We have an exciting opportunity within our Regulatory Operations team for a Senior Manager who will be responsible for Clinical Trial Disclosure and Data Transparency Activities. These activities include coordinating disclosure, transparency and data sharing communication and outreach plans, monitoring the landscape to ensure that BeiGene’s data transparency policy is up to date, and creating key performance indication (KPI) reports that demonstrate adherence to regulations. This person will help to establish the Regulatory Data Disclosure and Transparency function at BeiGene and help to establish an approach for regulatory submissions and management of the disclosure of the information in those submissions.
This position will provide global support to the Regulatory Affairs with an immediate focus work on products for China and the US. This person will collaborate closely with other teams including Regulatory Affairs, Legal, Medical Writing and Clinical Operations to establish Regulatory Data Disclosure department.
Essential Duties and Job Functions
As the lead of Data Disclosure and Transparency you will help to establish the team within BeiGene.
Manages the general and overall coordination of Disclosure, Transparency and Data sharing of information to regulatory authorities and the public of information provided in Regulatory Submissions.
Drives development and implementation of processes, standards, and training material for Disclosures & Transparency activities.
Generation and execution of strategic communication plans and channels for sharing of data.
Provides strategic guidance to regulatory project teams on Data Disclosure Guidance such as Policy 0070. Establish a process for submitting policy 0070 submissions.
Leads strategic processes and provides strategic value to the overall positioning of the department with BeiGene
- Leads and promotes initiatives in moving the company forward with the implementation of new systems, processes and services.
- Participates in group initiatives and authoring of training manuals, checklist documents, business practices, or standard operating procedures (SOPs)
- Provide Assessment of BeiGene’s performance in any external communications/trackers/rankings related to Disclosure, Transparency and Data Sharing, such as the Good Pharma Score Card.
- Maintenance of the Disclosure, Transparency and Data Sharing internal stakeholder map.
- Interacts frequently with other functional areas. Maintains constructive and positive interactions with colleagues.
- Discusses the status of ongoing projects with the team, sets expectations where necessary and reports on project statuses to senior management. Takes decisions regarding issue resolution.
- Able to eloquently describe complex issues and recommend a resolution or workaround to senior management with appropriate consideration of possible impacts.
Task management and performance management of junior employees may be required, to include but not limited to: biannual performance reviews, goal setting, leave approval, sick leave acknowledgement, SOP compliance tracking, regular 1-1 meetings.
Identifies future resourcing needs, requests requisitions with justification, reviews CVs, telephone screens, arranges face-to-face interviews with department administrator, gathers feedback and recommends the successful candidate.
Manage vendor relationships including required resources, issue resolution and contract negotiation.
Knowledge, skills and experience:
- Management experience is preferred.
- Preferably 3 or more years of direct experience in disclosures and/or data transparency, clinical operations or medical writing/clinical submissions.
- Core understanding and familiarity with Clinical Development, Clinical Trial conduct, and the Regulatory Submission process is preferred.
- Working knowledge of business software, including: MS Word, Excel, PowerPoint, Project, Adobe Acrobat and Outlook.
- Experience in the preparation and submission of documents using regulatory/document management systems (e.g. VAULT®, Documentum®, FirstDocs®, Publishing Tools, and Validation tools) is preferred
- Strategic thinking is required, with a focus on process development, improvement and optimization.
- Excellent verbal and written skills and attention to detail are required as well as time management and prioritisation skills.
- Candidates will demonstrate an ability to balance multiple tasks to achieve goals and to meet deadlines and customers’ expectations.
- Experience working in and directing cross-functional teams is highly preferred.
- 10+ years of relevant experience and a BA or BS or 8+years with Master or above
- Resilient profile with the ability to deliver in an ambiguous environment
- Curious with learning agility
- Operationally excellent
- Organized with systematic approach to prioritization
- Process orientated to achieve the business objective
- Ability to learn new technologies quicky