Senior Manager, GPS Programs & Digital Assets

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

General Description:

This position is responsible for creating and maintaining the oversight of BeiGene’s Post Marketing Organized Data Collection Program (PMODCP) and BeiGene sponsored digital asset/ social media programs (hereinafter collectively referred as “Programs” below) to ensure all pharmacovigilance activities required in such Programs are performed in an efficient, consistent and compliant manner. The position requires an experienced and confident manager who can collaborate with multiple stakeholders internally and externally ensure compliance and high-quality standards.

Essential Functions of the Job:

• Create and maintain the overview of BeOne Programs, such as Patient Support Programs, Market Research programs, Expended Access Programs, company websites or social media platforms for PV purposes.
• Collect detailed Program information from Business Owners 
• Conduct the program design review, especially the data collection tool review to be used in the Programs to estimate the possibility of receiving safety information and to ensure PV requirements are included in the Program design and documents
• Serve as liaison for GPS and business owners for programs and facilitate necessary discussion
• Provide guidance and support to Program teams for PV matters
• Support Business Owners functions, such as Medical Affairs, Commercial, or Marketing in the development of processes, forms, and/or training for the Programs
• Support review of the contracts with third parties for the Programs
• Generate Program Identification Number for each Program and notify the assigned Program Identification Number to GPS functions, Business owners and Business Partners
• Send Program notification regarding new program, change of program and termination of programs to stakeholders for PV activities initiation and implementation
• Support facilitating training to contract partners for the Programs
• Responsible for coordination of day-to-day PV activities for the programs, provide PV operation support if necessary
• Collaborate with GPS functions to ensure alignment among case intake, submission, reconciliation training and any other PV activities
• Conduct and coordinate PV close-up activities when each program is completed 
• Responsible for maintaining a tracker for the Programs
• Support PSMF update by providing Program information to PSMF team in an agreed format
• Work cross functionally with Quality Assurance functions for inspection and audit matters regarding the Programs.
• Participate in the development and maintenance of PV policies, SOP and guidance documents for the Programs to ensure compliance with all applicable regulatory requirements or guidelines, GVP and industry best practices
• Look for opportunities to improve and optimize the current processes
• Escalate issues to GPS management as needed

Supervisory Responsibilities:  

N/A

Computer Skills:   

• Proficient in standard computer software (Word, Excel and Power point presentations)

Other Qualifications:    

• 7+ years of medical, scientific, including direct pharmacovigilance experience
• Knowledge of GCPs, ICH guidelines and FDA, EMA, and other international regulations and guidelines
• Experience with onboarding, overseeing and managing business partners
• Strong interpersonal and communication skills; proactive approach. Able to work both independently and in a team environment
• Detail-oriented, with good organizational, prioritization, and time management proficiencies. Must be able to work on multiple projects simultaneously
• Demonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.

Education Required:

7+ years' experience with Bachelors/Advanced degree preferably in life science, nursing, pharmacy or other healthcare related profession (RN, PharmD, NP, PhD, MPH, etc.)

Travel:  0-10%

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process.  Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.

We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].