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BeiGene Director/Associate Director, Global Safety Submissions Head in Boston, Massachusetts

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.

Company Overview:

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160) is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 7,700 employees across China, the United States (Cambridge, MA; Ridgefield Park, NJ; Emeryville, CA & San Mateo, CA), Switzerland and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients

General Description:

Responsible for establishment of strategy & Processes to ensure oversight of individual case safety reports & aggregate safety report submissions to regulatory authorities, investigators, ethics committees, business partners and other destinations for BeiGene’s marketed and investigational products

Essential Functions of the Job:

  • Define regulatory reporting strategy as well as established and ensure standard operating procedures are in place cross-functionally to support the global submissions process as well as to ensure the global safety database is able to support these processes through collaboration with the BeiGene Safety Systems team

  • Oversee processes for generating, submitting, tracking and verifying expedited and required individual case safety report (ICSR) and aggregate safety report submission to regulatory authorities, Affiliates, and business partners, investigators, ethics committees for clinical trials and marketed products in order to ensure regulatory compliance and safety data exchange agreement requirements

  • Ensure that expedited reports and aggregate safety reports (e.g.: DSUR, 6 monthly line-listings, PADER, PBRER) will be reported within the timelines required by regulatory authorities

  • Oversee metrics/KPIs and collaborate with ICSR Case Management, Aggregate Safety Report, Medical Review, PV Training, Compliance & Quality teams to implement corrective & preventive actions (CAPAs) as necessary

  • Will be responsible for recruitment, direct management, oversight and development of BeiGene Global Safety Submissions staff across all regions

  • Provide oversight to Contract Research Organizations (CROs) involved in safety reporting to local regulatory authorities, business partners, investigators, ethics committees, and other destinations, as appropriate

  • Act as Global Safety Submissions Business lead in contract negotiations and development of work practice documents, influencing and educating parties on regulatory submission requirements and processes

  • Responsible for inputs into the Global Safety Submissions budget

  • Other key responsibilities include provide inspection support, maintaining awareness of evolving global regulatory reporting requirements, managing BeiGene Global Safety Submissions related requests and work with PV Training & Compliance team on regulatory requests and quality and compliance adherence

  • May lead and participate as Submissions subject matter expert (SME) on cross functional projects as needed

Other Key Activities:

Conventions Maintenance

•Contribute to the establishment & updates of conventions/templates

Quality Assurance

•Contribute to identifying action items and plan to correct quality issues within ICSR and ASR submissions process

•Facilitate communication of quality performance findings

Performance Metrics

•Support the definition and execution of volume, quality, compliance and productivity metrics

Continuous Improvement

•Participate in meetings to discuss continuous improvement opportunities

•Review already analyzed issues, prioritize, plan improvements

•Responsible for continuous improvements in the global submissions processes

•Contribute to root cause analysis of process issues & corrective actions

Product Launch Plan

•Contribute to launch plan development & implementation with respect to ICSR & ASR submissions requirements

Preparation for Regulatory Inspection

•Act as SME for Submissions in audits and inspections representing submissions business processes and standards

•Support the evaluation of current processes and assess alignment with regulatory expectations, guidelines, mandates

Internal Global Patient Safety Department Development

•Create Policies, guidelines, SOPs

•Participate in product meetings

•Hire, orientate, manage, mentor, and develop staff

Minimum Requirements – Education and Experience:

Director/Associate Director Education:

Bachelor’s degree in life sciences, pharmacy, nursing or equivalent health experience or Advanced Life Sciences Degree, or MBA

Director Experience:

  • Bachelor’s Degree with 10+ years of pharmaceutical industry experience in a global safety/pharmacovigilance setting

OR

  • Masters’ Degree or above with 7+ years of pharmaceutical industry experience in a global safety/pharmacovigilance setting

  • 5 + years of management experience preferred

  • 5+ years of global submission experience preferred

Associate Director Experience:

  • Bachelor’s Degree with 8+ years of pharmaceutical industry experience in a global safety/pharmacovigilance setting

OR

  • Masters’ Degree or above with 6+ years of pharmaceutical industry experience in a global safety/pharmacovigilance setting

  • 5 + years of management experience preferred

  • 5+ years of global submission experience preferred

Other Qualifications:

  • Excellent communication skills (verbal and writing); Clear and confident presentation skills; ability to network and partner within global organizations; results oriented and strong attention to detail

  • Demonstrated leadership experience & abilities

  • Expert knowledge of safety reporting regulations for clinical development & post-marketed products

  • Ability to identify, analysis and resolve complex reporting issues to move projects forward and identify key compliance issues broadly

  • Demonstrated relationship building and cross-functional teamwork skills Proficiency in technical safety system platforms, including Argus

Supervisory Responsibilities:

Recruitment, management, training and oversight of BeiGene Global Safety Submissions team including, Senior Manager Safety Submissions, Manager Safety Submissions, Safety Submission Senior Associates and Safety Submission Associates

Computer Skills:

Argus safety database and other safety database platforms and tools as required, MS Office suite including Word, Excel, Powerpoint, Visio

Travel:

No regular travel or business trips anticipated; ad hoc business trips as needed

Computer Skills: Intermediate knowledge working with a safety database for retrieval of safety information; Advanced knowledge of MedDRA; MS Office Suite: Advanced application capability with Excel, PowerPoint, and Word. Familiarity with data mining tools and exploratory analyses tools such as Spotfire

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.

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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