Senior Publications Manager

Job Title: Senior Manager, Medical & Affiliates, R&D Quality

Location: Parsippany, NJ 07054 (Hybrid)

Duration: 7 Months

Overview
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 that are managed by R&D Quality Process, Documentation and Learning to advance a culture of quality and compliance across the client.

Primary Responsibilities

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 Client's 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 elevate 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

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

Client's Core Values

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)

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