Description

Summary

• Participates in site and/or regional PD Disclosures departmental meetings
• Operates within a global organization with flexibility for early meetings (1-2 times per week)
• Represents Disclosures and supports effective and efficient cross-functional PDR coordination, appropriate resources, and timely, thorough and compliant execution
• As assigned, may act as a standing or ad hoc member of other teams for special or ongoing initiatives and projects

• Continues to expand his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics
• Obtains and applies in-depth knowledge of Roche and regulatory guidelines, procedures and best practices
• As needed, provides Disclosures expertise to cross-functional teams and other groups
• Contributes to development and maintenance of policies and/or Standard Operating Procedures (SOPs) on clinical trial registry and clinical trial results database processes
• Identifies studies required for registry and results postings, including applicable trials for results postings on relevant external websites. Ensures that responsible PDR management and staff are aware of timelines, deadlines and other requirements
• Tracks missing/late registry entries and Clinical Study Reports (CSRs) and liaises with PDR teams regarding dates of new product or line extension approvals
• Liaises with project teams and affiliates to ensure they understand their responsibilities in relation to regulatory documentation disclosures
• Submits protocol documents for preparation of registry entry and for quality control checks, i.e., consistency between registry and protocol, cross-protocol and franchise consistency. Similarly submits CSR document for preparation of results entries
• Works with cross-functional team members to obtain data, reviews and approvals required for completion of registry and results entries on internal and external websites
• Monitors workflows for registry and results entries to ensure timely and on-target completion
• Completes document and data uploads in applicable systems
• Ensures protocol information is included in the registry as soon as the study design is finalized and first ethical/regulatory approval is received
• Ensures that study results are uploaded into results databases within applicable timeframes
• Tracks correspondence with cross-functional teams and departments via departmental mailboxes and ensures appropriate responses are provided in a timely manner

• Participates in and/or otherwise supports development and implementation of new or updated PDR and/or Disclosures-specific systems, processes or other relevant tools
• Completes routine and ad hoc analysis and reporting. Responsible to keep all internal customers, partners and stakeholders abreast of progress and interim updates. Does so by following prescribed departmental procedures, practices and protocols and by using standardized reporting and communications tools/templates and other resources
• Participates in other special projects, as and when assigned, or otherwise requested
• Participates in routine and ad hoc departmental meetings and other business reviews or meetings to remain, at all times, fully abreast and apprised of evolving internal and external needs and requirements. Expected to share best practices within the department and cross-functionally, identify and communicate opportunities for departmental enhancements and efficiencies
• Consistently complies with all governing laws, regulations, Roche SOPs and other guidelines

Requirements:

Requirements

• Bachelors Degree preferred (life sciences disciplines strongly preferred)
• Average of 3 or more years

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