Senior Specialist Medical Affairs

Job Title: Senior Specialist – Medical Affairs

Location: 2901 Harbor Bay Parkway, Alameda, CA 94502

Duration: 6 Months

Work Arrangement: 100% Onsite

Pay Range: $55 - $59 per hour (W2)

We are seeking a “Senior Specialist – Medical Affairs” to join one of our leading healthcare clients.

Position Summary

The Senior Specialist – Medical Affairs will serve as a key contributor to clinical study teams, providing scientific expertise to support trial design, protocol development, and ongoing data analysis. This role involves cross-functional collaboration and supports publication and regulatory activities within the assigned therapeutic area.

Key Responsibilities

• Act as an active member of study teams, providing scientific input for trial design and ongoing analysis during protocol development, including preparation of pre-protocol documentation.
• Support the development of study-related documents such as investigational brochures, protocols, informed consent forms, case report forms, and reports of prior investigations.
• Conduct literature reviews and competitive intelligence analysis to inform trial design and interpret study results within the assigned therapeutic area.
• Review and critically evaluate statistical analysis plans and clinical data sets.
• Facilitate effective communication across cross-functional teams including Sales & Marketing, R&D, Clinical, Regulatory Affairs, Quality, Risk Management, and Project Management.
• Support study-level publication planning, including manuscript development, submission, and coordination with investigator authors.
• Manage the review and revision process for abstracts and manuscripts to ensure timely publication of clinical data.
• Prepare documentation to support regulatory submissions and assist in responding to inquiries from regulatory authorities.
  
  
  

We are looking for the candidate who are eligible to work with any employers without sponsorship .

If you’re interested, please click “Apply” button.