Manager - Medical Affairs

About Nexinfo:

NexInfo is a consulting firm focused on improving business processes and automation in the Supply Chain and Product Lifecycle Management sectors. They offer services in business process design, software implementations, managed services, staff augmentation, and SaaS solutions. The company aims to help businesses across industries achieve their goals through industry best practices, lean process design, and advanced software solutions. Their ERP-related services address challenges such as inventory management, product lifecycle management, demand management, forecasting, sales and operations planning, business intelligence, security compliance, and financial alignment.

Job Title: Associate Manager - Medical Affairs

Location: Foster City CA (Onsite)

Type: Contract

Description

Job Title: Manager, Global Medical Affairs Research
Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products)

We are seeking a Manager within Phase 4 Research in LIVE (liver, inflammation, emerging viruses, and established products) to join our Global Medical Affairs Research team. This role is responsible for coordinating proposal reviews and supporting portfolio management of investigator-sponsored research (ISR), collaborative research, and MA-led sponsored research across LIVE. The ideal candidate will have previous experience in Phase 4 research or clinical operations, and knowledge of the therapeutic area.

Specific Job Responsibilities:
Assist in managing meetings for our LIVE Research Committee (RC)
Manage reviews of ISRs, COs and MA-led GS proposals through the RC review process for:
o Coordinate proposal review meetings with RC Team Leads and RC Chairs
o Support creation and management of requests for proposals (RFPs)
o Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Gilead
Support the management of the LIVE portfolio including liaising with key cross-functional partners such as Clinical Operations, local affiliates and external investigators
Review abstracts and/or manuscripts that result from the phase 4 program
Contribute to ensuring that the research processes and study execution align with MA research policy and governance, integrated evidence plan priorities, and overall program strategy
Work with the team to track, monitor and intervene with external investigators to ensure timely execution of contracted studies, and support closure of studies when not meeting contracted milestones
Act as a resource for Research Committee Chairs, voting members, standing members, proposal champions, affiliates, and reviewers
Contribute to process improvements related to research proposal and study management systems
Manage projects to completion, anticipating obstacles and difficulties that may arise, resolving them in a collaborative manner and engage in project management activities as needed by assigned RC Team Lead and/or Senior Manager

Educational and other Requirements:
Professional degree (eg, PhD, PharmD); OR master s degree (eg, MS, MPH) with 2+ years of experience in clinical or observational research including research operations; OR Bachelor s degree with 6-plus years of experience
Must be cognizant of and adhere to regulatory and legal (Business Conduct) requirements for clinical trials and other Medical Affairs activities; knowledge of FDA regulations, ICH guidelines and Google Cloud Platforms governing the conduct of clinical trials
Demonstrated project management and organization skills including process improvement, management of multiple resources and priority projects with tight timelines while maintaining attention to detail
Ability to work in a global environment which may require participation in meetings outside of standard work hours to accommodate time zone differences
Affinity for a collaborative, team-oriented environment, and approach; must be able to appropriately interact within MA and across Development, senior management, and external customers/vendors
Excellent interpersonal, written, and verbal communication skills
Proven track record of executing clearly defined goals and objectives in a fast-paced environment
Self-motivated to work independently and having a positive attitude while working as part of teams
Ability to engage and manage multiple stakeholders to achieve the objective

Preferred Qualifications:
Understanding/experience in in MA/pharmaceutical industry in phase4/externally sponsored research programs or Clinical Development
Scientific knowledge/experience in LIVE TAs

Thanks & Regards,

Joseph Thambi
Senior Executive - Talent Acquisition