Associate Manager - Medical Affairs, California

Pay Range : $ 58/hr to $ 64.28/hr

Job Description:

By joining Client, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.

The client is 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 Client-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 Client proposals through the RC review process for:

Coordinate proposal review meetings with RC Team Leads and RC Chairs

Support creation and management of requests for proposals (RFPs)

Support external investigators, MA scientific leads, Medical Scientists, and other stakeholders in developing and submitting rigorous research proposals to Client

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 GCPs 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