Celgene Senior Manager, US Healthcare Compliance, Policy in Summit, New Jersey
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
Summary / Scope:
Develop and author, maintain, and revise US HCC related procedures (SOPs), guidance and other controlled documents. Responsible for being subject matter expert in process design; driving efficiency, and designing controls to mitigate risk. Collaborate and partner with key stakeholders to ensure appropriate and timely implementation of such procedures. Partner with other Compliance colleagues to identify areas of opportunity for continuous improvement of process and written procedural documents.
Responsibilities include, but are not limited to:
Identify need for written procedural documents (in anticipation of need and in response to need) with primary focus on development and enhancement of implementing SOPs related to Corporate Policy requirements
Identify who will take lead responsibility for procedural development (individual, working group, sub-committee, etc.)
Gather background information, coordinate/author draft procedure, consult with stakeholders, finalize and secure approvals
Assure efficient implementation
Monitor, review and revise as necessary.
Bachelor degree; advanced degree - preferred
•Compliance and regulatory knowledge in related commercial or medical functions
•Minimum of 10 years Policy/Procedure development experience (or equivalent)
•Global cross-functional and/or cross-sector experience - required
•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
Key Requirements :
Minimum 10 years of experience in pharma/ biotech related to development of procedural documents and/or Quality Management Systems in general
Proven ability to develop procedural documents, conduct workshops, classroom, and remote/online communications.
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 and partners
Ability to work independently to build and execute SOP development program
Excellent verbal, written, presentation, and other communication skills
Proficiency in Microsoft Office is required
Must be self-motivated and possess strong interpersonal skills
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
Ability to work in a highly matrixed organization
Personal and professional maturity
Ability to prioritize
Time management skills
Ability to work independently
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.
Senior Manager, US Healthcare Compliance, Policy
Location: Summit, NJ, US
Job ID: 17001044