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EMPLOYMENT OPPORTUNITIES

 

SR. COMPLIANCE AND ETHICS SPECIALIST - Neurocrine Biosciences
Full Time
Location: On-Site, San Diego based USA (min 40% travel)
Job Requisition ID: R4809

Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:
The Sr. Compliance and Ethics Specialist will be primarily responsible for executing key elements of Neurocrine's compliance monitoring program. The position will also support other compliance responsibilities including those related to internal investigations, training, communications, spend transparency, and special projects. The role is located at Neurocrine’s San Diego headquarters.

Your Contributions (include, but not limited to):

• Conduct field and desk monitoring to ensure compliance with applicable laws, regulations, and Neurocrine policies
• Assist in developing annual plans for monitoring activities such as Sales and Medical Affairs field rides and peer to peer educational program monitoring
• Track and report progress of Compliance monitoring, including preparation of reports/metrics to communicate findings throughout multiple levels of the organization
• Assist in the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions
• Provide sound compliance guidance consistent with applicable laws, regulations and Neurocrine policies
• Support additional compliance initiatives and projects

Requirements:

• Bachelors degree or equivalent and 4+ years of relevant experience in the biotech/pharmaceutical or medical device industry
• Compliance and Ethics Professional Certification preferred
• Understanding of healthcare compliance laws, regulations, and industry codes applicable to a pharmaceutical company with a commercial product, including federal Anti-kickback Statute, FDA promotional regulations, federal and state spend transparency laws and the PhRMA Code
• Experience in compliance solutions for data analytics, monitoring and risk management preferred
• Strong ability to use word processing and presentation software to prepare documents and training, and to use spreadsheet and statistical analysis software to store, manipulate, analyze and present data
• Ability to manage multiple projects, meet deadlines, and adjust to changes in priorities
• Strong organizational skills and attention to detail
• Strong data analytics skills
• Strong critical thinking and problem-solving skills using creativity and sound judgment
• Strong written, verbal, and listening skills
• Strong teamwork and interdisciplinary collaboration skills
• Flexible to travel (minimum 40% of time)
• In-office 3+ days per week when not traveling
  #LI-TM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $99,200.00-$143,675.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 20% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

 Apply here
Posted 7/26/2024

COMPLIANCE COUNSEL - Neurocrine Biosciences
Full Time
Location: On-Site, San Diego based USA
Job Requisition ID: R4810

Who We Are:
At Neurocrine Biosciences, we pride ourselves on having a strong, inclusive, and positive culture based on our shared purpose and values. We know what it takes to be great, and we are as passionate about our people as we are about our purpose - to relieve suffering for people with great needs, but few options.

What We Do:
Neurocrine Biosciences is a leading neuroscience-focused, biopharmaceutical company with a simple purpose: to relieve suffering for people with great needs, but few options. We are dedicated to discovering and developing life-changing treatments for patients with under-addressed neurological, neuroendocrine, and neuropsychiatric disorders. The company's diverse portfolio includes FDA-approved treatments for tardive dyskinesia, chorea associated with Huntington's disease, endometriosis* and uterine fibroids*, as well as a robust pipeline including multiple compounds in mid- to late-phase clinical development across our core therapeutic areas. For three decades, we have applied our unique insight into neuroscience and the interconnections between brain and body systems to treat complex conditions. We relentlessly pursue medicines to ease the burden of debilitating diseases and disorders, because you deserve brave science. For more information, visit neurocrine.com, and follow the company on LinkedIn, X (Formerly Twitter) and Facebook. (*in collaboration with AbbVie)

About the Role:
Responsible for compliance consultation, recommending solutions for and executing the Neurocrine Compliance and Ethics program to ensure compliance with all applicable laws and regulations.

Your Contributions (include, but not limited to):

• Conducts compliance investigations regarding allegations of potential violations of law, company policy and/or ethical standards, prepares recommendations based on results of the investigations and implements corrective actions
• Provides clear and sound compliance advice to stakeholders, management and employees at Neurocrine, consistent with applicable laws, regulations and Neurocrine policies
• Proactively conducts field and desk monitoring to ensure compliance with applicable laws, regulations and Neurocrine policies
• Provides proactive risk assessments regarding the compliance/ethics program and provides recommendations for updates/changes to the program or business operations as needed
• Acts as advisor and provides compliance input and expertise into business decisions, including development of solutions-orientated risk mitigation strategies
• Assists in addressing compliance training needs, helps to develop and deliver effective and creative training, including written materials, computer-based training and live presentations
• Performs other duties as assigned/requested

Requirements:

• Juris Doctorate Degree and 5+ years of legal and/or compliance experience
• An active license to practice law in any state
• Experience in the biotech/pharmaceutical or medical device industry
• Experience with healthcare compliance investigations
• Ability to deliver clear, concise and accurate advice, including the appropriate level of detail and anticipation of follow-up questions
• Ability to build consensus with diverse stakeholders and third parties and form strong, collaborative working relationships with clients
• Ability to anticipate business and industry issues; recommend relevant process improvements
• Excellent interpersonal skills
• Excellent communications, problem-solving, analytical thinking skills
• Ability to meet multiple deadlines across a variety of projects/programs, with a high degree of accuracy and efficiency
• Ability to understand strategic direction and incorporate it into tactical plans
• Team player focused on team and organizational success
• Integrity, honesty, and trustworthiness are core operating principles
• Flexible to travel (minimum 30% of time)
• In-office 3+ days per week when not traveling
  #LI-TM1

Neurocrine Biosciences is an EEO/AA/Disability/Vets employer.

We are committed to building a diverse, equitable, and inclusive workplace, and we recognize there are a variety of ways to meet our requirements. We are looking for the best candidate for the job and encourage you to apply even if your experience or qualifications don’t line up to exactly what we have outlined in the job description.

The annual base salary we reasonably expect to pay is $202,300.00-$292,975.00. Individual pay decisions depend on various factors, such as primary work location, complexity and responsibility of role, job duties/requirements, and relevant experience and skills. In addition, this position offers an annual bonus with a target of 30% of the earned base salary and eligibility to participate in our equity based long term incentive program. Benefits offered include a retirement savings plan (with company match), paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans.

 Apply here
Posted 7/26/2024

US INTEGRITY & COMPLIANCE OFFICER - Indivior
Full Time
Location: Richmond, VA US / Hybrid
Reports to: Deputy Compliance Officer

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:
The U.S. Integrity & Compliance Officer (USICO) reports directly to the Deputy Compliance Officer (DCO) and assists the DCO with the day-to-day leadership and administration of the Indivior Global Integrity & Compliance Program (ICP).

The USICO serves as a strategic business partner and advisor across the U.S. Business Units (Behavioral Health, Addiction Sciences, Opioid Reversal Sciences) and Global Functions residing in the U.S. (e.g., Medical Affairs, R&D, Managed Care, Marketing, Government Affairs, Corporate Communications) to ensure the effective integration and implementation of the Indivior Global Integrity & Compliance Program. In this role the USICO will be responsible for providing timely proactive and daily compliance advisory counsel and compliant solutions approaches across the U.S. business, the annual administration of the U.S. I&C Risk Assessment and Mitigation Planning (RAMP) process with integration into the Global I&C RAMP, development/delivery of training, and participation in various compliance-related processes in collaboration with the Integrity & Compliance Centers of Excellence (e.g., monitoring, global strategy and program management, operations, reports communications, investigations (for subject matter expertise input only), governance committees, and government agreement administration).

The USICO is responsible to provide sound guidance and solutions that are in full compliance with the terms of Indivior Inc. Resolution Agreement (including CIA, DOJ Compliance Measures and FTC agreement).

The USICO is appointed to serve as Chairperson of the U.S. Compliance Administration Council (and may appoint a responsible delegate) and lead the I&C's policy governance program (with responsibility for all I&C Global and U.S. policies and procedures that are I&C-owned and in collaboration with those owned by other functions).

This position will have direct line reports and will also be responsible for indirect management of a network of Compliance Champions who support function level compliance activities.

ESSENTIAL FUNCTIONS:

• Work collaboratively in the development and evolution of the ICP, under the direction of the DCO and as guided by the Indivior Global Integrity & Compliance Program multi-year maturity strategy. USICO efforts will ensure effective and appropriately paced maturity within the Indivior U.S. Business Units, and U.S.-based Global functions in coordination with the I&C Officers.
• Lead and continually evolve the design, delivery and annual review of relevant I&C policies and SOPs based on U.S. laws, regulations, guidances, Industry Codes and Government Agreement requirements.
• Provide daily support and guidance and proactive risk and solutions identification as a business advisor to assigned U.S. Business Units and U.S.-based Global Functions. The USICO will embed and facilitate ongoing evolution of the Indivior Global Integrity & Compliance Program and effective support of corporate goals, in coordination with I&C Officers.
• Establish effective working relationships and build credibility within the Company, especially at senior management and operational leadership levels. The USICO will influence with and without direct authority to support a culture of integrity and compliance, confidence with quality decision making, and "speak up" without fear of retaliation.
• Lead a team that conduct the annual U.S. RAMP within the U.S. Business Units and functions, and advise senior management and operational leadership on issues concerning integrity and compliance matters including recommending controls designed to ensure compliance, while building independent Risk IQ across Indivior Business Units and Functions. The U.S. RAMP as a component of the Global I&C RAMP program must be executed in full conformance for consistency in approach and outcomes management. As such, the responsibility for the Global RAMP program is a shared responsibility between the USICO and the other I&C Officers.
• Build and develop highly engaged, effective team that consistently succeed in delivering value-added, timely, effective and pragmatic key stakeholder solutions that are risk and priority-based.
• Collaborate across Integrity & Compliance (I&C) to share insights from role, with active participation in the development of all relevant I&C activities, policies, training to ensure fit-for-purpose based on risk mitigation and business needs.
• Co-lead the effective design and delivery of relevant ad-hoc and standardized training for the U.S. Business Units and Functions together with the Global Training Center of Excellence.
• Engage in I&C monitoring and audits as assigned. In this role, the expectation is to conduct a moderate quantity of field observations to help inform awareness of business practices, risks and opportunities.
• Provide support for reports of concern assigned as "reviews" to the various functional areas for I&C advisory input.
• Serve as lead or member of assigned compliance governance committees, demonstrating strong policy and process development, administration and regular evolution skills.
• Engage in regular external networking and personal development to ensure maintenance of knowledge level of current regulations, Industry Codes and best practices (e.g., benchmarking), and strong working knowledge and application of Indivior policies and procedures, and all Indivior, Inc. Resolution Agreement requirements and commitments.
• Carrying out other tasks and activities related to the development, execution and maintenance of the ICP as assigned.
• Measure and report on Indivior Global I&C Program maturity initiatives and related progress, in addition to report development up to Board level for sufficient oversight based on the severity of any outcomes or matters under management (one on one, management committees, Board/Committees of the Board).
• Report on CIA compliance and implementation to U.S. Government Office of Inspector General Monitors at quarterly meetings as topics warrant; presence at all meetings.

KEY CHALLENGES:

• Engaging with diverse roles and individuals across U.S. region to ensure awareness, open dialogue and accessibility, while embedding confidence in ownership of compliance
• Providing timely, proactive and pragmatic approaches to deliver solutions to business needs and challenges within the governing standards of the Indivior Global Integrity & Compliance Program
• Effective time management and organization to manage multiple priorities, while simultaneously leading and driving key strategic priorities of the Integrity & Compliance function
• Create clarity through measurement and reporting of results delivered in role
• Effectively influencing quality decision making and change management while simultaneously driving an "operating with confidence" personal accountability; ensuring ownership and accountability for the ICP effectively rests with and is managed by the workforce at all levels of the organization

MINIMUM QUALIFICATIONS:
Education: BS/BA Undergraduate degree required.

Experience: Minimum 10 years of experience in either the pharmaceutical or medical device industry including a minimum of 5 years in a senior or regional healthcare compliance role and demonstrated experience effectively leading people in a supervisory capacity.

• Detailed understanding of U.S. regulations (including Industry Codes governing healthcare compliance programs).
• Strong interpersonal skills including ability to communicate effectively with people, individually and groups; ability to communicate with technical and non-technical colleagues; ability to develop important relationships with key stakeholders and work with all levels of management and employees, as well as with external partners and vendors.
• Excellent interpersonal, communication and presentation skills, with the ability to communicate complex issues in a simple way and influence for greater outcomes.
• Ability to work closely and collaboratively within Integrity & Compliance and with other business functions and Departments as well as key external stakeholders.
• Highly impactful people leader skills and an effective driver of the change management process.
• Experience in leading, planning, effectively executing and reporting on various healthcare compliance activities (e.g., training, risk management, monitoring).
• Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups.
• Experience leading and advising within government agreement requirements and oversight is strongly preferred.
• Professional Compliance Certification required
• Law Degree or Master's Degree not required, but is preferred.

COMPETENCIES/CONDUCT:

• Flexibility in thinking and pragmatic problem-solving skills
• Excellent interpersonal, communication and presentation skills
• Strong influencing skills and ability to exercise sound, consistent business judgment
• Ability to work independently and manage a diverse and demanding workload
• Willingness to work in a dynamic, fast-paced environment
• High standards of professional integrity and independence, maintaining essential confidentiality.
• Able to effectively influence senior management and functions to drive change
• Displays a high sense of urgency and responsiveness, with quality and accuracy
• Flexible to travel (minimum 40-60% of time)
• Tenacity and robustness
• Effectively demonstrate expertise in Healthcare Compliance, leading to personal credibility and trusted advisor status among key stakeholder groups

BENEFITS: Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks' vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Leverage Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gym, fitness facility and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

GUIDING PRINCIPLES:
Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled

 Apply here
Posted 7/25/2024

SR. MANAGER, COMPLIANCE - Intra-Cellular Therapies
Department: Compliance
Location: Hybrid- Bedminster, NJ USA
FLSA Status: Exempt

About the Role:
This role will report directly to the Executive Director, Compliance with a dotted line to the Director, Transparency and Monitoring. The Sr. Manager will be responsible for developing, implementing, and maintaining various aspects of the Compliance Program including training, policy, monitoring, auditing, HCP engagements, communications, investigations, and corrective action. The Sr. Manager will also focus on partnership with home office and field stakeholders in support of Business and Compliance functions. This is a hybrid position with expectation of attendance in the office twice a week.

Job Responsibilities

• Develop, update, and implement compliance policies and procedures, including Code of Conduct.
• Training, Education and Communications: Lead the Compliance training, education, and communications program. Develop, implement, and execute all aspects of compliance training program including new hire onboarding training. Partner with Sales Training and the LMS Training Department to ensure appropriate and effective training and education across the organization. Responsible for Compliance communications including the development of content, newsletters, and maintain the Compliance website.
• Investigations: Manage internal compliance investigations and coordinate appropriate follow up actions as needed. Enforce compliance standards in partnership with key stakeholders including HR and legal. Manage the Compliance Departments Whistleblower Line and follow up.
• Monitoring and Auditing: Implement effective auditing and monitoring programs and processes to ensure effectiveness of overall compliance programs; inclusive of policies and procedures, trainings, investigations, and other compliance initiatives. Manage the Compliance Department's Incident Management Tool and all follow up.
• Risk Management: Support all risk mitigation and enhancement processes and plans. Develop risk assessment protocols for ongoing review.
• HCP Engagements: Oversee ITCI's HCP Engagement and FMV process. Partner with Finance and Legal to ensure appropriate contracting and finance controls are also met with respect to HCP engagements.
• Project Management: Identify and lead strategic projects designed to fulfill the needs of and enhance the effectiveness of the ITCI Compliance Program. Drive results-oriented process improvement.
• Other Duties: Assist the Compliance Team and CCO with the preparation of reports, summaries, and documentation for internal and/or external use and other duties as assigned.

Job Requirements

• Bachelor's degree required from an accredited college or university.
• Minimum 5-7+ years of compliance, monitoring, auditing, project management and other relevant experience within the pharmaceutical or life sciences industry.
• Working knowledge of the legal and regulatory environment within the pharmaceutical or life sciences industry.
• Ability to successful work with team and partner with internal cross-functional teams.
• Strong analytical, organizational, problem-solving, and follow up skills required.
• Ability to communicate effectively with individuals at all levels, internally and externally.
• Proactive, self-starter with a strong sense of ownership and accountability.
• Keen attention to detail.
• Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.
• Hands on experience supporting a learning management system.
• Complete all company and job-related training as assigned within the required timelines
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice
• Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability, or any other legally protected status.

 Apply here
Posted 7/19/2024

COMMERCIAL COUNSEL - SpringWorks Therapeutics
Location: Stamford, CT / Hybrid or United States (Remote)

About SpringWorks Therapeutics::
SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer.

SpringWorks has a diversified targeted oncology pipeline spanning solid tumors and hematological cancers, including clinical trials in rare tumor types and highly prevalent, genetically defined cancers. SpringWorks' strategic approach and operational excellence in clinical development have enabled it to rapidly advance its lead product candidates into late-stage trials and enter into multiple collaborations with innovators in industry and academia to unlock the full potential for its portfolio and create more solutions for patients with cancer.

SpringWorks Leadership Principles:

• Change Steward - Recognize that change is essential; set goals that align to the Company's strategy and create positive momentum for change; adapt business practices as necessary to adjust to ever changing requirements
• Excellence Driver - Drive high performance and ownership through an open dialog; recognize performance, empower teams and create accountability for results
• Growth Coach - Set clear expectations, provide frequent feedback, coaching, and encourage continuous learning; leverage individual strengths to help SpringWorkers unleash their potential and grow in their jobs and careers
• Community Builder - Establish connections with others to build strong teams that trust each other and are great at collaborating to achieve goals; create a diverse, inclusive, and psychologically safe environment

About the Role::
SpringWorks is looking for an experienced attorney to join its in-house legal function and serve as commercial counsel under the direction of the lead commercial attorney. The individual will act as the legal point person for one of SpringWorks' brand teams as well as provide support for cross-brand activities and should possess experience providing practical, sound, and high-quality legal advice on biopharmaceutical commercialization activities from pre-launch planning throughout the product life cycle.

The individual will serve as the legal reviewer for review of promotional and medical affairs materials and support commercial contracting needs, acting as a strategic business partner to the Commercial and Medical functions and collaborating with other key functions (e.g., functions supporting commercialization, Legal / Compliance colleagues, and outside law firms) to further the Legal Department's efforts to promote an environment and culture of integrity, business partnership, problem solving and risk mitigation. This individual must be able to thrive in a dynamic and fast-paced environment and work as an integral member of the team.

Key Responsibilities:

• Provide legal counsel regarding laws applicable to pharmaceutical promotion and sales (including the Food, Drug, and Cosmetic Act, FDA regulations, federal fraud and abuse laws, privacy laws, regulatory agency guidance, industry codes).
• Legal representative on the cross-functional Medical, Legal and Regulatory review committee.
• Advise on promotional materials, disease awareness materials, dissemination of scientific communications, field sales training, social media initiatives, patient services, and product labeling.
• Draft, review, negotiate contracts that support ongoing commercialization and other business operations.
• Develop and maintain expertise in applicable laws and regulations regarding commercialization of pharmaceutical products.
• Perform other duties and responsibilities as assigned.

Qualifications:

• Education: JD degree from an ABA-accredited law school with strong academic credentials.
• 7+ years in the biopharmaceutical/life sciences department of a leading law firm and/or an in-house legal department of a commercial-stage pharmaceutical corporation.
• Active member of a state bar and in good standing.
• Knowledge of healthcare laws and regulations applicable to discounts and pricing, federal and state anti-kickback statutes, state drug price transparency laws, as well as the Food, Drug & Cosmetic Act and FDA regulations and guidance.
• Skilled in drafting and negotiating a variety of agreements; ability to draft concise and effective contractual documents.
• Must possess a strong sense of ownership and responsibility, as well as a proven work ethic delivering excellent work product.
• Exhibits excellent judgement, is a self-starter, has high integrity, and is solution oriented with a collaborative approach.
• Able to work independently and under time constraints in a fast-paced and dynamic environment.
• Embody the SpringWorks Values to act with empathy and humility to drive a culture that takes ownership and accountability for their individual and teams' performance.
• Strong interpersonal communication skills to collaborate with colleagues, stakeholders, and vendors effectively and clearly in a remote hybrid work environment.
• Ability to travel occasionally including overnight stay driven by business need.
• This position must be able to work East Coast hours. #LI-Remote

Compensation:
The expected salary range for this position is $185,000 – $240,000. Actual pay will be determined based on experience, qualifications, location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

We also offer a comprehensive benefits package for our team of SpringWorkers and their families, including competitive compensation, annual cash bonuses and equity grants, 401K matching, fully covered medical, dental, and vision plans, and a full week of holiday break at year end. It's the right thing to do – and helps us be healthy, happy, and at our best for the people who need us.

Commitment to Diversity, Equity, and Inclusion:
At SpringWorks, we believe in fostering a culture of belonging. Our Employee Resource Group's (ERG) mission is to boldly live the SpringWorks values, provide resources, and deeply engage SpringWorkers and the communities we serve to foster a culture of belonging. Ensuring diversity, equity, and inclusion are integral to our organization's DNA.

EEO Statement:
SpringWorks maintains an EEO Policy providing for equitable opportunities for employment and conditions of employment to all employees and applicants regardless of actual or perceived sex (including pregnancy, childbirth, breastfeeding or related medical conditions), gender, gender identity or gender expression, sexual orientation, partnership status, marital status, familial status, pregnancy status, race, color, national origin, ancestry, caste, religion, religious creed, age, alienage or citizenship status, veteran status, military status, physical or mental disability, past or present history of mental disorder, medical condition, AIDS/HIV status, sickle cell or hemoglobin C trait, genetic predisposition, genetic information, protected medical leaves, victims of domestic violence, stalking, or sex offense, political affiliation and any and all other characteristics or categories protected by applicable federal, state or local laws. SpringWorks treats all employees and applicants fairly in the selection process (and in other personnel activities) by giving all employees and applicants the same opportunities for employment. SpringWorks' Equal Employment Opportunity Policy is intended to ensure that there are no barriers that would prevent members of a protected group from a fair and equitable opportunity to be hired, promoted, or to otherwise take advantage of employment opportunities.

This Equal Employment Opportunity Policy applies to all aspects of employment, including, without limitation, recruitment, hiring, placement, job assignment, promotion, termination, transfer, leaves of absence, compensation, discipline, and access to benefits and training. Any violation of this Policy will result in disciplinary action up to and including termination of employment.

 Apply here
Posted 7/16/2024

ASSOCIATE DIRECTOR COMPLIANCE MONITORING AND RISK MANAGEMENT - Incyte Pharmaceuticals
Location: Wilmington, DE USA
Full Time
Job Requisition ID: 4484

Background:
Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary Function):
This position reports to the Senior Director, Compliance Monitoring, Risk, and Investigations and is responsible for leading Compliance monitoring activities, developing, and tracking corrective and preventative action plans related to compliance issues, and managing risk assessments. The position will also support other Compliance responsibilities including those related to investigations; training; communications; aggregate spend; and special projects. The role is located at Incyte's global headquarters.

Essential Functions of the Job (Key Responsibilities):

• Development and communication of annual plans for monitoring activities based on risk assessments, results of current and prior monitoring activities, outcomes from investigations, and other sources including regulatory and enforcement updates and trends.
• Provide assignments to internal and external monitoring resources and conduct live, transactional, and analytical monitoring ensuring fulfillment of annual commitments.
• Develop and track corrective and preventative action plans related to confirmed compliance issues.
• Develop and maintain dashboards and metrics that accurately report on planned versus actual monitoring status, issues, and the status of corrective and preventative action plans.
• Conduct analysis to understand factors contributing to potential policy violations, develop recommendations and assist with the design of controls and standards for identified gaps in monitoring activities.
• Work closely with the Compliance Business Leads to ensure that monitoring activities continuously align to identified risk areas, adhere to the approved sample selection criteria, and are executed in a consistent manner.
• Manage the compliance monitoring system through accurate configuration and data capture, drafting business requirements, performing user acceptance testing, and assisting in the development of presentations using the system's dashboards and metrics.
• Lead the development and execution of compliance analytics that identify trends, patterns or outliers that help drive risk-based actions and decisions.
• Manage the Incyte Compliance Risk Assessment processes within the established timelines. This includes engaging Compliance, Legal and Business stakeholders, preparing reports of Risk Assessment results, and tracking and reporting on mitigation actions.
• Support the Compliance Investigation process through focused transactional monitoring and other assigned research.
• Support additional compliance initiatives and projects.

Qualifications (Minimal acceptable level of education, work experience, and competency):

• BA/BS degree required.
• 5-7 years of compliance, risk management or relevant bio/pharmaceutical industry experience.
• Knowledge of compliance laws, regulations, and industry guidelines.
• Experience independently planning and conducting complex and sensitive monitoring, including data analysis.
• Attention to detail and focus on quality work product.
• Ability to manage and prioritize projects under tight deadlines.
• Excellent written, oral communication, interpersonal, and organizational skills.
• Strong analytical, investigative, and problem-solving skills
• Solution-oriented, team focused and strong technical skills including knowledge and experience using Microsoft applications (Excel, Word, and PowerPoint)
• Ability to travel 25-35%.
• Experience in compliance solutions for data analytics, monitoring and risk management preferred.

Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.
We Respect Your Privacy Learn more at: www.incyte.com/privacy-policy.

The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate.
During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here.

You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work.

You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable).

Please contact privacy@incyte.com if you have any questions or concerns or would like to exercise your rights.

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Posted 7/2/2024

MANAGER, COMPLIANCE - Kiniksa Pharmaceuticals
Location: Lexington, MA USA

About the job
Reporting to the Associate Director, Compliance, the Manager, Compliance will serve an important role in Kiniksa's continued enhancement of its Compliance program. This position will work to assist in the implementation, maintenance, and continued improvement of Kiniksa's compliant and ethical practices and behaviors through close collaboration with internal and external business partners. The Manager, Compliance will also be primarily responsible for executing key elements of Kiniksa's auditing and monitoring program.

This role is based in our Lexington, MA office. Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.

Responsibilities (including, But Not Limited To)
Auditing & Monitoring

• Assist in developing auditing and monitoring plans
• Conduct in-person monitoring of Medical and Commercial activities to ensure compliance with applicable laws, regulations, and company policies
• Conduct desk monitoring of Medical, Clinical, Commercial, and other departmental activities to ensure compliance with applicable laws, regulations, and company policies
• Review of Medical, Commercial, and other internal documentation to ensure compliance with company SOPs and policies
• Track and report progress of Compliance auditing and monitoring, including preparation of reports/presentations/metrics to communicate findings throughout multiple levels of the organization
• Maintain knowledge of industry and enforcement trends and regulations to continuously inform and improve auditing and monitoring tools and templates
• Maintain relevant auditing/monitoring systems, tools, and dashboards

Other Responsibilities

• Work alongside employees and company leadership to maintain and further develop throughout the organization a strong culture of ethics and compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem solving
• Requires the ability to be flexible and adaptable to changes. This individual must feel comfortable in creating new processes and grow with organizational and regulatory changes
• Optimize compliance data analytics and assist in the development of data analysis tools and systems to maximize departmental efficiency
• Maintain awareness of applicable laws and regulations and keep current with changes that may affect Kiniksa's Compliance program

Qualifications

• 3-5+ years in compliance, audit, monitoring and/or other related experience in Biotech/Pharmaceuticals
• B.A./B.S. degree or equivalent required (advanced degree preferred)
• Certified Fraud Examiner (CFE), Certified Internal Auditor (CIA), Certified in Healthcare Compliance (CHC), or Project Management Professional (PMP) a plus
• Experience developing and executing audits and monitoring activities
• Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry including fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, and state marketing compliance laws
• Experience with risk assessments and business continuity planning preferred
• Experience managing complex projects with a strong attention to detail
• Strong operational and project management skills required
• Excellent organization and presentation skills. Candidate must have strong team orientation, decision making, and problem-solving skills
• Demonstrated strong written and verbal communication skills
• Proven mindset of proactive continuous improvement
• Efficient independent worker with ability to focus and drive for results
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to compliance and ethical standards
• Proficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well as previous significant experience using report building software such as Tableau, Smartsheet, Cognos Report, Query Studio, or a similar software package
• Ability to travel up to 50%

Kiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

 Apply here
Posted 5/30/2024