Senior Director - Compliance
To see similar active jobs please follow this link: Remote Legal jobs
Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The Senior Director, Compliance at Nuvation Bio will be responsible for executing on the day-to-day function of the compliance program relating to the development and commercialization of Nuvation Bio’s drug products, including policy development, training, auditing and monitoring, investigations, aggregate spend/transparency reporting, and state marketing requirements.
This person will also be a collaborator with the Commercial, Medical Affairs, R&D, and Patient Advocacy teams and will work closely with cross-functional stakeholders across the Nuvation Bio organization. This role reports to the VP, Legal and Head of Compliance and will be based in one of Nuvation’s corporate offices (San Francisco, New York City or Boston) or remote in the U.S. (although may be required, as needed, to perform duties at Nuvation’s corporate offices).
You will be responsible for…
Assist in the development and oversight of Nuvation Bio’s global healthcare compliance program
Advise on healthcare compliance matters, including company policies and practices regarding (i) Nuvation Bio’s products, (ii) interactions with healthcare professionals, patients, managed care entities, academic institutions, government entities, (ii) patient advocacy, access and assistance programs, and (iii) transparency
Develop policies and training materials to support compliance with laws relating to commercialization of pharmaceutical products
Advise on risk management with respect to commercialization of pharmaceutical products, including identification, prioritization, and mitigation of risk
Assist with other projects from time-to-time, including compliance matters outside of healthcare, privacy, internal investigations, audits, and/or regulatory matters
What Knowledge & Experience you'll bring to us...
Minimum of 10 years work experience in compliance or law in a pharmaceutical or biotechnology company compliance or legal department and/or well-recognized law firm
Significant experience interacting with commercial, medical affairs, and research & development departments, and handling complex legal and compliance issues
Specific expertise in the U.S. Food and Drug Administration advertising and promotion regulations, FDCA, False Claims Act, Anti-Kickback Statute, OIG Guidance, foreign anti-bribery laws, privacy laws, and US and ex-US transparency reporting laws and industry codes (e.g., Sunshine Act, US PhRMA Code)
Experience with at least one pharmaceutical product launch preferred
Strong organizational, interpersonal and people-management skills
Strong critical thinking skills and the ability to grasp important business, legal and compliance issues and to appropriately balance risk mitigation with corporate objectives and priorities.
Outstanding interpersonal and leadership skills, with the ability to build strong relationships across functions and to communicate effectively with senior business leaders, as well as other professionals and colleagues at all levels of an organization.
Ability to work under pressure and meet deadlines
Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with internal clients
Dedication to quality and the highest professional and ethical standards
Behavioral skills to be successful...
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence, curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
Competitive Base Salary, Bonus, and Equity Plans
Unlimited Vacation and 10 Sick Days Annually
Excellent Medical, Dental, and Vision Coverage
401K with Company Matching
and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.
About the job
Senior Director - Compliance
To see similar active jobs please follow this link: Remote Legal jobs
Who we are…
Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.
What you’ll be doing
The Senior Director, Compliance at Nuvation Bio will be responsible for executing on the day-to-day function of the compliance program relating to the development and commercialization of Nuvation Bio’s drug products, including policy development, training, auditing and monitoring, investigations, aggregate spend/transparency reporting, and state marketing requirements.
This person will also be a collaborator with the Commercial, Medical Affairs, R&D, and Patient Advocacy teams and will work closely with cross-functional stakeholders across the Nuvation Bio organization. This role reports to the VP, Legal and Head of Compliance and will be based in one of Nuvation’s corporate offices (San Francisco, New York City or Boston) or remote in the U.S. (although may be required, as needed, to perform duties at Nuvation’s corporate offices).
You will be responsible for…
Assist in the development and oversight of Nuvation Bio’s global healthcare compliance program
Advise on healthcare compliance matters, including company policies and practices regarding (i) Nuvation Bio’s products, (ii) interactions with healthcare professionals, patients, managed care entities, academic institutions, government entities, (ii) patient advocacy, access and assistance programs, and (iii) transparency
Develop policies and training materials to support compliance with laws relating to commercialization of pharmaceutical products
Advise on risk management with respect to commercialization of pharmaceutical products, including identification, prioritization, and mitigation of risk
Assist with other projects from time-to-time, including compliance matters outside of healthcare, privacy, internal investigations, audits, and/or regulatory matters
What Knowledge & Experience you'll bring to us...
Minimum of 10 years work experience in compliance or law in a pharmaceutical or biotechnology company compliance or legal department and/or well-recognized law firm
Significant experience interacting with commercial, medical affairs, and research & development departments, and handling complex legal and compliance issues
Specific expertise in the U.S. Food and Drug Administration advertising and promotion regulations, FDCA, False Claims Act, Anti-Kickback Statute, OIG Guidance, foreign anti-bribery laws, privacy laws, and US and ex-US transparency reporting laws and industry codes (e.g., Sunshine Act, US PhRMA Code)
Experience with at least one pharmaceutical product launch preferred
Strong organizational, interpersonal and people-management skills
Strong critical thinking skills and the ability to grasp important business, legal and compliance issues and to appropriately balance risk mitigation with corporate objectives and priorities.
Outstanding interpersonal and leadership skills, with the ability to build strong relationships across functions and to communicate effectively with senior business leaders, as well as other professionals and colleagues at all levels of an organization.
Ability to work under pressure and meet deadlines
Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with internal clients
Dedication to quality and the highest professional and ethical standards
Behavioral skills to be successful...
Problem-Solver - As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
Credible - Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Emotional intelligence, curiosity, and a knack to figure out a way to build something better
Communication - Effectively listens, conveys, and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.
Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.
Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system, process, technology, or idea in the organization. You could reassess priorities, alter goals and take risks.
What we have for you!
Competitive Base Salary, Bonus, and Equity Plans
Unlimited Vacation and 10 Sick Days Annually
Excellent Medical, Dental, and Vision Coverage
401K with Company Matching
and much more!
The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge, skills, experience, and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package, in addition to a full range of medical, financial, and/or other benefits, depending on the level and position offered.
Disclaimer
Nuvation Bio, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by the law.
This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio, Inc., will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.