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Medical Affairs Associate

TekWissen LLC

Job Location:

Santa Monica, CA - USA

Monthly Salary: Not provided by the employer

Posted: 23 June 2026 (30+ days ago)

Application Deadline: 20 September 2026

Vacancies: 1 Vacancy

The job posting is outdated and position may be filled

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV hepatitis B hepatitis C and influenza including Harvoni and Sovaldi.

Position: Medical Affairs Associate

Location: Santa Monica CA / El Segundo CA

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Hybrid

Job Description:

This role supports Medical Affairs activities related to expanded access programs out-of-specification case support and single-patient IND processes.
The individual contributes to the operational execution of treatment-use and clinical support activities by coordinating study- and program-related deliverables managing vendors and external partners supporting site and investigator communications tracking key milestones and risks and helping ensure activities are conducted in alignment with applicable regulations internal procedures and program requirements.

Key Responsibilities:

May assist in the review of study-related and essential start-up documents as delegated by the study manager including clinical protocols informed consent forms investigator brochures pharmacy manuals monitoring plans case report forms CRF completion guidelines and other relevant study plans and charters.
With guidance plays a direct role in clinical study and program execution by managing assigned components of studies or expanded access activities and serving as a member of the study team.
Supports activities associated with out-of-specification programs expanded access programs and single-patient IND requests including coordination of timelines documentation communications and cross-functional follow-up.
Manages vendors and works with multiple contract research organizations and external partners to communicate detailed timelines oversee transferred obligations and ensure performance expectations are met; provides corrective instruction as needed when expectations are not met.
Attends internal team meetings and other required meetings to support program planning issue resolution and execution.
Provides training as needed at investigator meetings and other trial- or program-specific meetings such as site initiation visits and monthly teleconferences.
Creates and reviews site feasibility assessments required for participation where applicable.
Manages and tracks key deliverables such as screening enrollment data flow protocol deviations and other program milestones.
Proactively identifies potential study or program issues and risks recommends and implements solutions and escalates issues appropriately to senior management.
Prepares metrics and status updates on key deliverables for management review.
Assists in the resolution of clinical trial queries for interim analyses primary analyses and final database locks as applicable.
Prepares site newsletters and other correspondence related to clinical trial or program conduct including best practices lessons learned and frequently asked questions in collaboration with the study team.
Assists in the resolution of routine questions from clinical trial sites and external stakeholders in adherence to ICH GCP study protocols and applicable treatment-use requirements.
May participate in special projects and other duties as assigned.
Applies standard medical and scientific terminology appropriately in support of documentation communication and operational execution.

Basic Qualifications:

BS/BA/RN in nursing science or a health-related field with 3-5 years of related experience.

Preferred Qualifications:

Oncology/hematology experience preferred; cellular therapy experience is a plus.
Experience with iMedidata/RAVE EDC is a plus.
Study start-up experience from a prior site-based regulatory role CRO role or sponsor role is a plus.
Ability to manage competing time demands incomplete information and unexpected events.
Strong analytical and problem-solving skills.
High attention to detail.
Outstanding organizational skills with the ability to multitask and prioritize effectively.
Excellent interpersonal verbal and written communication skills in a collaborative work environment.
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities.
Working knowledge of transplant patient care and apheresis collection is a plus.