Medical Information Manager

Medical Information Manager at ATR International Medical Information Manager at ATR International in Morris Plains, New Jersey Posted in 2 days ago.

Type:

full-time

Job Description:

ATR International is hiring an Associate Manager, Medical Information for a major client! 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 Gilead.

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 upport 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 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 Qualifications BA/BS with 3+ years' relevant experience. Relevant experience in quality, compliance, governance and risk management in the biopharmaceutical or related industry amiliarity with post-marketing medical affairs operations and activities General understanding of the PhRMA code regulations, standards, and business requirements Effective communication and interpersonal skills, to include developing relationships across organizational levels

Location:

Hybrid in

Parsippany, NJ Hourly Rate:

$60.00 - $75.00 Benefits Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance. Paid sick leave is provided in accordance with applicable state and local laws. Compensation Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select. Work Authorization ATR International, Inc. cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar). Candidates must have valid U.S. work authorization. ATR International, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.