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Assoc Dir, US HCC Learning & Comm

Req #: 1700636
Location: Summit, NJ US
Job Category: Regulatory Affairs
Work Location: 86 Morris Avenue CELSUM 07901
Organization: Celgene Corporation
Schedule: 40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:US- NJ- Summit East

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

The Associate Director, US Healthcare Compliance Learning and Communications is responsible for strategic planning and execution of US HCC learning and communications for Hem/Onc and I&I Franchises (Commercial and Medical Affairs).  Designs, develops and provides live training to field and non-field US colleagues and supports International HCC team with live training execution on an as-needed basis. Also responsible for execution of US HCC communications strategy for all US based colleagues to facilitate awareness of the HCC Program and share learning across the organization.

Strategy & Planning -

  • Provides the critical and strategic thinking required to proactively plan and build the Healthcare Compliance (HCC) training program across the US organization and Globally as needed; and directly responsible for tactical implementation of the training program within the USA.  Partners with the International HCC team and Global Compliance Learning and Communication function to harmonize, where appropriate, on strategy, content and execution.
  • Utilizes results of risk assessments, new or updated local regulations, and updated internal policies or procedures, to assess training needs
  • Identifies areas of improvement on existing programs, recommends need for new policies, procedures, and training curriculum and implements enhancements or changes to ensure business compliance effectiveness.

Execution -

  • Develops and maintains all course content, audio/visual aids, handouts, learning aids, communications, as required to provide continued training tools and resources for shared materials
  • Provides live training to field and non-field US colleagues.
  • Provides live training on select Global training initiatives and “train the trainer” exercises.
  • Maintenance of all training programs/systems; creates, publishes and utilizes metrics and status reports to measure the effectiveness of the training program, including periodic training reports.

Communications –

  • Remains current and monitors sources of regulatory updates and industry best practices, including but not limited to US enforcement activity trends, Spend Transparency laws / codes, applicable US
  • laws and codes, and disseminates necessary information to affected business partners and/or incorporates into training content updates and training program.
  • Enhances the culture of integrity and compliance by leading efforts with Global Corporate Communications and Global Compliance teams to develop and deliver HCC communications to promote continued awareness.

Establishes and develops relationships with business leaders, including but not limited to commercial, medical, regulatory, legal and compliance to drive the HCC US training strategy implementation and execution.

Key Requirements:

  • Minimum 5 years of experience in pharma/ biotech related to development of training programs, curriculum development, and learning management systems; relevant experience from other industries will also be considered.
  • Passionate about Adult Learning principles and well-versed in latest techniques, tools and technology to advance adult learning objectives in today’s tech-savvy and fast-paced environment.
  • Experience in identifying, developing and executing novel approaches to content delivery.
  • Proven ability to develop training materials, conducting workshops, classroom, and remote/online training
  • Knowledge and experience developing a complex US strategic training program
  • Knowledge in developing and executing strategic communication plans
  • Ability to research, develop, write, and effectively communicate information within a health care compliance environment
  • Knowledge of US laws, regulations, industry guidance and best practices regarding compliant sales, marketing, and medical activities
  • Understanding of process for defining and implementing policies, procedures and SOP’s
  • Working with cross-functional teams
  • Ability to work independently to build and execute training program
  • Ability to work with cross-functional teams and partners
  • Excellent verbal, written, presentation, and other communication skills
  • Ability to fully engage various audiences
  • Proficiency in Microsoft Office is required
  • Proficiency in learning management systems
  • Must be self-motivated and possess strong interpersonal skills

Competencies:

  • Documentation management
  • Highest level of integrity and able to protect confidential information
  • Subject matter knowledge of healthcare compliance
  • Negotiation, collaboration, persuasion, communication and relationship building skills
  • Role model for ethical behaviour
  • Multi-tasking
  • Ability to work in a highly matrixed organization
  • Personal and professional maturity
  • Ability to prioritize
  • Time management skills
  • Ability to work independently

PREREQUISITES:

  • Bachelor degree; advanced degree - preferred 
  • Fluency in English
  • Compliance and regulatory knowledge in related commercial or medical functions
  • Minimum of 10 years training experience
  • Minimum of 7 years of experience and demonstrated leadership in HCC or related compliance function (HCC, Privacy, regulatory, quality, legal) - preferred
  • Minimum of 3 years of line management experience in the pharmaceutical and/or medical device industries - preferred

#LI-POST

Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.
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