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Senior Manager, Submissions Operations Management

Company: BeiGene
Location: Topeka
Posted on: November 22, 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.The Senior Manager, Submission Operations Management will be responsible for supporting the regional head of Submission Operations Management (SOM) by managing the day to day operations of the SOM team. This person will take an active part in continuing to grow the SOM team at BeiGene by recruiting and developing high quality talent and leading the development of robust submission processes based on industry best practices. In this role, this person will serve as the Regulatory Operations representative on Global Submission filings teams providing input and guidance related to submission processes, timelines and training. A key to success in this role is the ability to develop and maintain cross functional relationships such that this collaboration drives high quality work and timely delivery of filings to global health authorities.**Essential Functions of the job:**+ Oversee end-to-end dossier execution activities including submission planning (including scheduling and resource allocation), document format review, submission publishing (including QC), submission dispatch and archiving regulatory submissions in both paper and electronic media to global health authorities (e.g. US, EU, CN and APAC).+ Manage internal Submission Operations Management personnel, vendors and consultants.+ Lead the development and implementation of standards for publishing, archiving, metrics and submission process to global health authorities.+ Monitor and assess business trends, pending regulations or guidance documents and emerging technologies for potential regulatory operations impact, develop action plans, and business tools accordingly.+ Ability to determine and assign adequate resources to projects as needed to ensure high quality outputs.+ Collaborate cross functionally within and outside of RA to provide submission operation subject matter expertise.+ Ability to lead and train others on BeiGene tools and processes.**Qualifications:**+ Bachelors degree preferred or equivalent work experience+ 7+ years experience within a Regulatory Publishing environment including hands on eCTD experience and broad industry standard systems knowledge+ Able to effectively operate both independently and as part of a cross functional team+ Ability to multitask and work under pressure and tight deadlines+ Working knowledge of regulatory guidelines+ Manage complex submission publishing activities associated with generating hard copy and electronic submissions+ Responsible for forward planning of Publishing resources and oversight of junior colleagues. Understands long-term filing plans and advises Regulatory Operations management of resource implications+ Able to present to large groups and executive level meetings as required for communication and transparency. Interface with Regulatory project managers, Regulatory Affairs, and submission subject matter experts (SMEs) to provide support and guidance on submission preparation+ Able to eloquently describe complex issues and recommend a resolution or workaround to management with appropriate consideration of possible impacts**Supervisory Responsibilities:**+ Line management function as required but not limited to performance reviews, compensation reviews, 1:1s, interviewing and onboarding+ Training and mentoring of junior staff+ Manage vendor relationships as required, support issue resolution**Computer Skills** **:**+ Robust regulatory publishing software experience+ Electronic Document management experience+ Working knowledge of business software, including MS Word, Excel, PowerPoint, Project, Adobe Acrobat (and associated plug-ins), Visio and Outlook**Other Qualifications:**Ability to work beyond core business hours as required.**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.BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, Americas, and Europe. 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. For more information, see www.beigene.com.All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.**At BeiGene,** **_how_** **we work is just as important as the work** **_we do_** **. Below are our Values that determine the decisions we make and how we do things.****Patients First****Bold Ingenuity****Collaborative Spirit****Driving Excellence**

Keywords: BeiGene, Topeka , Senior Manager, Submissions Operations Management, Executive , Topeka, Kansas

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