... global safety operations activities; oversee effective collection, processing, assessment and ... Ensure that management, flow, & distribution of safety data is globally consistent * Oversee data ...
60 Beigene Operations Manager Jobs Hiring Near You
... global safety operations activities; oversee effective collection, processing, assessment and ... Ensure that management, flow, & distribution of safety data is globally consistent * Oversee data ...
This position reports directly to the Manager of Drug Product and requires effective leadership ... Finish operations. The Drug Product Supervisor will be responsible for actively directing and ...
This position reports directly to the Manager of Drug Product and requires effective leadership ... Finish operations. The Drug Product Supervisor will be responsible for actively directing and ...
Director, Regional Clinical Study Management
$171K - $231K/yr
Provides leadership to the team of Associate Directors, Operations Managers and Operations Associates in charge of regional study management, including mentoring, coaching and managing performance.
Director, Regional Clinical Study Management
$171K - $231K/yr
Provides leadership to the team of Associate Directors, Operations Managers and Operations Associates in charge of regional study management, including mentoring, coaching and managing performance.
Intake & Triage Management * Serve as the primary operational point of contact for BD-initiated opportunities. * Manage the intake process, ensuring complete and consistent information capture.
Intake & Triage Management * Serve as the primary operational point of contact for BD-initiated opportunities. * Manage the intake process, ensuring complete and consistent information capture.
Be the end to end GTS solution manager of key Treasury applications ranging from operational run activities to solution improvements * Partner with business and other solution managers to develop the ...
Be the end to end GTS solution manager of key Treasury applications ranging from operational run activities to solution improvements * Partner with business and other solution managers to develop the ...
Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling ... Ensures efficient and effective day-to-day operations of the Microbiology laboratory. Essential ...
Manages all QC Microbiology Environmental Monitoring (EM) as well as the utilities sampling ... Ensures efficient and effective day-to-day operations of the Microbiology laboratory. Essential ...
Manager, Small Molecule Packaging
Pennington, NJ · On-site
$110K - $150K/yr
Operations & Production * Lead day-to-day operation of bottle filling, capping, labeling, cartoning, and case packing processes * Ensure packaging line meets throughput, schedule, and quality targets
Manager, Small Molecule Packaging
Pennington, NJ · On-site
$110K - $150K/yr
Operations & Production * Lead day-to-day operation of bottle filling, capping, labeling, cartoning, and case packing processes * Ensure packaging line meets throughput, schedule, and quality targets
Leads the regional clinical operations team (including external partners working on a regional ... Generates, manages, and maintains high quality study start up and recruitment timelines for region ...
Leads the regional clinical operations team (including external partners working on a regional ... Generates, manages, and maintains high quality study start up and recruitment timelines for region ...
Leads the regional clinical operations team (including oversight of external partners working on ... Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics ...
Leads the regional clinical operations team (including oversight of external partners working on ... Works with integrity and ethically in accordance with BeiGene's Code of Business Conduct and Ethics ...
Senior Manager Packaging Engineering (Hopewell, NJ)
Hopewell, NJ · On-site
$141K - $186K/yr
Utilization of standard processes in commercial development and lifecycle management of BeOne products in alignment with the overall manufacturing/packaging capability of BeOne operations at the ...
Senior Manager Packaging Engineering (Hopewell, NJ)
Hopewell, NJ · On-site
$141K - $186K/yr
Utilization of standard processes in commercial development and lifecycle management of BeOne products in alignment with the overall manufacturing/packaging capability of BeOne operations at the ...
... operations and corporate goals and objectives • Experience in managing global oncology studies; preferably pivotal studies and inspection management with Hiring Authority. Essential Functions of ...
... operations and corporate goals and objectives • Experience in managing global oncology studies; preferably pivotal studies and inspection management with Hiring Authority. Essential Functions of ...
Ensures efficient and effective day-to-day operations of the CE laboratory. This position reports to the Senior Manager QC and is located full-time at the Hopewell, NJ site. Essential Functions of ...
Ensures efficient and effective day-to-day operations of the CE laboratory. This position reports to the Senior Manager QC and is located full-time at the Hopewell, NJ site. Essential Functions of ...
Senior Manager, Finance, External Manufacturing
Pennington, NJ · On-site
$110K - $149K/yr
We are seeking a Senior Finance Manager - External Manufacturing to join our Global Tech Ops ... Provide actionable insights and clear financial narratives to support operational decision-making.
Senior Manager, Finance, External Manufacturing
Pennington, NJ · On-site
$110K - $149K/yr
We are seeking a Senior Finance Manager - External Manufacturing to join our Global Tech Ops ... Provide actionable insights and clear financial narratives to support operational decision-making.
Senior Manager, Global Strategic Feasibility
$118K - $119K/yr
The Senior Manager supports and coordinates high-quality strategic feasibility and site ... Provides operational feasibility insights to inform study design considerations and optimization ...
Senior Manager, Global Strategic Feasibility
$118K - $119K/yr
The Senior Manager supports and coordinates high-quality strategic feasibility and site ... Provides operational feasibility insights to inform study design considerations and optimization ...
Senior Project Manager, Clinical Biomarker
$140K - $185K/yr
Manage biomarker related operational work for clinical trials and programs. Act as biomarker operation representative to lead/participate in cross-functional activities and initiatives. Act as key ...
Senior Project Manager, Clinical Biomarker
$140K - $185K/yr
Manage biomarker related operational work for clinical trials and programs. Act as biomarker operation representative to lead/participate in cross-functional activities and initiatives. Act as key ...
Senior Associate, Regulatory Affairs, Promotional Operations
$93K - $123K/yr
Drives the process within the document management system (Veeva PromoMats) for review and management of promotional materials. * Works in partnership with Global Regulatory Operations to prepare ...
Senior Associate, Regulatory Affairs, Promotional Operations
$93K - $123K/yr
Drives the process within the document management system (Veeva PromoMats) for review and management of promotional materials. * Works in partnership with Global Regulatory Operations to prepare ...
This role oversees the ServiceNow platform, global service desk operations, executive support, ITSM processes, service governance, automation, experience management, and performance accountability as ...
This role oversees the ServiceNow platform, global service desk operations, executive support, ITSM processes, service governance, automation, experience management, and performance accountability as ...
Director, Head of Patient Recruitment and Retention, Americas
$171K - $231K/yr
... Management and Operations Management. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global ...
Director, Head of Patient Recruitment and Retention, Americas
$171K - $231K/yr
... Management and Operations Management. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global ...
Develop and systematically manage stakeholder relationships across HR and other business functions to ensure procurement strategies are aligned with operational needs and company goals. * Category ...
Develop and systematically manage stakeholder relationships across HR and other business functions to ensure procurement strategies are aligned with operational needs and company goals. * Category ...
... Manager. This role is responsible for driving and managing key cross-functional projects across ... growth and operational excellence. This individual will actively embed within key strategic ...
... Manager. This role is responsible for driving and managing key cross-functional projects across ... growth and operational excellence. This individual will actively embed within key strategic ...
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Full-time
Medical, Dental, Vision, Life, Retirement, PTO
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Job description
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.
As part of the Global Patient Safety (GPS) leadership team, this role is to ensure end-to-end execution, quality and continuous improvement of global safety operations activities; oversee effective collection, processing, assessment and reporting of ICSRs against global standards; oversee safety operations activities in clinical trials, as well as China PV activities, oversee safety systems and reporting activities and actively influence GPS' operational technology strategy and provide broad and deep technical knowledge.
This role supports and contributes to internal GPS department development and liaises cross-functionally to execute on PV responsibilities.
Essential Functions of the job:
ICSR Activities Oversight
Trial Safety Operations
China Post Marketing Safety Operations
Supervise China PV responsible person for MAH and DRE, ensuring that the operation and continuous improvement of the pharmacovigilance system to meet the requirements of relevant laws and regulations in China. The main responsibilities of this person are applicable to China include:
Safety Systems and Reporting
Internal Global Patient Safety Dept Development and Liaison with Other Functions
Supervisory Responsibilities:
Computer Skills:
Education Required:
Other Qualifications:
Travel: International and domestic, up to 20%
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.
Salary Range: $285,800.00 - $365,800.00 annually
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 accommodationsus@beonemed.com.
As part of the Global Patient Safety (GPS) leadership team, this role is to ensure end-to-end execution, quality and continuous improvement of global safety operations activities; oversee effective collection, processing, assessment and reporting of ICSRs against global standards; oversee safety operations activities in clinical trials, as well as China PV activities, oversee safety systems and reporting activities and actively influence GPS' operational technology strategy and provide broad and deep technical knowledge.
This role supports and contributes to internal GPS department development and liaises cross-functionally to execute on PV responsibilities.
Essential Functions of the job:
ICSR Activities Oversight
- Oversee development & systematic improvement of safety data collection methods
- Ensure that management, flow, & distribution of safety data is globally consistent
- Oversee data convention standards within the database
- Ensure ICSR submissions to all destinations in compliance with regulation and PV agreements
Trial Safety Operations
- Ensure appropriate representation of SAE data for inclusion in safety-related reports in clinical trials
- Ensure compliance of safety operations activities in clinical trials
- Ensure effective liaison with internal & external stakeholders to operationalize and optimize process related to safety reporting including such as Trail Master File (TMF) plan and Safety Management Operation plan
China Post Marketing Safety Operations
Supervise China PV responsible person for MAH and DRE, ensuring that the operation and continuous improvement of the pharmacovigilance system to meet the requirements of relevant laws and regulations in China. The main responsibilities of this person are applicable to China include:
- Ensure compliance of adverse drug reactions monitoring and reporting
- Oversee the identification, assessment and control of drug safety risks and ensure the effective implementation of risk control measures
- Be responsible for the management of drug safety information communication and ensure timely and effective communication
- Ensure smooth communication channels within the internal stakeholders and business partners, as well as the drug regulatory authorities and the drug adverse reaction monitoring authorities
Safety Systems and Reporting
- Oversee Safety database, Safety Reporting, and other associated safety gateways and data repositories
- Support technical activities and documentation for all safety systems working with other technology teams
- Oversee development and implementation of PV technology strategies and projects
- Enhance PV technology footprint within GPS in collaboration with cross departments and in alignment with organizational objectives
- Develop budget and investment strategies for new technology capabilities to support PV
Internal Global Patient Safety Dept Development and Liaison with Other Functions
- Create resource requirement projections for safety operations
- Recruit, retain, develop, and mentor safety operations staff
- Create, sign off and maintain policies, guidelines, and SOPs from safety operations perspective
- Contribute to Compliance Forum and Process & Standards Forum
- Contribute to audits and inspections
- Support the development & realization of the GPS department's vision and long-range plan
- Participate in the review of pharmacovigilance agreements and oversee PV agreement execution from safety operations perspective
- Support outsourcing / vendor selection strategies and relationships from safety operations perspective
Supervisory Responsibilities:
- As Function head, leads GPS Safety Operations Team: Global ICSR Management, Global ICSR Submission, Trial Safety Operations, China Post Marketing Safety Operations, Safety Systems and Supporting
Computer Skills:
- Proficiency with Microsoft office
- Proficiency in technical safety systems including ARGUS and data convention
Education Required:
- MD, PharmD., RN plus higher degree or international equivalent, or the equivalent combination of relevant education or professional experience
Other Qualifications:
- Mastery of global safety regulatory requirements
- Fifteen (15) years relevant experience, including training
- Ten (10) years drug safety experience
- Proficiency in safety report processing & operational systems
- Proficiency of signal recognition, statistical techniques & trials methods & outputs
- Previous management experience
- Process and systems management experience preferred
- Clinical experience preferred
Travel: International and domestic, up to 20%
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
Salary Range: $285,800.00 - $365,800.00 annually
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 accommodationsus@beonemed.com.
About BeiGene
Sourced by ZipRecruiter
BeiGene (NASDAQ: BGNE; HKEX: 06160; SSE: 688235) is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,200 colleagues across five continents. For more information, please visit www.beigene.com .
Industry
Health care and social assistance
Company size
5,001 - 10,000 Employees
Headquarters location
Cambridge, MA, US
Year founded
2010