferred., 7+ years of experience in pharmaceutical, healthcare, or relevant agency compliance program management., Strong knowledge of federal, state, and local compliance laws and regulations, including HIPAA and Anti-Kickback Statutes., Demonstrated ability to manage multiple tasks and handle confidential information with discretion..

Key responsabilities:

Develop and implement the Corporate Compliance plan to enhance existing compliance programming.

Establish and revise compliance policies and procedures to support the work plan.

Oversee training initiatives for compliance, including live sessions and LMS content.

Advise on reporting obligations and support third-party reviews of the Compliance Program.

Job description

Corporate Compliance Specialist
Remote
3 Months
Part time at about 15 hours a week - Schedule is flexible.

Description:
Reporting to the General Counsel, the Corporate Compliance Specialist will play a lead role in providing compliance advice and guidance to the global functions of regarding the Company’s Code of Conduct and Business Ethics, Corporate Compliance policies and standards, and other compliance issues and inquiries.
The Corporate Compliance Specialist together with other members, will maintain an effective Corporate Compliance Program that meets or exceeds regulatory standards for effective healthcare compliance programs. This individual will be responsible for designing, implementing, and managing compliance policies and procedures, processes, certifications, and disclosures to applicable regulators. This position will also lead the Compliance training strategy and will manage the development and implementation of training initiatives for the Corporate Compliance Program. This role advises and supports compliance investigations to ensure that such investigations are conducted in a timely, objective, and comprehensive manner and appropriate corrective action is implemented in accordance with compliance policies and procedures. This role interacts with and advises Functional Heads on compliance matters that affect the success of AskBio and the execution of its strategic business priorities.

Responsibilities
·       Manage the development and implementation of the Compliance plan designed to evaluate and enhance existing compliance programming to ensure compliance with policies, the laws and regulations and other regulatory guidance.
·       Responsible for establishing and revising existing policies and procedures to support the work plan.
·       Oversee the design and implementation of training initiatives for the plan, including live web-based sessions and LMS content. Manage the creation of content and delivery of effective training to new and existing employees.
·       Advises on and manages the reporting and disclosure obligations under the plan.
·       Support third party reviews of the Compliance Program including production of policies and procedures, transaction analysis / data sampling and requested reports.
·       Help to lead compliance with data privacy processes and governance in United States to actively help to mitigate data privacy risks, with a focus on those involving HIPAA, clinical trials and other healthcare matters and human resources.
·     Partner with Functional Heads and members of the ELT to maintain and enhance a strong culture of compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem-solving.
·       Work closely with key stakeholders including Legal, Audit, Human Resources, Finance, Communications, and Safety departments, to ensure effective implementation of compliance initiatives.
·       Champion an enterprise-wide culture of compliance and business ethics.
·       Develops, updates, and implements Corporate Compliance Program strategies, policies and procedures, oversight processes, and program controls. This role participates in the Corporate Compliance training program to deliver timely and targeted education.

Required Education and Experience
·       BS, BA (or equivalent) from accredited university.
·       Strong business ethics and integrity.
·       7+ years of pharmaceutical, healthcare, or relevant agency experience including compliance program management.
·       Deep and well-rounded knowledge of applicable federal, state, and local laws and regulations that affect the Company’s Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code of Conduct, AMA, industry guidance documents, CIA trends, Stark Law, HIPAA, regulations regarding the promotion of marketed products, EFPIA and the False Claims Act, and Anti-Kickback Statutes).
·       Experience reviewing and providing counseling regarding federal and state data privacy compliance, HIPAA and associated clauses and agreements;
·       Demonstrated ability to read, analyze, and interpret business and regulatory information and legal advice.
·       Strong project and time management skills with the ability to handle multiple tasks, set priorities, meet deadlines, and develop process efficiencies where required.
·       Able to work independently and know when to appropriately escalate an issue for resolution.
·       Demonstrated experience in handling confidential and sensitive situations and information with ability to exercise a high degree of judgment and discretion.
·       Demonstrated ability to synthesize information from diverse sources, develop options for resolution, make decisions that are rational and based on sound evidence, and determine an action plan, as needed.

Preferred Experience and Skills
·       MBA/JD/advanced degree a plus.
·       5 years or more of experience preferred with developing and monitoring a corporate compliance program and associated policies, procedures, and training; conducting and resolving internal investigations; and partnering effectively with cross-functional teams to advise on compliance matters and challenges.
·       Significant experience managing compliance within the context of a CIA and DPA highly desirable.
·       Demonstrated leadership skills, including ability to lead change efforts through effective communication and persuasion.
·       Ability to think critically, strategically and quickly analyze complex compliance circumstances and problems
·       Desire to work in a fast paced, science-based biotech setting and be a part of a highly innovative company aimed at transforming the lives of young patients with rare genetic disease.
·       Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce.
·       Exceptional written and verbal communication and interpersonal skills.
·       Ability to think critically, strategically and quickly analyze complex compliance circumstances and problems
·       Desire to work in a fast paced, science-based biotech setting and be a part of a highly innovative company aimed at transforming the lives of young patients with rare genetic disease.
·       Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce.
·       Exceptional written and verbal communication and interpersonal skills.

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Required profile