Senior Manager, Medical & Affiliates, R&D Quality

LanceSoft, Inc.

Parsippany, NJ

On Site

Contract

$68.33 - $68.33/hr

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About this role Would you like to play Are you excited to use Seeking a Sr

Would you like to play a crucial role in developing life-saving therapies? Are you excited to use your pharma business expertise to partner with internal teams and external partners as we strive to cure unmet medical needs?

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 managed by R&D Quality Process, Documentation, and Learning to advance a culture of quality and compliance.

Responsibilities Partner with Medical & Affiliates Synthesize Quality issues arising from support the development and maintenance

Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates' quality operations
Develop sophisticated presentations to support project execution and decision making
Synthesize Quality issues arising from deviations, inspections, and audits

Support initiatives and projects led by Quality Business Partners in collaboration with the business
support the development and maintenance of Medical Affairs (MA) process documentation
Create analytic tools to enhance data insights and leadership communications

Required Skills & Experience BA/BS with 3 years' relevant Relevant experience in quality, compliance, Demonstrated critical thinking 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
Familiarity with post-marketing medical affairs operations and activities
Effective communication and interpersonal skills
Demonstrated critical thinking skills

Relevant experience in quality, compliance, governance, and risk management in the biopharmaceutical or related industry
General understanding of the PhRMA code regulations, standards, and business requirements
Excellent organizational and project management skills
BA/BS with 3 years' relevant experience

Benefits Integrity (always doing the right Teamwork (collaborating in good faith) Excellence (working at a high

Integrity (always doing the right thing)
Teamwork (collaborating in good faith)
Excellence (working at a high level of commitment and capability)
Accountability (taking personal responsibility)
Inclusion (encouraging diversity)
About R&D Quality and Medical Governance & Affiliates

Environment Are you excited to use Partner with Medical & Affiliates Support initiatives and projects led

Are you excited to use your pharma business expertise to partner with internal teams and external partners as we strive to cure unmet medical needs?

Partner with Medical & Affiliates Quality Business Partner team to support the ecosystem of medical affairs and Affiliates' quality operations

Support initiatives and projects led by Quality Business Partners in collaboration with the business

Previous people-management experience and a track record of effective leadership, whether through direct line or matrix team management

Teamwork (collaborating in good faith)

About R&D Quality and Medical Governance & Affiliates R&D Quality and the Medical Governance & Affiliates team is a phenomenal place to develop your skills and expertise

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