AddressBeiGene 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.
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About BeiGene:
BeiGene (NASDAQ: BGNE; HKEX: 06160; SHA: 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 trial candidates, we are committed to expediting the development of our diverse pipeline of novel therapies through collaborations or our own internal capabilities, with the aspirational goal of radically improving access to medicines for billions more people by 2030. BeiGene is a headquarter-less company by design, with a growing global team of over 10,000 colleagues across five continents.
About the Position:
Support in shaping the external GxP environment (policy / advocacy work) on GxP regulatory requirements and expectations in conjunction with representing the BeiGene in various external organizations (e.g. PDA, ISPE, ICH). This also entails being knowledgeable about current evolving issues and topics impacting the BeiGene's GxP Operations globally and providing assessment, analysis and communication back into the organization through established channels and representing the company's approved positions externally. Work internally to gather needs and encourage support and scientific knowledge on external issues including the needs on competitive intelligence.
Essential Functions of the job:
- Establish and maintain a program for GxP intelligence that ensures BeiGene remains compliant with external regulatory and industry trends and regulations (both draft and effective); triage, prioritize, assess, respond, project manage and implement relevant regulations by partnering with internal SMEs and process teams
- Influence and shape global GxP regulatory and Quality policy through external engagements with global regulators and industry groups
- Leverage all intelligence to enable BeiGene to use Quality as a competitive advantage in terms of compliance, best practice and policy input
- Act as the BeiGene ambassador to shape the external GxP environment by active participation and leadership in appropriate external organizations and conferences
- Establish an internal network of experts at BeiGene who represent the company externally and act as sources of additional intelligence and influence
- In collaboration with BeiGene's Corporate Affairs, Regulatory and other functions, coordinate feedback to draft GxP regulations that are published for consultation
- Internal GxP intelligence expert with significant input to internal GxP policy, Culture of Quality and educational/training programs to continually raise the level of GxP capabilities at BeiGene
- Other duties as assigned
Supervisory Responsibilities:
- This position requires strong cross-cultural and international experience and will operate in an individual contributor role relying on networking and influencing skills in a cross-functional matrixed role, often remotely
Qualification Required:
Other Qualifications:
Minimum of 10 yrs experience in GxP biotech or pharma environment or regulatory agency with multi-national experience a significant advantage
Well networked with external GxP industry organizations (e.g. PDA, ISPE, ICH), ideally with one or more of the following:
Experience in leading external organization project teams
Leading in industry and regulatory authority consortiums/ work groups
Recognized as am organizer, key speaker, moderator or trainer at international conferences / forums on current Quality topics
Experience of leading/ working in a national regulatory authority will be an advantage
Expertise in current topics and trends under discussion within the regulatory environment for Tech Ops and/or R&D
Experience with external platforms for GxP intelligence and surveillance, e.g. Cortellis or Tarius is beneficial
Ability to interpret, synthesize, and communicate information
Excellent English communication skills both written and oral, and presentation skills
Knowledge in a second language preferred
Proven ability to understand technical, scientific and medical information
Some international overseas experience away from home country is desirable
Cultural dexterity in work environments and ability to work effectively across multiple countries, particularly the China, APAC and New Market areas
Must have the ability to work in a team matrix environment and independently interact with various levels of management
Ability to effectively collaborate in a high-paced dynamic environment
Education Required:
Bachelor Degree or higher in a Science or Engineering field
Travel:
- Up to 25% globally
What we offer to our valued employees:
- Market competitive compensation package including performance-based annual bonus scheme
- Company shares (generous welcome grant and performance-based annual equity plan!)
- In-house and external learning and development opportunities
- Fantastic benefits program and keep improving!
Plus you get to work with a dynamic team of collaborative, supportive, diverse, and fun professionals whose mission is clear: Cancer has no borders and neither do we.
BeiGene is proud to be an Equal Opportunity Employer:
We are proud to be an equal opportunity employer and we value diversity. BeiGene 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.
BeiGene Global Competencies
When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, 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
BeiGene is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations.
Due to BeiGene's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeiGene. For further details, please refer to BeiGene's Job Applicant Privacy Policy (https://www.beigene.com/privacy-policy).
If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeiGene's Job Applicant Privacy Policy as well as the relevant privacy terms.
If you have any concern, please DO NOT provide any resume or other personal information to us.
