BeiGene 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.

PLEASE ENSURE YOU APPLY WITH AN ***ENGLISH*** CV

MANDATORY EXPERIENCE: Pharmaceutical Industry, Oncology, Preferred Hematology

No Agencies

General Description:

The Qualified Person Responsible Information and Publicity (QP RIP) and Pharmaceutical affairs Associate Director is responsible for medical information and publicity in Belgium and Luxembourg.

As Pharmaceutical Affairs Associate Director, he (she) also organizes locally the quality, regulatory and compliance activities within the affiliate and in collaboration with EU departments in accordance with Belgian and Luxembourg laws and regulations (Good distribution practices, Good pharmacovigilance practices, Good manufacturing practices) and company requirements.

He (she) also supports the transversal activities carried out by the marketing, medical, compliance, distribution, supply chain, pharmacovigilance, HR and market access Eu and BeLux departments.

He/she takes over the responsibilities to designate a back-up for the QP-RIP role. Prior to any leave or departing, the QP-RIP acquaints the Back-up RIP and the FAMHP of her/his absence by phone or by e-mail and gives the necessary instructions to the relevant people regarding measures to be taken concerning ongoing files.

Essential Functions of the job:

In the performance of his duties, the Employee is responsible for the following tasks in Belgium and Luxembourg :

• Regulatory affairs:
• Verification of the translation compliance of the SPC and the leaflets.
• The RIP must sign the “Declaration of Conformity” for registration of variations on a marketing authorization (Circular 469)
• Evaluation and final approval of abridged product information (abbreviated SPC)
• Relationships with the Health competent authorities
• Proceed with mandatory submissions to local Health authorities and maintain health database up to date (e-compendium, etc.)
• Implementation of change control after regulatory approvals (marketing authorization, variations, risk management plan, etc.)
• Participation to early access programs management
• Marketing monitoring (report to health authority on initial marketing date, prohibition or restriction decisions or any information that can influence the benefit to risk assessment)
• Review of Medical advertising and medical information processes
• Participation to local training process
• Pharmaceutical documentation archiving management
• Participation to Regulatory intelligence
• Risk management approach (document management, complaints, audits, continuous improvement, premises, suppliers, shortages, etc.) and business continuity plan implementation
• Monitoring of local pharmaceutical vendors
• Medical information management :
• Collaboration with the Medical information department (data management, review of standard responses, access to literature database)
• Collection, registration and follow-up of responses to medical information requests
• Reconciliation of shared medical information data
• Monitoring of KPI
• Providing the information i.f.o. MAH (e.g.: questions from patients, professionals,…)
• Medical advertising and information :
• Collaboration with the commercial and medical team in the review and approval of the promotional and non-promotional material
• Submission to Health authority and Institution of promotional material, if applicable
• Logistical management of material with traceability (withdrawal, recall, archiving, etc.)
• Establishing an appropriate internal procedure for approving advertising and various promotional activities
• Ensure local field team is using appropriate material
• Training material :
• Contribution to trainings on pharmaceutical and compliance processes
• Review of training material for commercial and medical teams
• Evaluation of skills
• Overseeing the training of medicinal representatives visiting doctors, pharmacists, and other healthcare professionals.
• Quality assurance / distribution / supply chain:
• Set up/follow-up of audits for local pharmaceutical activities
• Participation to audits and inspections by authorities (FAGG-AFMPS, etc.)
• Follow up of Batch release for distribution and tracking/traceability of batches distributed locally
• Batch recall monitoring with marketing authorization holder, Health authority and distributor
• Shortage monitoring with Health authority
• Quality complaints management
• Standard Operating Procedures (SOPs) creation and implementation
• Quality compliance monitoring
• Deviations monitoring
• KPI monitoring (definition, collection and analysis of KPI for major pharmaceutical activities)
• Drug safety management :
• Implementation of the local pharmacovigilance process
• Designation as local Qualified Persons responsible for Pharmacovigilance
• Interaction with European Qualified Person responsible for Pharmacovigilance (EEAQPPV) and Global Patient Safety team
• Local Procedures and data management
• Report to Competent authorities
• Collection, registration, report and follow-up of adverse events
• Follow-up of local scientific and medical literature for pharmacovigilance relevant information
• Local Signal detection
• Participation to Periodic Safety Update Report (PSUR) and PSMF updates
• Reconciliation of shared PV data
• Implementation of key performance indicators (KPI)
• Participation to Compliance management :
• Monitoring of local law about anti-bribery, transparency and compliance of interaction with HCPs and HCOs
• Participation to legal review of agreements with healthcare professionals, hospitals, organizations, etc.
• Participation to Personal data protection organization
• Submission of HCPs / HCOs sponsorships to local authorities (MDEON)
• Transparency disclosure
• Ensuring compliance with the regulation on “samples”
• Belgian RD 11/01/1993 setting the conditions in which the delivery of medicines for human use in the form of samples can be organized
• Ensuring compliance with the regulations on “premiums or advantages”
• RD 07/04/1995 on the information and publicity concerning human medicines, articles 13§ 4, 15 and Law of 25/03/1964 on Medicines, article 10

In Luxembourg the responsibilities are similar to the ones in BE, in contrast with BE, the above responsibilities could be separated and executed by different persons and/or departments.

Qualifications:

• A minimum of 10 years of pharmaceutical industry/biotech in regulatory affairs in Belgium (and Lux is a plus)
• Fluent in English, French or Dutch (trilangual is a plus)
• Oncology market experience strongly preferred
• Experience in working in a dynamic, lean environment is preferred
• In depth knowledge and understanding of the regulatory system and challenges and opportunities
• Hands-on experience and successful track record in contacts with regulatory authorities
• Demonstrated success and experience supporting product pre-launch, launch and post-launch
• Demonstrate deep scientific knowledge
• Demonstrated ability to translate strategic insights into practical, well-designed processes
• Demonstrated ability to operate in matrix environment
• Demonstrated cross-functional collaboration and out-of-the-box thinking
• Agile, strategic thinking and ability to develop innovative global reimbursement/pricing strategies
• Highly skilled in influencing cross-functional teams, including interfacing with key internal and external stakeholders and with scientific and commercial teams
• Excellent interpersonal, oral and written communication skills, including ability to synthesize data and deliver a clear overview of market access strategy, opportunity and risks

Education Required:

Pharmacist or Doctor’s degree to be eligible for being designated as QP-RIP – as per Belgian law

Computer Skills: Standard Computer Skills required

Travel: Approximately 20% of time

Competencies:

Ethics – Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

Communication – Listens and gets clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

Teamwork – Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone’s efforts to succeed. Contributes to building a positive team spirit. Shares expertise with others.

Adaptability – Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

Technical Skills – Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

Dependability – Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

Project Management – Communicates changes and progress; Completes projects on time and budget.

BeiGene Is an Equal Opportunity Employer

BeiGene is an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristics protected by law. As a federal contractor, BeiGene has established affirmative action programs to ensure non-discrimination and affirmative action in BeiGene’s policies and practices for qualified women, minorities, protected veterans, and individuals with disabilities. The narrative portions of BeiGene’s affirmative action plans for individuals with disabilities and veterans are available for inspection at our offices during normal business hours. Employees and applicants interested in inspecting these plans should contact our Human Resources department by email at [email protected] for assistance.

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

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.

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