Senior Manager, Medical & Affiliates, R&D Quality
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Job Location:
Parsippany, NJ - USA
Monthly Salary:
Not Disclosed
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.
Position: Senior Manager Medical & Affiliates R&D Quality
Location: Parsippany NJ 07054 (Hybrid)
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Location: Parsippany NJ 07054 (Hybrid)
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Hybrid
Job Description
- Client is seeking a Sr. Manager/Associate Director of Medical & Affiliates Research & Development (R&D) Quality to play a pivotal role in reinforcing and sustaining a strong culture of quality compliance governance and risk management for our cross-therapeutic area medical affairs activities.
- The Sr. Manager/Associate Director will support Medical & Affiliates R&D Quality operations by promoting document management monitoring initiatives independent projects and learning solutions that are managed by R&D Quality Process Documentation and Learning to advance a culture of quality and compliance across Client
Primary Responsibilities
- Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates quality operations including:
- Synthesizing Quality issues arising from deviations inspections and audits; supporting the development and maintenance of Medical Affairs (MA) process documentation
- Creating analytic tools to enhance data insights and leadership communications
- Supporting initiatives and projects led by Quality Business Partners in collaboration with the business
- Developing sophisticated presentations to support project execution and decision making
The role requires the ability to remain flexible and effectively manage multiple priorities simultaneously. Pharmaceutical industry experience is preferred.
Audits Inspections & Self-Assessments
- Support team needs in their conduct audits inspections and self-assessment activities in coordination with functional business partners
- Support internal audit and regulatory inspection deliverables including readiness preparation inspection execution and response activities as needed
- Assist with the resolution of relevant audit and inspection findings and the implementation of corrective actions
Medical Governance Monitoring & Reporting
- Support the development of reporting capabilities including an understanding of what metrics R& D Quality possesses or can develop that reflect the needs of Medical Governance & Affiliates operations
- Proactively identify trends influencing Clients overall compliance and propose monitoring and auditing tactics to further assess and evaluate trends
- Support monitoring and routine/ad hoc analysis and reporting
- Assist in providing day-to-day guidance support and problem solving to internal stakeholders regarding monitoring and training issues
- Oversee monitoring tracking reporting and communications to ensure compliance with required training
Cross-functional Partner
- Support strategic partnerships with our cross functional stakeholders including Medical Affairs Global Medical Strategy and Operations Affiliates Legal Ethics &Compliance and R&D Quality
- Work collaboratively with other functional groups and relevant stakeholders e.g. Regulatory Affairs and Patient Safety to advance the Medical Governance and Affiliate role as a Quality Business Partner
- Support the gathering of information necessary to escalate an issue of critical importance or controversy to the appropriate levels
Medical Governance and Affiliates Compliance Culture
- Develop trusted relationships with Medical Affairs associates and Affiliate partners at all levels to promote an accountable complaint culture
- Assure completeness and currency of documentation that describe policy and process practices across Medical Affairs activities and Affiliates
- Promote a culture of quality compliance and patient centricity
Qualifications
- BA/BS with 3 years relevant experience.
- Relevant experience in quality compliance governance and risk management in the biopharmaceutical or related industry
- Demonstrated critical thinking skills
- Familiarity with post-marketing medical affairs operations and activities
- General understanding of the PhRMA code regulations standards and business requirements
- Effective communication and interpersonal skills
- Excellent organizational and project management skills
- Demonstrated critical thinking skills and ability to define and implement quality and compliance constructs standards metrics and practices that drive quality and compliance across cross-functional operations and activities
- Effective communication and interpersonal skills to include developing relationships across organizational levels
- Excellent organizational and project management skills
- Previous people-management experience and a track record of effective leadership whether through direct line or matrix team management
TekWissen Group is an equal opportunity employer supporting workforce diversity.
