... Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a ...
49 Beigene Quality Assurance Associate Jobs Hiring Near You
... Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a ...
Biotechnician I (Hopewell, NJ)
Hopewell, NJ · On-site
$25.48/hr
Performing in-process visual inspection for quality assurance * Labeling and packaging of finished drug product in compliance with cGMP * Completing batch documentation and reviewing records for ...
Biotechnician I (Hopewell, NJ)
Hopewell, NJ · On-site
$25.48/hr
Performing in-process visual inspection for quality assurance * Labeling and packaging of finished drug product in compliance with cGMP * Completing batch documentation and reviewing records for ...
Internal Auditor
Cambridge, MA · On-site
Support any additional assignments or special projects as required, including but not limited to External/Internal Quality Assessment, Quality Assurance and Improvement Program (QAIP) and audit ...
Internal Auditor
Cambridge, MA · On-site
Support any additional assignments or special projects as required, including but not limited to External/Internal Quality Assessment, Quality Assurance and Improvement Program (QAIP) and audit ...
Associate Director, Maintenance & Facilities
Pennington, NJ · On-site
$16.25 - $22.25/hr
BeOne Medicines is seeking highly motivated and organized Associate Director Maintenance to join ... Strong understanding of Quality in GMP environment including Good Documentation Practices ...
Associate Director, Maintenance & Facilities
Pennington, NJ · On-site
$16.25 - $22.25/hr
BeOne Medicines is seeking highly motivated and organized Associate Director Maintenance to join ... Strong understanding of Quality in GMP environment including Good Documentation Practices ...
The Global Commercial and Medical Affairs Technology team at BeOne is seeking an Associate Director ... The role will focus on improving data quality, reducing manual processes, enhancing system ...
The Global Commercial and Medical Affairs Technology team at BeOne is seeking an Associate Director ... The role will focus on improving data quality, reducing manual processes, enhancing system ...
Senior Clinical Research Associate
$105K - $140K/yr
The Senior Clinical Research Associate (SCRA) is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient ...
Senior Clinical Research Associate
$105K - $140K/yr
The Senior Clinical Research Associate (SCRA) is primarily a site monitor and is responsible for the management and oversight of their assigned clinical study sites to ensure data quality and patient ...
... quality, timely completion of regulatory deliverables. This individual will provide leadership and ... The Associate Director will also manage regulatory aspects of compounds through all phases of ...
... quality, timely completion of regulatory deliverables. This individual will provide leadership and ... The Associate Director will also manage regulatory aspects of compounds through all phases of ...
Associate Director, Global Program Management
$148K - $198K/yr
... GPM) Associate Director/Director is accountable for the lifecycle management of drug development ... Champion and support process improvement initiatives and optimize efficiency, quality and ...
Associate Director, Global Program Management
$148K - $198K/yr
... GPM) Associate Director/Director is accountable for the lifecycle management of drug development ... Champion and support process improvement initiatives and optimize efficiency, quality and ...
The Associate Director, Enterprise Information Architecture will play a key role in shaping and ... Support the adoption of AI/ML and Generative AI by enabling high-quality, well-governed, and AI ...
The Associate Director, Enterprise Information Architecture will play a key role in shaping and ... Support the adoption of AI/ML and Generative AI by enabling high-quality, well-governed, and AI ...
Associate Director, Advanced Analytics, Patient Journey Insights and Predictive Modeling
$60K - $60K/yr
... quality insights, build scalable predictive models, strengthen data and model governance, and embed analytics into strategic and operational decision-making. Key Responsibilities Patient Journey ...
Associate Director, Advanced Analytics, Patient Journey Insights and Predictive Modeling
$60K - $60K/yr
... quality insights, build scalable predictive models, strengthen data and model governance, and embed analytics into strategic and operational decision-making. Key Responsibilities Patient Journey ...
Provides management to Global Study Management Associates (gSMAs) at various levels in one or ... Ensures that gSMAs' supporting task delivery meets appropriate inspection readiness quality ...
Provides management to Global Study Management Associates (gSMAs) at various levels in one or ... Ensures that gSMAs' supporting task delivery meets appropriate inspection readiness quality ...
The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader ... and quality standards are met globally. Cross-Regional Collaboration * Build partnerships with ...
The Associate Director, Global Regulatory Project Management (AD, Global RPM) is a strategic leader ... and quality standards are met globally. Cross-Regional Collaboration * Build partnerships with ...
The Associate Director, Brand Analytics is strategic analytics partner responsible for supporting ... Manage projects effectively across multiple stakeholders, ensuring timely delivery, high quality ...
The Associate Director, Brand Analytics is strategic analytics partner responsible for supporting ... Manage projects effectively across multiple stakeholders, ensuring timely delivery, high quality ...
The Associate Director, Clinical Supply Chain Sourcing Strategy and Innovation is responsible for ... Knowledge of regulatory, quality, GxP, import/export, and global supply chain requirements ...
The Associate Director, Clinical Supply Chain Sourcing Strategy and Innovation is responsible for ... Knowledge of regulatory, quality, GxP, import/export, and global supply chain requirements ...
Associate Director, Field Tools will serve as a strategic partner for Commercial and Medical ... through quality assurance testing, assisting in user acceptance testing and review of various ...
Associate Director, Field Tools will serve as a strategic partner for Commercial and Medical ... through quality assurance testing, assisting in user acceptance testing and review of various ...
Associate Director, Clinical Supply Chain
$138K - $188K/yr
Clinical Operations, Regulatory, Quality, CMC). • Provide managerial support to employees with the overall responsibility of leading, training, and mentoring for effective performance. • Work ...
Associate Director, Clinical Supply Chain
$138K - $188K/yr
Clinical Operations, Regulatory, Quality, CMC). • Provide managerial support to employees with the overall responsibility of leading, training, and mentoring for effective performance. • Work ...
Director, Regional Clinical Study Management
$171K - $231K/yr
Provides leadership to the team of Associate Directors, Operations Managers and Operations ... Quality Line management responsibilities: * Ensures team members are trained on and are adhering to ...
Director, Regional Clinical Study Management
$171K - $231K/yr
Provides leadership to the team of Associate Directors, Operations Managers and Operations ... Quality Line management responsibilities: * Ensures team members are trained on and are adhering to ...
Associate Director, Medical Writer - Publications
$143K - $193K/yr
Adhere to industry-standard guidelines as well as BeOne SOPs, work instructions, and quality standards * Establish and maintain professional relationships with internal colleagues, external authors ...
Associate Director, Medical Writer - Publications
$143K - $193K/yr
Adhere to industry-standard guidelines as well as BeOne SOPs, work instructions, and quality standards * Establish and maintain professional relationships with internal colleagues, external authors ...
Associate Director, Biostatistics
$162K - $212K/yr
Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. * Collaborates with the statistical programming staff to ensure that ...
Associate Director, Biostatistics
$162K - $212K/yr
Participates in database design meetings to ensure that the data evaluated are in high quality and satisfy analysis requirements. * Collaborates with the statistical programming staff to ensure that ...
Associate Director, Strategic Planning and Operations, Office of the CMO, Solid Tumors
$143K - $193K/yr
Associate Director, Strategic Planning and Operations, Office of the CMO, Solid Tumors will report ... efficiency, quality, and performance. Essential Functions of the Job: * Lead initiatives and ...
Associate Director, Strategic Planning and Operations, Office of the CMO, Solid Tumors
$143K - $193K/yr
Associate Director, Strategic Planning and Operations, Office of the CMO, Solid Tumors will report ... efficiency, quality, and performance. Essential Functions of the Job: * Lead initiatives and ...
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Part-time
Medical, Dental, Vision, Life, Retirement, PTO
Re-posted 10 days ago
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.
General Description/Scope of Responsibilities (Internship):
BeOne is seeking a motivated and talented individual to join our Reg CMC small molecule team which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey.
The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing to process optimization in knowledge management. Specifically, the intern will:
Essential Functions of the Internship:
Supervisory Responsibilities:
Computer Skills: Proficient in Microsoft Office
Education Required: Active enrollment (Graduate or Ph.D.) in an accredited college or university pursing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum 3.0 GPA
Other Qualifications:
Travel: None
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: $ - $ per hour
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.
General Description/Scope of Responsibilities (Internship):
BeOne is seeking a motivated and talented individual to join our Reg CMC small molecule team which offers meaningful project experiences that gives interns the opportunity to gain valuable Biotech experience as they complete their academic journey.
The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality Assurance, Supply Chain, CMC, and IT. The focus of the internship is for the intern to develop a deeper understanding of the drug development process and regulatory requirements in a professional work environment, while contributing to process optimization in knowledge management. Specifically, the intern will:
- Be exposed to the broad scope of global Regulatory Affairs and specifically CMC Regulatory Affairs and the role's contribution to drug development and patients' access to medicines.
- Learn about the role of global Health Authorities in the drug development process.
- Gain hands-on experience in preparing regulatory documents for submission to global health authorities.
- Acquire knowledge about the differences in regulatory requirements across regions.
- Experience CMC technical product development and manufacturing functions in relation to regulatory affairs.
Essential Functions of the Internship:
- Responsible for maintaining accurate CMC information in the BeOne Regulatory Information Management system
- Data remediation
- Create and maintain CMC Submission Content
- Upload HA Correspondence/HA Questions/Commitments
- Maintain internal Regulatory CMC trackers
- Contribute to Reg CMC process improvements
- Support the drafting of CTD CMC sections to ensure on-time and high-quality global applications for direct submission to Health Authorities as needed.
- Provide support to Reg CMC team or hiring manager with Regulatory submissions and other tasks as needed
Supervisory Responsibilities:
- No
Computer Skills: Proficient in Microsoft Office
Education Required: Active enrollment (Graduate or Ph.D.) in an accredited college or university pursing a degree in a scientific discipline (e.g., life sciences, chemistry, biology, biotechnology, materials science, etc.) with a minimum 3.0 GPA
Other Qualifications:
- Awareness of processes for working in a regulated field preferred
- Basic knowledge of healthcare industry and strong passion for biotech
- Legally authorized to work in the United States without needing sponsorship for employment now or in the future
- Ability to work independently on assignments with routine check-ins
- Strong written and oral communication skills
- Organized, responsible, resourceful, and detail-oriented
- Able to work in a cross-cultural team environment with members across different time zones
- Able to work remotely using MS TEAMS and other collaboration tools
Travel: None
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: $ - $ per hour
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