Work cross-functionally both within finance and across the company and with other stakeholders, including the external auditors, to ensure financial reporting-related deliverables are completed in a timely manner.
Manage the monthly close process and ensure proper reconciliation of all general ledger accounts and integrity of the financial statements; support of the SEC Filings, earning press releases, audit committee and other financial presentations.
Analyze analytical data, identify trends, and provide recommendations; review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings.
Provide CMC regulatory guidance, both internally and externally (CMOs), regarding CMC changes such as analytical changes, specification changes and manufacturing changes plus their impact on regulatory filings.