This position will have responsibility for the quality assurance oversight of manufacturing operations at company's CMO including the review of batch records and product release.
Support the Commercial Leadership team in annual Business Planning Process, including proactively working on risks and opportunities related to revenue and investments.
Review/revise Data Management related study plans including Data Management Plan, Data Validation Plan and other study documents to ensure quality and standardization.
Contribute to the strategic IT Launch roadmap to build Commercial capabilities in CRM, Case Management for Patient Services, Sales Roster, Incentive Compensation, Reporting and Master Data Management.
Provide leadership and management within the department through a structural process of objective setting, performance appraisal and individual development as appropriate.
Work closely with medical and clinical leadership and other cross functional partners and outside vendors in order to effectively execute key commercial activities.
The Medical Science Liaison develops and maintains professional relationships with external healthcare practitioners to provide comprehensive medical and scientific support for company assigned therapeutic areas.
Working with the Executive Director, Corporate Compliance, Policies and Training, on designing auditing and monitoring programs to ensure robust implementation of corporate compliance policies and training.
Participates in meetings to identify data collection instruments and database design requirements to ensure that the data evaluated are free of bias, contain maximum information, and satisfy analysis requirements.
Interacts with internal partners, CMOs and contract laboratories during the technology transfers of analytical methods, clinical batch testing, stability testing and CMC compilation of assigned projects.
Annual Report 