What are the responsibilities and job description for the Medical and Regulatory Affairs - Sr. Manager Medical Information position at Omni Inclusive?
1. Manage daily operations of MI vendors, including but not limited providing oversight on escalations, standard response document maintenance and variant process in conjunction with Associate Director
2. Navigate matrix partnerships to ensure operational excellence and strategic decision making
3. Ensure accurate, balanced, and current resources are available and communicated, to execute on stakeholder needs, content deliverables compliantly and with a high level of quality
4. Work with business solutions partners to optimize use of system and technology
5. Identify continuous improvement opportunities in alignment with the Customer Engagement Center strategic objectives
6. Engage, participate, and drive initiatives of the External Engagement and Enablement organization.
Expected Areas of Competence :
1. Ability to work independently and take initiative to resolve issues
2. Ability to establish effective, strong, and productive relationships and working interfaces with relevant stakeholders and leverages both formal and informal networks and relationships to obtain information and achieve results
3. Have current awareness related to TA and ability to critically evaluate scientific data
4. Understanding of WW and US specific regulations, guidelines, and the practice of medicine as it pertains to MI
5. Ability to critically analyze performance against quality measures, metrics, and process. Able to develop and implement appropriate actions in response to outcomes
6. Strong organizational skills, with the ability to problem solve and develop solutions
Essential Requirements
PharmD
Experience in the pharmaceutical or related industry including MI and ability to demonstrate knowledge of MI function
Broad understanding of diseases and pharmacotherapy; specific disease state and pharmacotherapy knowledge in Immuno-Oncology, CV, or Immunoscience
Working knowledge of Medical Information and content creation including ability to evaluate information from multiple sources
