Associate Manager Medical Information - I

Medical Reviewer And Medical Information Consultant

This role consists of both Medical Reviewer for Promotional Review and Medical Information. As a Medical Reviewer, the team member will be an integral part of the Promotional Review Committee and the Medical Review Committee. The team member will be responsible for ensuring the medical and scientific accuracy of submitted materials as well as verifying that statements are adequately supported by appropriate evidence and the cited data.

As a Medical Information Consultant, the team member will be an integral part of the US and Global Medical Information (MI) team who demonstrates therapeutic and product knowledge of Kite Cell Therapy products to optimize internal and external customer communications. This will be a remote-based position but must be able to attend weekly meetings that are generally set within Pacific Standard Time business hours.

Job Responsibilities:

Serving as a medical reviewer for the US and global materials submitted to the medical and promotional review committees.

Ensure medical and scientific accuracy of the US and global materials.

Ensure all claims and statements are supported by adequate scientific references and are cited appropriately.

Perform all medical reviews in a timely and expedient manner by the requested due date.

Attend and participate in all regularly scheduled and ad hoc review committee meetings.

Support and collaborate with cross-functional partners (Regulatory, Legal, Commercial, Scientific Communications, Patient Services, Market Access, etc.) to achieve mutual understanding and consensus.

Maintain an advanced level of medical knowledge including but not limited to the disease area of focus, product mechanism of action, therapeutic area clinical and real-world data, and the competitive landscape.

Researching and preparing responses for MI inquires, as well as interfacing with and supporting MI escalations from the US and Global Medical Information vendor/call center:

• Serves as the subject matter expert for MI on Cell Therapy product(s) and associated therapeutic area(s).
• Create and deliver timely responses to unsolicited medical information inquiries/requests.
• Assist with creating/developing Standard Response Documents (SRDs) for the product portfolio, as needed.

Knowledge/Skills:

Excellent written, verbal, and interpersonal communication skills

2 years + of experience in medical writing, medical information/drug information, and/or relevant clinical experience

Working knowledge of the Veeva platform (preferred)

Ability to work well in multi-disciplinary teams

Ability to manage multiple projects in a fast-paced environment

Must have strong attention to detail, excellent project management, and problem-solving skills, and think creatively

Required Qualifications:

Advanced scientific or medical degree (MD, Ph.D., PharmD, or equivalent).

Promotional review experience in the Pharmaceutical or Biotech Industry.

Prior corporate experience in hematology/oncology, immune-oncology, or related therapeutic area is highly preferred.