The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

CLINICAL DEVELOPMENT COMPLIANCE MANAGER - AbbVie
Location: Lake County, IL USA


About AbbVie
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Job Description:
The Compliance Manager will be responsible for routine to moderately complex elements of AbbVie's compliance program related to Research & Development.

Key Responsibilities include:

  • Partners with all levels of key business functions to provide routine to moderately complex OEC and functional policy interpretation and provide guidance on the requirements.
  • Conducts compliance risk assessments, trend analyses and provides recommendations for compliant and best practice business activities.
  • Conducts routine to moderately complex policy and procedure reviews and updates related to OEC policy and functional procedures ensuring clarity, applicability and compliance.
  • Develops, delivers and updates OEC's comprehensive training program on routine to moderately complex OEC and functional policies and procedures, including the Operating Procedures for Program Funding and AbbVie's Code of Business Conduct, as well as the current compliance environment.
  • Possesses working knowledge of AbbVie's business, the current compliance environment and the broader business impact.
  • Participates in and may lead cross-functional OEC projects.
  • Provides guidance on proposed business strategies and programs, identifies routine to moderately complex legal and regulatory issues, analyzes alternatives and works with legal and other functions, as appropriate, to propose solutions to the business.
  • Develops, implements, modifies, and oversees corporate and/or functional monitoring plans and any corrective actions to ensure compliance with policies and procedures.
  • Assists OEC Associate Director on compliance audits, when necessary, such as overseeing the fulfillment of auditors' requests and acting as a liaison between the business and auditors during on site activities. Expected to evaluate and help respond to moderate to complex preliminary audit findings and recommendations, and to guide the business in preparing corrective action(s) to address routine to moderately complex findings and recommendations, and work with the business to ensure timely completion.

Qualifications:

  • Bachelor's Degree required. CPA, Master's, JD, or equivalent work experience preferred.
  • Experience in clinical development including areas of Fair Market Value (FMV)/payments, clinical compliance, contracting, clinical trials/protocols and GCP preferred.
  • Minimum of 4 years experience with, or exposure to, business functions such as clinical compliance, legal, regulatory affairs, government affairs, and finance.
  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.
  • Learns, fast, grasps the 'essence' and can change the course quickly where indicated.
  • Raises the bar and is never satisfied with the status quo

Additional Information

  • Significant Work Activities and Conditions: N/A
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 11/15/2019

COMPLIANCE MANAGER, CORPORATE FUNCTIONS - AbbVie
Location: Lake County, IL USA


About AbbVie
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Job Description
Primary Job Function:

  • Provides timely and appropriate global compliance guidance for AbbVie business activities, including consultancies and contracting, grants and donations, sponsorship/exhibit/memberships, purchasing and finance.
  • Manages and tracks monitoring metrics/analytics, trends and observations for areas of responsibility. Develops and prepares periodic monitoring reports and presentations for leadership and/or stakeholder review. Closely collaborates with OEC Business, Training, Monitoring, and Brand support to ensure monitoring results are reviewed and corrective action(s), if necessary, are implemented.
  • Identifies, implements and manages systems, processes and applications to maintain or improve efficiency and effectiveness for areas of responsibility.
  • Works with Director of Transparency and AbbVie Legal to assess and interpret federal and state regulations, evaluate options and proposes solutions that includes monitoring compliance with specific state and federal reporting requirements.
  • Reviews and provides guidance on global potential conflicts of interest.
  • Serves as a resource and subject matter expert on various global policies and procedures.
  • Provides compliance support for and participates as a member of various AbbVie committees and councils.
  • Other special projects & responsibilities, as assigned.

Core Job Responsibilities:

  • Finds opportunities for improvement in AbbVie's business activities and processes and proactively drives and monitors implementation efforts.
  • Handles multiple projects simultaneously.
  • A high level of interpersonal skill is critical to the successful performance of this position. This involves creativity, originality and judgment as well as tact, diplomacy and the ability to instill confidence. Candidates should have the demonstrated ability to communicate effectively, present professionally, and work well with various levels within the organization.

Position Accountability / Scope:

  • Reports to OEC Associate Director.
  • Operates independently within well-defined expectations, checking in as necessary with supervisor(s).
  • Provides guidance and direction to all levels of the business as well as OEC personnel related to monitoring activities/results, as needed.
  • 5% travel

Basic:

  • BA/BS or equivalent work experience required.
  • 6+ years' experience with, or exposure to, business functions such as compliance, audit, legal, medical or regulatory affairs or finance.
  • Demonstrated strong communication skills, both written and verbal.
  • Previous pharmaceutical experience preferred.

Additional Information:

  • Significant Work Activities and Conditions: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 11/15/2019

ASSOCIATE DIRECTOR, COMPLIANCE - AbbVie
Location: Lake County, IL USA


About AbbVie
AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.

Job Description:
The Associate Director, Compliance possesses working knowledge of AbbVie's business, the current compliance environment and the broader business impact of compliance issues to develop and provide solution-oriented compliance guidance related to AbbVie's compliance program for the company's oncology therapeutic area.

Key Job Responsibilities:

The Associate Director, Compliance may perform the following with limited supervision from the Compliance Director, Oncology:

  • Serves as the compliance lead for at least one oncology brand team.
  • Partners with all levels of key business functions to provide Office of Ethics and Compliance (OEC) and functional policy interpretation and guidance on compliance requirements.
  • Conducts compliance risk assessments, trend analyses and provides solutions and recommendations for compliant business activities.
  • Provides guidance on proposed complex business strategies and programs, identifies legal and regulatory issues, analyzes alternatives and partners with other functions, as appropriate, to propose compliant business solutions
  • Leads cross-functional OEC programs and collaborates regularly with OEC colleagues to resolve issues and share learnings.

Key Leadership Competencies:

  • Builds strong relationships with peers and cross-functional partners outside of the team to enable higher performance
  • Learns fast, grasps the "essence" of issues and can change course quickly where indicated
  • Raises the bar and is never satisfied with the status quo
  • Deals comfortably with risk and ambiguity, makes high-quality decisions with less than perfect information
  • Manages conflict and difficult conversations across all levels of employees in a constructive, transparent way

Minimum Qualifications:

  • BA/BS required. JD, PharmD, MD, DO, RN and/or MBA encouraged.
  • Experience within pharmaceutical industry is preferred.
  • A minimum of 6 years' experience required with exposure to business functions such as compliance, legal, regulatory affairs, medical affairs and/or commercial.

Additional Information

  • Significant Work Activities and Conditions: N/A
  • Travel: Yes, 5 % of the Time
  • Job Type: Experienced
  • Schedule: Full-time

Equal Employment Opportunity Employer
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

 Apply here
Posted 11/15/2019

COMPLIANCE ANALYST - Karyopharm Therapeutics
Location: Newton, MA US
Job ID: 2019-1445
#of Openings: 1
Category: General & Administrative
Type: Regular Full-Time


Responsibilities
Karyopharm Therapeutics is looking for a high energy, detail-oriented candidate to join our Compliance team. The Compliance Analyst will be responsible for serving as the Executive Assistant to the Chief Compliance Officer and will provide supplemental coordination and support to other members of the Compliance and Legal team as required. Additionally, the Compliance analyst will support key Compliance initiatives and business processes including, but not limited to: tracking training assignments, creating and updating compliance dashboards, updating policies, developing training materials, event planning, transparency reporting, compliance campaigns and communications. The Compliance Analyst will be an integral part of the Compliance Team and will have an opportunity to attend/facilitate key meetings, work cross functionally, and attend conferences and seminars to enhance substantive expertise. This position will report to the Chief Compliance Officer, and will be located at our headquarters in Newton, MA.

Role Responsibilities:
The successful candidate will be highly experienced Executive Assistant who is ready for the opportunity to gain substantive compliance experience.

  • Supporting the development of training and meeting presentations
  • Creating and updating compliance dashboards
  • Managing compliance communications and newsletters
  • Developing systems and processes to track Compliance training
  • Completing expense reports and travel arrangements
  • Calendar Management
  • Preparing minutes and other documents for key meetings.
  • Working cross functionally to plan events and major meetings
  • Other tasks as assigned.

Qualifications:

  • Bachelor's Degree required.
  • Minimum of 5 years in an Executive Assistant role required
  • Expert Level Power-Point skills required
  • Strong General Computer Skills and common health care business systems (Word, Excel, SAP, Concur, Adobe Software) required
  • Excellent written and verbal communication skills required.
  • Pharmaceutical, Biotech or Medical Device industry experience preferred
  • Demonstrated resilience and ability to problem solve independently
  • Strong teamwork, collaboration and sense of urgency

Overview
Karyopharm Therapeutics is a global commercial-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases.

Karyopharm Therapeutics Inc. (the "Company") is an equal opportunity employer. All qualified applicants will be considered without regard to age, race, color, sex, religion/creed, national origin, marital status, ancestry, citizenship, military, reservist or veteran status, pregnancy, sexual orientation or preference, gender identity, gender expression, physical or mental disability, genetic predisposition or carrier status, or any other category protected under applicable federal, state or local law. Consistent with its obligations under applicable law, the Company will make reasonable accommodations for qualified individuals with disabilities. If you require an accommodation in the application process, please contact a member of the Company's Human Resources department.

 Apply here
Posted 11/12/2019

SENIOR MANAGER, ETHICS & COMPLIANCE MONITORING - Astellas
Location: Northbrook, IL


Astellas is announcing a Senior Manager, Ethics & Compliance Monitoring opportunity in Northbrook, IL.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Purpose & Scope:

The position plays a key role in Ethics & Compliance in support of the following:

  • The development, enhancement, and execution of risk-based compliance monitoring programs across a variety of Astellas-sponsored commercial and non-commercial live and transactional activities.
  • Planning and conducting risk assessments; executing data analytics; assisting the business with self-monitoring, assisting and/or preparing required presentations/reporting; conducting root cause analyses; developing and implementing strategies to address and mitigate identified risks.
  • Serving as a resource to support the development and enhancement of compliance monitoring programs in other Astellas affiliates.
  • Demonstrating good judgment and following organizational and professional ethical standards.

Essential Job Responsibilities:

  • Responsible for timely and accurate execution of risk-based compliance monitoring programs (live and transactional) across a variety of Astellas business activities, including activities conducted by the Astellas Commercial, Medical Affairs, and Research and Development organizations.
  • Under minimal supervision, develops and enhances testing criteria, ensures selection of appropriate monitoring samples, collects and analyzes relevant documentation, develops and documents monitoring observations, ensures the preparation and maintenance of appropriate monitoring workpapers, reporting and related documentation and communicates findings.
  • Executes, documents and reports on the risk mitigation activities, including developing and/or maintaining monitoring dashboards, issue tracking mechanisms, and related reporting tools.
  • Manages and tracks monitoring metrics, trends and observations. Develops and prepares periodic monitoring reports/presentations as necessary for E&C and business leadership, the US Compliance Committee, and other relevant stakeholders as appropriate.
  • Assists with the development and implementation of monitoring and remediation activities to enhance the overall efficiency and effectiveness of the compliance monitoring program and/or to meet regulatory and/or business requirements. This includes, but is not limited to, developing, enhancing and implementing monitoring activities (including expanded data analytic monitoring capabilities) as well as policies, procedures and processes.
  • Identifies, implements and manages systems/applications, solutions and other resources to enhance and maintain overall efficiency and effectiveness of the compliance monitoring program.
  • Assists in the training, development, management and oversight of compliance monitoring co-source partners.
  • Conducts risk assessments to identify, evaluate and prioritize the Company's potential risk areas, taking into account prior monitoring observations, identified and emerging risk areas, OIG guidance, industry trends, and past and planned business activities. Interviews business leaders and partners with internal stakeholders, including Internal Audit and Quality Assurance, to ensure communication and collaboration of auditing and monitoring plans.
  • Ensures that monitoring findings, observations and trends, as appropriate, are integrated into compliance and business policies, processes, training and communications to most effectively mitigate risk.
  • Serves as a monitoring resource to support the development, implementation and enhancement of E&C monitoring programs in other Astellas affiliates.

Quantitative Dimensions:

This position will evaluate and contribute to the improvement of business processes across a variety of Astellas commercial and non-commercial business activities through the development, execution and oversight of risk-based compliance monitoring programs. It will also assist in supporting Astellas with risk assessment and mitigation processes pertaining to the Corporate Integrity Agreement.

Organizational Context:

Position reports to the Director, Monitoring & Risk Mitigation who reports to the Executive Director, Healthcare Compliance & Risk Mitigation. Position works with all company functional/operational areas and employee levels in gathering, evaluating, and communicating information about the activity or processes being reviewed. This position will collaborate with various groups both within and outside of E&C

Qualifications:

Required:

  • BS /BA degree from an accredited college or university.
  • 7 + years of full-time experience in auditing and/or compliance monitoring.
  • Advanced level Excel skills (e.g., sumif, vlookup, hlookup, rank, count if, if statements, etc to be able to properly manipulate and report data).
  • Minimum of 3 years of relevant pharmaceutical/healthcare industry experience in a compliance, internal audit, or business consulting role.
  • Knowledge of pharmaceutical industry laws and regulations and related compliance issues.
  • Possesses a natural curiosity, strong orientation to detail and the ability to work in a fast-paced environment.
  • Demonstrated project management skills and the ability to work on multiple projects simultaneously with little supervision under tight deadlines.
  • Demonstrated initiative and problem-solving skills, including the ability to proactively identify issues and develop practical, meaningful solutions.
  • Demonstrated ability to exercise independent judgment, objectivity, handle confidential information with discretion and effectively collaborate with multiple functional units.
  • Demonstrated ability to interact with and present information to colleagues with the appropriate respect and sensitivity.

Preferred:

  • Prior supervisory experience.
  • Developed and/or assisted in the development/implementation of a compliance monitoring program within the pharmaceutical industry.
  • Professional / advanced degree or certification such as a MBA, JD or CPA.
  • Prior experience using a data analytics tool (e.g., Qlikview, Tableau).

 Apply here
Posted 10/24/2019

CORPORATE COMPLIANCE OPERATIONS SPECIALIST - Spark Therapeutics
Location: Philadelphia, PA, US
Date: Oct 3, 2019

Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Summary:
The Corporate Compliance Operations Specialist will analyze Healthcare Professional (HCP) and Healthcare organization (HCO) spend data and Compliance Monitoring assessments, policy and procedure development, and provide functional and technical support for Learning Management System (LMS), Aggregate Spend, and Monitoring software.

Responsibilities

25% Aggregate Spend and Transparency analysis:

  • Analyze HCP and HCO spend data from internal and external sources to ensure compliance with applicable federal and state reporting requirements and company policies
  • Analyze and reconcile individual payments or transfers of value to HCPs and HCOs to confirm data is complete, accurate and consistent, including review of Concur, Accounts Payable and third-party vendor data
  • Manage weekly remediation of payment data
  • Support testing and implementation of Aggregate Spend enhancements to various systems (e.g., CRM, accounts payable, purchase order systems)
20% Monitoring and Auditing analysis:

  • Analyze data from Monitoring tool to summarize observations and offer recommendations for monitoring plans and remediation
  • Analyze data from various sources (e.g., CRM, Concur, Aggregate Spend, Veeva) to aid Compliance and Internal Audit reviews and assessments of policy adherence
  • Conduct transaction auditing
  • Conduct live monitoring
  • Maintain and modify monitoring templates and checklists
20% Learning Management System:

  • Manage LMS assignments, updates, testing, and process improvements
  • Analyze and ensure data integrity including quality, accuracy, and functionality of training modules and system interfaces
  • Co-develop, review content and test new trainings for Compliance and other departments
  • Create guidelines and business process documentation
  • Recommend curricula improvements
20% Corporate Compliance Policies and Procedures:

  • Draft policies and procedures with input from SMEs
  • Coordinate review and approval of policies
  • Develop training solutions with vendors
  • Track and measure employee training on all Compliance policies
15% Background Screening, Fair Market Value administration, and other Compliance projects:

  • Conduct background screening for HCP services to Spark
  • Advise internal stakeholders with FMV calculations related to HCP services
  • Manage content for Compliance SparkSpace and SharePoint sites
  • Responsible for quarterly budget accruals
  • Maintain policy index and definitions including maintenance of documentation Compliance and company shared sites

Requirements:

  • Bachelor's degree required, advanced degree preferred.
  • Healthcare Compliance Certification a plus.
  • 8 - 10 years of experience in the biotech/biopharma/pharma industry with progressively responsible roles in analytics and customer management. Competencies
  • Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with creating analytical assessments in Microsoft PowerPoint® or other presentation formats. Proficiency in Microsoft Access® and Microsoft Excel®
  • Demonstrated analytical and problem-solving skills
  • Strong background with numerous industry standard and proprietary software solutions
  • Ability to work in a dynamic, fast-paced environment with shifting priorities
  • Working knowledge of, or ability to quickly become conversant with, various laws, regulations and industry guidance that affect Spark's Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, regulations regarding the promotion of marketed products, Open Payments EFPIA and the False Claims Act and Anti-Kickback Statutes)

 Apply here
Posted 10/17/2019

HEALTHCARE COMPLIANCE MANAGER / SENIOR SPECIALIST - Puma Biotechnology Inc.
Location: South San Francisco, CA

Permanent position in South San Francisco for a passionate pharmaceutical healthcare compliance professional who will have a critical role in development and building of a comprehensive and effective compliance program. This position reports to Director, Healthcare Compliance.

Summary/Objective
The Compliance Manager/Senior Specialist provides support for all elements of the comprehensive compliance program including conducting trainings and providing guidance to various teams, monitoring activities with significant risk, conducting investigations, reviewing needs assessment as well as partnering with business to ensure that all HCP transparency requirements are met. This role will support efforts to enhance compliance culture.


Essential Functions:

  • Support the implementation of the comprehensive compliance program under the direction of the Compliance Director.
  • Partner closely with various teams including Commercial, Field Employees, Sales Operations, Market Access and Medical Affairs and serve as a point of contact for compliance related questions.
  • Has an active role in the drafting, implementation and communication of Compliance-related policies and procedures.
  • Conduct compliance training, either in-person or online, on variety of compliance topics during New Hire Orientation, sales meeting, and any other supplemental training according to particular business need.
  • Assists in conducting compliance risk assessments as well as developing and supporting implementation of mitigation plans.
  • Supports compliance monitoring and audit efforts, conducts field monitoring, review data, draft reports and identify corrective actions.
  • Assists in investigations to the extent requested, including conducting reviews of documentation, conducting interviews and drafting reports
  • Monitor interactions with and payments to healthcare professionals. Work with various business partners and third party vendors to ensure HCP spend transparency reporting obligations are met on time.

Competencies:

  • Sound judgment, and strong commitment to ethical conduct and integrity.
  • Excellent interpersonal skills, able to work across different functions
  • Attention to detail, proficiency in Excel and ability to work with data
  • Good communicator, able to communicate in one on one or group setting.
  • Able to draft clear and effective reports, policies etc.
  • Project management skills. Ability to follow through and complete tasks on time with minimal supervision.

Other Duties:
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.

Required Education & Experience
Education:

  • Bachelor Degree or an Associate's Degree with relevant work experience

Experience:

  • Four to six years of experience related to implementing a compliance program with-in a business, or other complementary job experience (such as roles within Internal Audit, Finance or Legal functions).
  • Comprehensive working knowledge of applicable laws and industry guidance relating to healthcare and life science, and familiarity with the current life science marketplace

Additional Eligibility Qualifications:
Preferred Special Training:

  • Certification in healthcare compliance or auditing

Position Type/Expected Hours of Work
This is a full-time position. Days and hours of work are Monday through Friday, 8:30 a.m. to 5 p.m. This position may require some overtime work.

Work Environment
This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands
The physical demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.

The physical demands of the office are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel objects, tools or controls; reach with hands and arms; climb stairs; balance; stoop, kneel, crouch or crawl; and talk or hear. The employee must occasionally lift or move up to 25 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and the ability to adjust focus.

Travel
Travel is primarily local during the business day, although some out-of-area and overnight travel may be expected. Travel may be required (up to 15 %).

Equal Opportunity Employer
Our client is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, ethnicity, age, disability, veteran status, marital status, or any other characteristic protected by law.

 Apply here
Posted 10/16/2019

ASSOCIATE DIRECTOR, MEDICAL AND CLINICAL COMPLIANCE - Ferring Pharmaceuticals
Location: Parsippany, NJ

Job Description:
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of Reproductive Health (Infertility), Urology, Gastroenterology, Endocrinology, Women's Health (Obstetrics/Gynecology), Orthopedics, and Oncology. Ferring's US operations employ approximately 900 people.

People Come First at Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:
The Associate Director for Medical & Clinical Compliance will serve as the compliance lead to the Research, Clinical Development and Medical Affairs Departments. The Associate Director is responsible for created a risk-based compliance strategy, providing compliance direction and, training, in support of the organizations' medical affairs and clinical development related activities A key purpose is to ensure adherence with applicable Company policies and procedures as well as industry standards and best practices. Associate Director will act as the compliance leads for all medical and clinical initiatives from concept to implementation, including support of Medical Directors, Medical Science Liaisons (MSLs)/Outcomes Liaisons (OLs). Role will coordinate and draw on resources from other functions including the broader Compliance Department, and particularly other senior leaders in that function.

Responsibilities:

  • Provide sound compliance advice and guidance on non-promotional materials, scientific exchange, disease state, regulatory, medical/scientific programs and R&D activities to minimize company risk and facilitate compliance in alignment with applicable regulations.
  • Develop and execute an engagement and integration plan for US Compliance to incorporate requirements and training into all client groups, and vendors, involved with medical and scientific operations.
  • Create, implement and monitor an operational and effective compliance program for policies and procedures in a manner consistent with best practices and applicable laws and guidance.
  • Partner with the business support teams, including Legal, Regulatory, and Human Resources, to establish Compliance requirements and guidelines in support of non-commercial employees.
  • Provide input on Compliance matters to present to key stakeholders and senior leadership.
  • Foster a Company culture that focuses on Compliance and ensures on-going commitment to the Ferring Philosophy.
  • Develop and maintain SOPs, guidelines, policies and associated internal communication related to non-promotional, medical/clinical programs, including congress activity, clinical symposium, publications, reprints, medical information, advisory boards, ad hoc consulting, IITs, CTs, Mock FDA meetings, etc.
  • Liaise with Ferring Research facilities as well as Global non-commercial departments to ensure transparence and disclosure reporting and other relevant Compliance policies and processes are being communicated and being adhered.
  • Represent Compliance as the primary point of contact for the evaluation and implementation of SOPs and policies with Compliance impact and contribute to related standards and guidelines for the review of concepts and activities based on identified gap analyses and risks assessments or potential areas of Compliance vulnerability.
  • Act as the Compliance lead with all Medical, Scientific, Research and Development activities, including MSLs; from concept to field implementation and act as the primary Compliance authority on Corporate Contributions, Ed Grants, IITs, Delayed Publication, FIPCUS QA Committees other non-promotional Medical related and scientific team meetings.

Requirements:

  • 6+ years of pharmaceutical industry experience, with Compliance, Legal, Medical, or equivalent experience preferred
  • Bachelor's degree required
  • In depth understanding of PhRMA Code; Federal Food, Drug, Cosmetic Act; Anti-Kickback Statute; and federal and state transparency and disclosure laws.
  • Strong knowledge of industry compliance activities, regulatory landscape, pharmaceutical compliance training and monitoring programs.
  • Demonstrated experience and creating and delivering effective compliance training
  • Strong interpersonal skills, platform skills, and written and verbal communication skills
  • Experience involving the implementation of risked-based compliance programs and understanding of US pharmaceutical and other regulations.
  • Works well across multiple functions and therapeutic areas
  • Demonstrated ability to develop, launch, deliver, and measure various forms of training.
  • Proficient technology skills, etc.
  • Position requires excellent written and verbal communication, motivational, interpersonal and time management skills
  • Travel 20-30%

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com.

 Apply here
Posted 9/12/2019

ASSOCIATE DIRECTOR, PRIVACY - Ferring Pharmaceuticals
Location: Parsippany, NJ

Job Description:
Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with approximately 6,500 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology), orthopedics and Oncology. Ferring's US operations employ approximately 900 people.

People Come First at Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Responsibilities:

  • Develop and implement the Ferring Privacy program in the United States aligning with the overall Ferring Group Privacy Program and ensuring adherence with privacy legislation globally as well as applicable data protection laws, regulations and guidelines.
  • Developing and reviewing content for training materials, guidance documents and other communications to increase employee understanding of company privacy policies, data handling practices and legal obligations, as well as to ensure awareness of company privacy and data security issues via global and local communications plans.
  • Performing regular privacy assessments of business processes, providing practical and timely advice to internal clients to design processes in compliance with applicable data protection requirements, while protecting the company's integrity and reputation.
  • Managing process for responding to data subject requests and reports of potential data incidents (in compliance with Privacy Counsel and Litigation).
  • Overseeing monitoring/auditing plan for compliance with internal data protection policies and processes and working with Internal Audit function, Office of Business Integrity and Ethics or external auditors in carrying out plan.
  • Keeping abreast of privacy developments affecting clients (e.g., evolving guidance out of the European Union, California Privacy Act, discussions of US privacy laws, CAN-SPAM and e-privacy developments) and proactively anticipating potential changes needed to global privacy program to meet new regulatory requirements.
  • Develop and maintain standard operating procedures, guidelines, and policies in U.S. related to key areas of vulnerability within privacy and data protection.
  • Establish and facilitate activities to engage, educate, train, and inform U.S. organization about privacy issues, policies, and controls.
  • Performing regular privacy assessments of business processes, providing practical and timely advice to internal clients to design processes in compliance with applicable data protection requirements, while protecting the company's integrity and reputation.
  • Managing process for responding to data subject requests and reports of potential data incidents (in compliance with Privacy Counsel and Litigation).

Requirements:

  • Bachelor's degree required. Advanced degree or other privacy certification preferred;
  • Minimum of 5 years' experience providing privacy or related advice such as compliance, regulatory or IT, preferably to pharmaceutical, biotechnology, or medical device companies; legal background preferred but not required;
  • In-depth understanding of pharmaceutical compliance and privacy state laws.
  • Extensive knowledge of U.S. privacy and data breach laws and international privacy/data protection regulations. GDPR
  • Ability to effectively work across multiple functions/therapeutic areas;
  • Proficient computer skills: Word, Excel, Lotus Notes, Power Point, etc.
  • Position requires maturity, excellent communication (verbal/written) and presentation skills;
  • Certified Information Privacy Professional (CIPP), Certified Information Privacy Manager (CIPM), or equivalent professional

We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com.

 Apply here
Posted 9/12/2019

ASSOCIATE DIRECTOR, COMPLIANCE MONITORING & AUDITING - Jazz Pharmaceuticals
Category: Corporate
Country: United States
State: Pennsylvania
City: Philadelphia
Or may be based in Palo Alto, CA
Type: Regular Full Time
Job ID: 4504

Overview:
Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology – areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:
The Associate Director, Compliance Monitoring & Auditing is responsible for developing and executing against the Jazz Pharmaceuticals, Inc. (Jazz) annual compliance monitoring plan. This position will regularly monitor field activities, conduct monitoring and audits of company records and programs, execute against Jazz's Risk Assessment and Mitigation Process (RAMP) program, and have responsibility for remediation activities related to compliance findings and allegations of non-compliance with Company policy. The position will prepare dashboards, reports, and presentations summarizing monitoring and auditing findings and remediation for audiences ranging from Business Partners to Jazz Leadership.

Primary Responsibilities:

  • Develops and manages the annual compliance monitoring plan.
  • Conducts live field monitoring of Commercial and Medical Affairs activities.
  • Conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, and consulting and advisory engagements.
  • Prepares reports, presentations, and dashboards for numerous audiences, including Jazz Leadership, that summarize monitoring and auditing findings and remediation.
  • Supports Jazz's RAMP process and prioritizes monitoring activities and mitigation plans based on potential risks associated with Jazz's products and with applicable Federal health care program requirements.
  • Manages the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations and Jazz's Corporate Integrity Agreement.
  • Supports the development and enhancement of data analytics and use of innovative technology to expand and advance monitoring capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required by the Corporate Integrity Agreement, Open Payments, and state law monitoring and reporting.
  • Develops and maintains updated knowledge and understanding of Jazz's products, industry regulations and guidelines, and Company policies and standard operating procedures.
Required Knowledge, Skills, and Experience:

  • Minimum of 5 years' of healthcare compliance monitoring or auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry is required.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically PhRMA Code on Interactions with Healthcare Professionals is required.
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Jazz employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail-oriented.
  • Highest level of ethics and personal integrity.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.
Required/Preferred Education:

  • Bachelor's degree required.
Description of Physical Demands:

  • Position requires regular travel within the United States (estimated at ~40% per year);
  • Participation in ride-alongs' with field employees: one full day to multiple consecutive days;
  • Travel to participate at promotional programs: one hour to full day of attendance;
  • Travel to participate at external Conference, Congresses, and Industry events for 1-4 day periods;
  • Travel to Palo Alto office if needed to meet with business colleagues.
Description of Work Environment:

  • Work will be split between an office-based environment (~60%) and a field-based environment (~40%):
    • Work indoors will be in a normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
    • Work outdoors will require flight travel, overnight lodging, and extended period of time in a car
  • Frequent computer use in the field and office;
  • Responsibilities will require a work schedule that includes working outside of "normal" work hours while traveling in order to meet business demands;
  • Given the nature of work performed by the Compliance Department, Associate Director, Monitoring & Auditing may be asked to temporarily support other compliance related activities (e.g. CIA, compliance investigation(s), etc.) when necessary to meet a compliance obligation or firm [e.g. Government] deadline.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 9/10/2019

ETHICS AND COMPLIANCE PARTNER - UCB, Inc.
Location: Atlanta, Georgia

To strengthen our Ethics & Compliance team, we are looking for an Ethics & Compliance Partner

Are you an Ethics & Compliance expert looking to make an impact on the lives of patients?

As an Ethics & Compliance Partner you will work in an environment where you will:


Be the front-line representative of E&C organization, and represent E&C in a responsible and professional manner while acting as a strategic business partner.

This role is responsible for providing subject matter expertise and leadership on compliance-related matters within the organization, ensuring that the supported Patient Value organization is educated on Ethics & Compliance standards, informed about Ethics & Compliance related risks, helping minimize those, building Ethics & Compliance by design in their initiatives and guiding their personnel through global processes, connecting them with local stakeholders as needed.

This role will be responsible to oversee regional initiatives and connect with local Ethics & Compliance colleagues, ensuring appropriate flow of information; connecting with E&C peers through formal and informal collaboration networks to ensure consistent application of E&C approaches and efficient sharing of best practices.

As the Ethics & Compliance Partner you will contribute by:

  • Maintaining thorough knowledge of all industry codes, laws, regulations, and monitor key developments that would impact the business. In collaboration with colleagues, advise the business regarding existing and future provisions. For future provisions, ensure appropriate planning and preparation where it will impact the business.
  • Drive risk assessments for compliance in the supported organization, informed by adequate monitoring and analytics, ensuring that key stakeholders are informed on relevant risks and implementing remediation plans, in collaboration with E&C Leadership.
  • Supporting development of Policies and Procedures as a subject matter expert.
  • Working with the relevant stakeholders to ensure regional organizations are educated and well informed about ethics & compliance policies and procedures.
  • Acting as a proactive strategic partner with the business to help them meet their goals and objectives in a compliant manner, analyzing alternatives and proposing solutions.
  • Co-creating and collaborating on business initiatives to foster innovation and creation of meaningful solutions for patients while ensuring integrity and ethical principles are respected.
  • Actively engaging the supported organization leadership in driving the tone in integrity from the top and leveraging communication cascaded to the organization to maintain a high level of awareness in ethical business conduct.
Key Stakeholders:

  • Patient Value Units Regional and Missions' teams
  • Patient Value Practices teams
  • PVU/PVP Legal Counsels, Talent and Finance Partners
  • Ethics & Compliance Area/Affiliate teams
  • Ethics & Compliance PVU/PVP partners and Regional Head
Competencies & Proficiency:

  • Demonstrates curiosity and interest in the knowledge and experiences of colleagues.
  • Takes accountability for trying out new ideas and approaches.
  • Identifies and raises potential delays in project planning, plus their associated risks.
  • Builds, integrates and controls project planning, scheduling and resources.
  • Effectively communicates with local and regional stakeholders to have an aligned and approved project plan.
  • Propose ways of improvement in building and controlling project plans, in terms of accuracy and compliance risks.
  • Demonstrates and encourages generosity and helpfulness by sharing knowledge, skills and resources to optimize and improve outcomes.
  • Experience working in and being comfortable with matrix organization and reporting lines, and cross-functional teams without clear single leadership.
Interested? For this position you'll need the following education, experience and skills:

  • Bachelor's Degree/Master's Degree preferred
  • Minimum of 3 years of experience in the pharmaceutical industry.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.
  • Proficiency in Healthcare Compliance rules and regulations including self-regulated industry codes (PhRMA).
  • Experience in a transnational and multicultural environment.
  • Work effectively to design policies, management documents, presentations, control databases, KPI's, and dashboards.
 Apply here
Posted 8/30/2019