The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

COMPLIANCE OPERATIONS MANAGER - SpringWorks Therapeutics
Location: Hybrid Stamford, CT US/ Remote
(Remote role - travel to offices or company meetings 1-2 x per quarter)


Overall Job Summary:
SpringWorks Therapeutics is a clinical-stage biopharmaceutical company with key pipeline programs in late-stage development, and is preparing for the expected launch of its lead investigational therapies. Reporting to the company's Compliance Officer, the Compliance Operations Manager will execute aspects of the operations of SpringWorks' global healthcare compliance & ethics program. The Compliance Operations Manager will work cross functionally supporting the Compliance, Privacy, and Legal Team operations including processes and systems.

Essential Duties and Responsibilities:

  • Support the Compliance function's operational objectives and various special projects with a goal of ensuring that SpringWorkers adhere to the highest legal and ethical standards in all business activities.
  • Help develop policies, procedures, and processes utilizing existing systems and new, innovative, tools and technology to further the company's mission and streamline operations
  • Create trainings, leveraging systems, and currently internal learning platforms.
  • Track and compile records of training using internal systems and centralized documentation. Provide regular training updates, status reports, and scorecards 'training metrics' for the Compliance, and Privacy organizations.
  • Help Support communication programs, and disclosure program awareness initiatives to enable all SpringWorkers to seek assistance, make suggestions, raise concerns or identify issues regarding compliance.
  • Support compliant interactions between field personnel, healthcare professionals (HCPs), and other customers through appropriate training and communication of policies, procedures and other requirements
  • Work at the direction of the Compliance & Privacy Leadership to ensure that all compliance concerns or reports of compliance violations as well as privacy matters are investigated and resolved or properly reported.
  • Assist in the management of compliance and legal operations mechanisms to meet the needs of the company as it prepares for commercialization, including without limitation, processes for debarment/exclusion screening, Sunshine Act reporting, state compliance reporting, privacy law compliance, FCPA/Anti-Bribery and fraud and abuse compliance, auditing / monitoring of healthcare participant-facing field roles, evaluating payments to HCPs against fair market value standards and oversight of the company's compliance hotline.
  • Assist with Legal Department operations as needed, including with various projects assigned by the Company's attorneys.
  • The position requires periodic travel for training, meetings, and field monitoring.

Other Duties and Responsibilities:

  • Project and system management
  • Vendor management from selection, onboarding, and regular engagement with vendors
  • Ability to work cross-functionally and effectively engage with a variety of roles at all levels of seniority

Education and Experience:

  • Education: Bachelor's degree.
  • Experience: 3+ years' experience in international / US healthcare compliance in the biopharmaceutical industry, including providing compliance advice or support, playing key roles in supporting compliance training to pharmaceutical/biotech companies including experience with learning management systems (LMS) and/or training technology.
  • Launch preparation and experience preferred.
  • License/Certificate: Healthcare Compliance Certification (Seton Hall) preferred

Skills:

  • Technical: Knowledge of healthcare laws and regulations, including the False Claims Act, Anti-Kickback Statute, Sunshine Act, FCPA/UKBA, and privacy laws and regulations.
  • Understanding and hands on experience with policies, procedures and process for spend capture, transparency, and Sunshine Act.
  • Leadership: Must possess a strong sense of ownership and responsibility, as well as a proven work ethic delivering excellent work product and exemplary customer service. Demonstrates passion for the business and this role; espouses a collaborative approach; leads by example in setting a positive tone for the compliance function. Ability to influence key stakeholders and drive decisions.
  • Communication: Must be able to present to and work effectively with a team. Excellent communicator in both the written and oral form; understands how to approach communication from a strategic perspective. Promotes ideas and new proposals persuasively; works through conflicts and difficult situations. Cultivates internal relationships and relates well to key colleagues at all levels.

Other:
Remote role - travel to offices or company meetings 1-2 x per quarter.

 Apply here
Posted 8/5/2022

DIRECTOR, CORPORATE COMPLIANCE - Regeneron
Location: Tarrytown, NY US


This Director, Corporate Compliance role is a strategic and dynamic role serving as a Compliance Navigator/Advisor to various areas of the business, with a particular focus on supporting the Commercial organization (marketing, sales, etc.). This individual will conduct day-to-day risk assessment and management to help support the vision for Compliance at Regeneron, by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison and primary point of contact for Compliance-related topics to assigned areas of the business, including headquarters- and field-based Commercial teams. This individual will integrate practical compliance best practices within business processes. In addition, this individual will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify Compliance risks and enhance monitoring opportunities. This individual will be expected to inspire proactive collaboration throughout Regeneron, enable business ownership of risk, and prioritize for impact.

Core expectations for this role include:

  • Agility: prioritizing risk and shifting between changing business areas, initiatives, and objectives;
  • Influencing and advocacy: leveraging substance and relationship-building to effectively navigate an organization and advance Compliance objectives; and
  • Driving solutions that are fit for purpose: developing practical Compliance initiatives by blending knowledge of Compliance standards, practical experience, and knowledge of potential perception/execution risk.

A typical day might include the following:

  • Integrate into business functions (headquarters- and field-based) to gain an in-depth understanding of current state processes and provide proactive Compliance guidance on the development and execution of proposed strategic and tactical initiatives;
  • Develop, enhance, and implement Compliance policies and procedures that are fit for Regeneron and reflective of applicable laws, regulations, government guidance, industry codes, and Regeneron policies;
  • Strategize business process improvements and change management implementation to support business and Compliance leadership in achieving operational gains;
  • Develop and implement strategic and practical risk assessment processes and management interventions that are aligned with prioritized risk areas particular to business operations and relevant monitoring activities;
  • Identify emerging Compliance key risk indicators to inform Compliance monitoring teams and analytics with practical insights from business activities;
  • Strategize innovative ways to transform internal education initiatives, through acting as a business partner between Regeneron Compliance training leads and business functions, to bridge current knowledge gaps with targeted training content;
  • Inform business leadership of Compliance knowledge gaps and larger organizational trends in a timely manner, while encouraging the open and proactive flow of information between colleagues and lines of business; and
  • Act as primary point of contact for business functions to provide regular advice and support to ensure appropriate Compliance controls are incorporated in decision-making processes and business projects.

This role may be for you if you:

  • Have the capabilities and ambition to embrace and model the "Regeneron Way" by:
    • Taking on big ideas through entrepreneurial spirt, drive, ownership, and perseverance;
    • Making it happen through flexibility, process & planning, and Compliance;
    • Being great together through teamwork & collaboration, being extraordinary, learning, communication, and care; and
    • Doing what's right through respect, inclusion, patient focus, safety & quality, and integrity & trust.
  • Have 5+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 3 years of experience in US Compliance and/or relevant Legal roles;
  • Have prior project management experience;
  • Demonstrate a history of successfully resolving challenging Compliance issues
  • Have the ability to effectively deliver sound and clear Compliance advice in a business setting;
  • Have demonstrated knowledge of relevant laws, regulations, and industry practices, including the US Federal Sentencing Guidelines, the Federal Anti-Kickback Statute, the False Claims Act, the Food Drug & Cosmetic Act, the Sunshine Act, the PhRMA Code (and other applicable industry codes), HIPAA, GDPR, etc.;
  • Demonstrate confidence in developing practical Compliance solutions across business processes by blending knowledge of Compliance standards, practical experience, and knowledge of potential perception/execution risk;
  • Foster a strong internal Compliance, ethics, and speak-up culture by creating an environment in which employees see the Compliance function as a strategic partner and enabler;
  • Are able to build consensus and respectfully drive decision-making regardless of issue popularity;
  • Have willingness and desire to be a strategic leader that can drive meaningful impact aligned with Compliance organization and enterprise priorities without being dictated by a precise scope of a role;
  • Have strong problem-solving and decision-making skills, with demonstrated ability to think creatively and devise solutions to challenging problems;
  • Have the ability to gain the confidence and trust of others through demonstrating and modeling judgement, integrity, and authenticity;
  • Have strong leadership and flexible interpersonal skills to navigate various team working models, to influence without authority, to build partnerships and work collaboratively with diverse teams to meet shared objectives;
  • Have the ability to independently prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data;
  • Have excellent written and verbal senior executive-level communication skills.
  • To be considered for this role you must possess a J.D. from an accredited law school, or other relevant advanced degree, and be able to demonstrate a history of successfully resolving challenging Compliance/Legal issues and ability to effectively deliver sound and clear Compliance/Legal advice in a business setting.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
 Apply here
Posted 7/30/2022

SENIOR DIRECTOR COMPLIANCE BUSINESS PARTNERS - Emergent BioSolutions
Location: Gaithersburg, MD US


I: JOB SUMMARY
Emergent is focused on continuing to evolve its strong ethics and compliance culture. The Compliance team is seeking collaborators, innovators, and problem solvers. Our team values drive us and are non-negotiable: we respect each other, have a "we" over "me" mentality, embrace diversity and inclusion, communicate transparently, and are committed to joy in our work. The Senior Director, Global Compliance is a leader on our team and is a key driver of our culture.

The Senior Director, Global Compliance is responsible for leading and supporting the continued evolution of Emergent's Global Ethics and Compliance program with a particular focus on its expanding Commercial business. This position will have broad familiarity with the laws, regulations and industry guidelines governing the activities of U.S. headquartered pharmaceutical manufacturers with operations in global markets.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Senior Director, Global Compliance Operations

  • Serve as the key strategic business partner to Emergent's Commercial business unit in the US and Internationally. Helping Commercial leaders and their teams to execute on business objectives while mitigating potential compliance-related risks inherent in the commercialization of pharmaceutical and medical counter measures products.
  • Expertise and significant experience with product launches, prescription devices, vaccines and over-the-counter medicines.
  • Experience supporting Market Access channel strategy and accounts, payor marketing, pricing and access strategy, payor and distributor contracting from a compliance perspective.
  • Experience leading ABAC and Third-Party Due Diligence exercises and advising commercial entities re: potential risk concerns and mitigations.
  • Deep knowledge of pharmaceutical industry regulations and therapeutic areas, as well as the nuances of business culture that impact business processes and compliance. Strong commercial acumen and understanding of government, market, health systems and payor dynamics.
  • Support the delivery of the E&C program across the Commercial Business Unit, building key relationships with leaders and working together with the E&C Leadership team.
  • Ensure Emergent has sufficient controls in place to manage company risks and align with regulatory obligations (monitoring plan, policy, procedure, training, risk assessment, etc.)
  • Lead discussions with senior leaders and help shape the organizational mindset around Emergent's Values to firmly embed ethical decision-making principles
  • Resolve issues and drive alignment with Commercial senior leaders concerning E&C or Commercial-driven programs (audit remediation, policy, process)
  • Collaborate with other Emergent Compliance teams (Operations and Programs) to support operations and deliver on annual goals
  • Contribute to global E&C program development (Code of Conduct, Values initiatives, Policies and Procedures, etc.)
  • Increase business acumen by obtaining therapeutic and product knowledge to support marketed and pipeline products
  • Lead the drafting of engaging and pragmatic policies and procedures in collaboration with key business stakeholders. Ensure policies and procedures reflect the businesses input, are accessible and clearly communicated.
  • Lead the development and delivery of impactful training to enterprise stakeholders at all levels of the organization in a manner that ensures understanding and applicability of requirements as it relates to Emergent's unique business operations.
  • Provide strategic input and support the execution of the enterprise compliance risk assessment process in partnership with the business, Internal Audit and Legal. Develop annual compliance work plan based on output of risk assessment.
  • Conduct monitoring and auditing of prioritized risk areas based on insights gained from compliance risk assessment. Partner with the business to address any findings.
  • Provide support for compliance investigations related to potential violations of policies, laws or regulations and oversee corrective actions with the business as needed.
  • Develop strategies in which the Ethics and Compliance team may utilize data gained through the various activities it undertakes (e.g. training, monitoring, investigations, etc.) to support the continuous evolution of program operations.
  • Serve as a resource for emerging trends in compliance, anticipate the impact on processes, and proactively engage with business stakeholders to determine how to partner together to address them.
  • Maintain a working knowledge of the various laws, regulations, and industry guidance relevant to the compliant commercialization of pharmaceutical products. This includes but is not limited to the Federal Anti-kickback Statute, False Claims Act, Food Drug and Cosmetics Act, FCPA, UK Bribery Act, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions. Knowledge on FTC regulations a plus.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:
BA/BS degree required. J.D. is strongly desired.
Experience: 10-15 years relevant compliance experience in pharma, biotech or related environment, preferably with a globally operating company.
Knowledge: Demonstrated knowledge of relevant laws governing the business activities of international pharmaceutical companies (anti-kick; data privacy; HCP spend transparency; price reporting), regulations and industry guidelines.
Skills: Savvy with digital and tech-enhanced communications and learning platforms. Comfortable developing metrics to enable the continued evolution of the compliance program.
Abilities: Demonstrated sound judgment and acts with integrity and ethics in all dealings, possesses humility, self-awareness, sense of humor, and openness to various perspectives.
Has strong organizational awareness, business acumen and ability to:

  • lead and influence without direct authority
  • enlist the support of various business functions as needed to achieve objectives
  • collaborate, encourage cooperation and teamwork across functions
  • interact effectively at all levels to influence culture and business practices
  • be creative and flexible in order to effectively communicate
  • balance a strong commitment to customer service and corporate ethics
  • effectively prioritizes and work in a fast-paced environment
  • handle multiple complex and confidential tasks

Preferred Qualifications

  • Knowledge of international healthcare compliance rules and regulations, European Codes of Practice related to the sales and marketing of pharmaceuticals;
  • knowledgeable in other compliance risk areas (e.g. trade controls, government contracts, privacy) relevant to the pharmaceutical industry in the jurisdictions where Emergent has substantial business operations (primarily U.S., Canada, UK and EU).

Travel
Up to 30% travel to meetings, to other sites and to perform certain compliance functions such as field monitoring. May include international travel.

 Apply here
Posted 7/25/2022

SENIOR DIRECTOR GLOBAL COMPLIANCE OPERATIONS - Emergent BioSolutions
Location: Gaithersburg, MD US


I: JOB SUMMARY
Emergent is focused on continuing to evolve its strong ethics and compliance culture. The Compliance team is seeking collaborators, innovators and problem solvers. Our team values drive us and are non-negotiable: we respect each other, have a "we" over "me" mentality, embrace diversity and inclusion and are committed to joy in our work. The Senior Director Global Compliance Operations (SDGCO) is a new role on our team for a forward-thinking leader with deep cross-functional, technical, and operational expertise to drive the strategic and incremental digital transformation of our function. Specifically, the SDGCO will be responsible for the design, implementation and oversight of systems, tools & data that collectively: 1) reduce risk; 2) add operational efficiency & effectiveness; 3) increase visibility over transactional interactions; and 4) strengthen capabilities to generate actionable insights thru analytics.

II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Senior Director, Global Compliance Operations

  • Designing, implementing, and overseeing Emergent's global compliance systems;
  • Supporting the design and implementation of a global risk assessment program by analyzing Emergent's compliance risk profile together with the efficacy of mitigation efforts;
  • Managing risks associated with Emergent's external interactions by establishing and maintaining processes and supporting tools to review, approve and document:
    • Contractual arrangements with risk-based external stakeholders including, but not limited to government entities, healthcare professionals and healthcare-related organizations
    • External funding requests such as grants, charitable donations, and sponsorships
    • Objective fair market value calculations;
  • Developing and launching a global compliance monitoring framework and program across the enterprise;
  • Assessing, implementing, and enhancing the collection of robust, standardized data across multiple sources to enable proactive, real-time monitoring & analytics;
  • Building capabilities to meet Emergent's regulatory reporting requirements across the globe. Examples of which include:
    • HCP/HCO Spend Disclosure Reporting
    • Compliance Program Certifications
    • Drug Price Transparency Reporting
  • Designing and implementing dynamic and static reporting including as examples, dynamic dashboards utilized by business and compliance leaders, static reports on risk assessment and monitoring activities, and reporting on Emergent's risk profile and monitoring efforts to groups such as senior management, compliance committees, and leadership teams;
  • Collaborating with relevant stakeholders across the Compliance team and other risk-management functions such as Legal, Finance, and Internal Audit, to ensure an integrated approach to compliance risk assessment, auditing and monitoring, and related processes and systems;
  • Drafting and implementing relevant internal compliance policies, procedures, tools, supporting resources and guidance as needed to execute risk assessment and monitoring strategies; and,
  • Maintaining strong, operational knowledge of the various laws, regulations, and industry guidance relevant to the compliant commercialization of pharmaceutical products. This includes but is not limited to the Federal Anti-kickback Statute, False Claims Act, Food Drug and Cosmetics Act, the OIG and DOJ guidelines, PhRMA Code, US state and local marketing compliance laws and recent government enforcement actions.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions

III: MINIMUM EDUCATION, EXPERIENCE, SKILLS

  • 10-15 years of relevant experience in a compliance operations and/or monitoring role;
  • Direct experience building, implementing, and overseeing global compliance systems, risk assessment and/or monitoring programs;
  • Demonstrated operational knowledge of relevant laws governing the business activities of international pharmaceutical companies (anti-kick; data privacy; HCP/HCO spend transparency; price reporting), regulations and industry guidelines;
  • Ability to think strategically and innovatively to find and implement solutions;
  • Technologically savvy with data modeling expertise and excellent analytical and organizational skills;
  • Strong communication skills, both written and verbal;
  • Demonstrated ability to draft and implement company policies, procedures, and effective guidance/training materials;
  • Strong organizational awareness, business acumen and ability to lead and influence without direct authority:
    • Enlisting the support of various business functions as needed to achieve objectives;
    • Collaboratively encouraging cooperation and teamwork across functions;
    • Interacting effectively at all levels to influence business practices; and
  • Demonstrates sound judgment and acts with integrity and ethics in all dealings, possesses humility, self-awareness, sense of humor, and openness to various perspectives.

 Apply here
Posted 7/22/2022

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