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.
The Associate, Submissions Operations Management supports the Regulatory Affairs team in the coordination, preparation, and submission of all INDs/NDAs/MAAs and life cycle management of these submissions in both paper and electronic format to global health authorities. Some experience with submitting to at least one of the following regions EU, US, Canada and Asia Pacific countries in eCTD, NeES and or paper format.
Essential Functions of the job:
- Assist with the report level publishing and submission level compilation for global major applications and lifecycle submissions (routine). This includes document management tasks, creation and qc of all navigation and technical acceptance (e.g. hyperlinking, bookmarking, validation) to ensure submission compliance for Health Authority (HA) acceptance
- Support Regulatory Affairs to deliver high quality and consistent maintenance health authority submissions, through the provision of strategic insight and broad operational level knowledge for those submission types
- Perform document management tasks including file transfer, storage, tracking, and archival of Regulatory submission documentation
- Support the Regulatory Operations team on both submission (e.g. Global Filing team) and Regulatory projects teams to provide status and input related to key deliverables (e.g. impact to submission timelines)
- Review and contribute to the implementation of standards, templates, and procedures related to regulatory documents, recommend associated process improvements
- Assist in the evaluation, implementation, and or upgrade of software, e.g., publishing, validation, viewer or electronic document management systems
- Working knowledge of submission requirements and guidelines for all submission types, both paper and electronic and experience in the regulatory submission process
- Familiarity with formatting of regulatory submission documents ensuring that documentation meets external and internal company submission-ready standards
- Attention to detail, organized and ability to support multiple simultaneous projects
- Ability to work under challenging deadlines with high quality and consistency.
- Ability to work flexible business hours as required to support global submissions within a global Regulatory Operations team. Ability to work beyond core business hours as required.
Qualifications:
- BA/BS Degree in life science or computer science preferred
- 1+ years in the biotechnology or pharmaceutical industry
- Regulatory operations experience within a regulated environment with experience and knowledge in formatting and publishing of applications, amendments and supplements (manufacturing, nonclinical, clinical)
- Experience with CTD/eCTD structure and format
- Knowledge of EU or US health authority and ICH regulations and guidance as it pertains to format and submission structure
- Familiar with regulatory requirements for APAC preferred, Canada and other regions desirable
Computer Skills:
- Experience using eCTD compliant publishing system
- Proficiency with MS-Office Suite and Adobe Acrobat, including pdf plug-ins that support submission readiness
- Knowledge of MS Word Templates, their function and use
- Working knowledge of Adobe Acrobat PDF Bookmarks and Hyperlinks
- Experience with document management and Regulatory Information Management Systems (RIM)
Other Qualifications:
N/A
Travel:
Travel as required (Approximately 10%)
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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