The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

DIRECTOR, COMPLIANCE - Harmony Biosciences, LLC
Location: Plymouth Meeting, PA US


Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com.

SUMMARY:
The Exelixis Compliance Program sets policies and procedures, conducts training, and continually monitors and audits operational activities at the company in connection with a variety of laws and regulations, including but not limited to US healthcare laws governing interactions with healthcare professionals (HCP), FDA regulations, and privacy laws. The Compliance Policy and Training Manager will assist in maintaining and enhancing Exelixis' written policies, procedures and work instruction, and the various forms of training devised to educate the Exelixis workforce accordingly. More specifically, this individual will be responsible for supporting training projects and program deliverables that align to our compliance training plan and related communications. Essential business partners for this role are Commercial, Medical Affairs, Quality Assurance, Finance, Legal and HR.

DUTIES AND RESPONSIBILITIES:

  • Provide healthcare compliance advice and support to Commercial, Medical, Clinical, External Affairs and other business stakeholders in conjunction with Harmony's legal counsel.
  • Develop and implement compliance policies, SOPs, work instructions, etc., applicable to federal and state regulations, industry codes and guidance.
  • Conduct annual healthcare compliance risk assessments to prioritize and implement compliance controls.
  • Conduct live and transactional monitoring in accordance with compliance risks identified in the risk assessment.
  • Manage compliance training requirements and conduct required training classes.
  • Respond to, investigate, and remediate compliance related reports made via the ethics hotline, employees, or issues identified by Compliance.
  • Review and approve HCP fee for service arrangements.
  • Participate on review committees as applicable (e.g., External Funding Review Committees).
  • Manage Harmony's aggregate spend system and ensure the completion of federal, relevant state disclosure and transparency-driven compliance requirements.
  • Develop and implement tools which empower business stakeholders to make ethical and compliant decisions.
  • Help drive a culture of compliance throughout the organization and promote various compliance policies and procedures.
  • Maintain current understanding of laws, regulations, industry codes and guidance applicable to pharmaceutical/biotechnology business activities and Compliance, along with recent trends and changes, and help provide related internal education and training.
  • Assist the Compliance Officer with facilitating Compliance Committee meetings and act as a liaison on certain high priority cross functional projects.

SUPERVISORY RESPONSIBILITIES:

  • This position has no supervisory responsibilities.

QUALIFICATIONS:

  • Bachelors' degree, masters' degree preferred
  • 10+ years of relevant experience
  • 5+ years of experience as a healthcare compliance professional in a medical device or pharmaceutical company
  • Experience with regulators and external auditors
  • Understanding of relevant compliance laws and rules (e.g., Anti-kickback Statute, False Claims Act, etc.)
  • Strong analytical skills, with demonstrated ability to analyze compliance issues and advise accordingly
  • Demonstrated ability to manage third-party service providers
  • Excellent interpersonal skills, a commitment to professionalism, integrity and collegiality and the ability to strictly maintain confidential information.
  • Demonstrated ability to function independently with minimal guidance while simultaneously covering multi-varied project responsibilities
  • Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
  • Strong presentation skills and demonstrated ability to present to both small and large groups
  • Must think critically and creatively, and be able to determine appropriate resources for resolution of problems and have strong organizational and planning skills

PHYSICAL DEMANDS AND WORK ENVIORNMENT:

  • Travel is estimated to be 25% of the time for this position.
  • While performing the duties of this job, the noise level in the work environment is usually quiet.
  • Specific vision abilities required by this job include: Close vision.
  • Manual dexterity required to use computers, tablets, and cell phone.
  • Continuous sitting for prolonged periods.

**All prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19, or intend to be vaccinated for COVID-19, or qualify for a medical or sincerely held religious belief exemption to this vaccination requirement, prior to employment with Harmony Biosciences.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.


 Apply here
Posted 7/1/2022

POLICY & TRAINING MANAGER - Exelixis
Location: Alameda Corporate Office
Division: General & Administrative
Job Code: 1761
Department: Healthcare Compliance
GXP Employee: No
Job Function: Other
FLSA Status: Exempt
Reports To: Director, Compliance Operations
Effective Date: May 2022
Company: Exelixis, Inc. (YKK)
Experience Level: Mid-Senior Level - grades 7-11


COMPANY DESCRIPTION:
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients, and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

SUMMARY/JOB PURPOSE:
The Exelixis Compliance Program sets policies and procedures, conducts training, and continually monitors and audits operational activities at the company in connection with a variety of laws and regulations, including but not limited to US healthcare laws governing interactions with healthcare professionals (HCP), FDA regulations, and privacy laws. The Compliance Policy and Training Manager will assist in maintaining and enhancing Exelixis' written policies, procedures and work instruction, and the various forms of training devised to educate the Exelixis workforce accordingly. More specifically, this individual will be responsible for supporting training projects and program deliverables that align to our compliance training plan and related communications. Essential business partners for this role are Commercial, Medical Affairs, Quality Assurance, Finance, Legal and HR.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Evaluate policies and procedures, considering how to maximize the effectiveness of their content so they are understandable and accessible to the appropriate audience.
  • Contribute to our annual training plan development, implementation, and ongoing improvement
  • Proactively identify and address training gaps that address compliance issues/risks
  • Support on pull through internal training initiatives (e.g., Compliance Champions)
  • Support reporting, and tracking of compliance training
  • Project manage our reminder and escalation process

SUPERVISORY RESPONSIBILITIES:

  • No supervisory responsibilities

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
       Education:

  • BS/BA degree in related discipline and seven years of related experience; or,
  • MS/MA degree in related discipline and five years of related experience; or,
  • Equivalent combination of education and experience.

  • Experience

  • Experience in biotech/pharmaceuticals/healthcare - preferred but not required

  • Knowledge/Skills:

  • Ability to create engaging content that supports adult learning principles
  • Ability to work independently and be a confident collaborator
  • Excellent verbal and technical writing skills
  • Strong organizational (detail oriented), project management, and problem-solving skills
  • Ability to handle multiple tasks and prioritize appropriately
  • Dedication to quality and the highest professional standards
  • Advanced computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint), InDesign, Acrobat)

DISCLAIMER
The preceding job description has been designed to indicate 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 the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

 Apply here
Posted 6/9/2022

ETHICS & COMPLIANCE SPECIALIST - GSK CH
Location: Warren, NJ US


Are you looking for an opportunity to be a business partner to apply your data analytics skills to manage risk? If so, come and grow with GSK Consumer Healthcare!

As a Compliance Specialist you will be responsible for US Transparency Reporting (Federal Sunshine Act) and state compliance programs. You will the point of contact for the commercial organization for federal and state transparency and healthcare practitioner compliance programs.

In this role you will:

  • Lead US Transparency Reporting (Sunshine Act Reporting) and State Compliance Programs for US Consumer Healthcare
  • Ensure adequate internal controls are in place by assessing the framework, and supporting Monitoring Programs to comply with federal and state compliance programs reporting
  • Promote and encourage a “speak up” culture and coach GSK Consumer Healthcare staff to "Do the Right Thing"
  • Partner with the business to develop and oversee completion of CAPAs resulting from monitoring, audits or inspections
  • Apply data analytics to identify issues and propose solutions
  • Coordinate Grants and Donations process and committee for the US consumer business
  • Be the point of contact for the commercial organization for any Ethics and Compliance matters

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

  • Bachelor's Degree in any discipline
  • 3+ years of experience working in compliance, audit, risk management or US Transparency Reporting (Sunshine Act Reporting) and State Compliance Programs

Preferred Qualifications:
If you have the following characteristics, it would be a plus:

  • Experience in a consumer healthcare, global pharmaceutical, or other organization or consultancy firm supporting relevant clients
  • Proven track record in providing high degree of reliance, accountability, and value-added support to senior stakeholders
  • Ability to maintain confidentiality and trust around sensitive compliance issues
  • Excellent communication and interpersonal skills and the capability to flex communication style to the needs of stakeholders at every level of management as well as to content experts
  • Thorough understanding of business strategy and objectives
  • Extensive background and understanding of data analytics and reporting
  • Advanced MS Excel and Power BI skills

*LI-GSK

Why Consumer Healthcare?
Right now, we're on an incredible journey as we prepare to become the first independent, 100% focused consumer healthcare company. We’re doing this at a time when the work we do has never mattered more. Better everyday health is about improving the health and wellness of the consumers that we touch every year – over a billion and a half of them – and it goes beyond products. It's about truly helping people manage their health proactively in different ways as consumer needs evolve.

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we’re uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future. It's an opportunity to be part of something special.

Diversity, Equity and Inclusion
In Consumer Healthcare we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US).

GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve.

GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons.

Important notice to Employment businesses/ Agencies
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit GSK's Transparency Reporting For the Record site.

 Apply here
Posted 4/7/2022