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Senior Manager, Commercial Artwork Development

Company: BeiGene
Location: Bismarck
Posted on: September 20, 2022

Job Description:

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.General Description:The Senior Manager, Commercial Artwork Development is responsible for overseeing development, approval, and control of commercial labeling for final product presentations for all BeiGene Commercial Product by: Collaboration with contract artwork vendors, contract manufacturing partners, commercial label printers, and key BeiGene stakeholders/cross-functional project teams to gather the appropriate market specific information for label development. Delivering flawless artwork design and coordination per agreed timelines. Contributing to labeling development efficiencies through the utilization of standard processes and platforms to enhance commercialization and lifecycle management for BeiGene products globally. Development and maintenance of labeling artwork metrics to triage artwork requests, monitor trends, and ensure artwork deliverables to commitments for HA submissions, commercial product launches, and labeling artwork lifecycle updates. Accountable for market specific artwork layout of product package insert, carton and container labeling, including printer proof approvals when applicable. Support end to end commercial artwork process improvements including artwork creation, version control, proofreading, cross functional stakeholder review and approvals, production implementation, and commercial artwork repository.Essential Functions of the job:

  • Facilitate initiation, progression, and closure of commercial artwork designated change controls, associated impact assessments, change actions, and other commercial artwork specific QMS document records.
  • Standardization: Aligning with key stakeholders for increased efficiency in commercial artwork process and document through Global Standards and local SOPs.
  • Identify complexities/process gaps and proactively define effective solutions.
  • Identify innovative technology solutions for artwork creation and control and keep up to date on industry trends.
  • Maintain right first time, lead time and other metrics as appropriate to measure performance.
  • Identify and ensure area of responsibility complies with appropriate change control and the most current quality systems and company policies.
  • Work with designated consultants, contract manufacturers, and external business partners to ensure compliance with business standards and requirements.Competencies: Demonstrates experience and a strong understanding of commercial artwork development, approval, and control process. Understands comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, FDA, EMA, NMPA) Experience in change control, deviation investigation and CAPA implementation Strong analytical, problem solving, and communication skills Strong collaboration and excellent team skills to be successful in cross-functional and multi-cultural teams Experience with drug supply requirements in accordance with Drug Supply Chain Security Act (DSCSA) Serialization and Track & Trace Experience with Single Unit Coding (SUC) requirements in accordance with globally adopted GS1 standardsEducation Required:Bachelor or Masters Degree in Graphic Design, Package Engineering, Supply Chain, Life Sciences or similar education required.7+ years progressive experience in Artwork development and control preferably within the biotech, medical device, or pharmaceutical industry.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.Computer Skills: Computer Skills: Proficient in Microsoft Office applications (Word, Excel, and Outlook) Systems.Other Qualifications: Fluency in English Required. Due to global nature of company early morning or evening meetings may be required.Travel: 20%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.

Keywords: BeiGene, Bismarck , Senior Manager, Commercial Artwork Development, Executive , Bismarck, North Dakota

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