Medical Editor (AMA)

The Planet Group; Mettawa (IL); Hybrid; USD 56,000 - 65,000; Full time

Job summary

The Planet Group is seeking a Medical Editor to join a well-known global pharmaceutical client. This hybrid role in Mettawa, IL offers the opportunity to manage editorial reviews, regulatory submissions, and workflows across promotional and non-promotional materials.

Ideal candidates have a bachelor’s in a technical or science field and prior medical editing experience, with strong attention to detail and proactive work habits in a fast-paced environment.

Qualifications

• Bachelor's degree in technical or science related discipline or related work experience.
• Preferred: 3 years in regulatory, quality or related area.
• Highly detail oriented, with strong communication skills and ability to work independently.
• Experienced medical editing and fact checking of medical materials.
• Proactive about seeking out work when downtime occurs and able to pivot quickly in a fast-paced environment.

Responsibilities

• Manage review and approval process for promotional, non-promotional, and internal use materials.
• Manage electronic approval system, user access, user training and workflows.
• Support FDA Ad Promo Submissions.
• Support QC and regulatory reviews of materials.
• Coordinate review and approval processes for materials.
• Maintain knowledge of approval routing grids per SOP and route materials for approvals.
• Attend PRC meetings to answer editorial questions.
• Collaborate with marketing operations on prioritization for routine approvals and major campaigns.
• Complete editorial review of materials, final reviews, reapprovals, and other review types as needed.
• Archive OPDP correspondence per guidance from Reg Ad promo lead.
• Contribute to development and update of departmental work instructions.
• Prepare materials, form 2253, cover letter and send to Reg Operations for publishing and OPDP submission.
• Support other departmental initiatives (e.g., process improvements).

Skills

Attention to detail

Communication skills

Independent worker

Education

Bachelor's degree in technical or science related discipline

Job description

The Planet Groupis seeking a MedicalEditortojoin one of our well-known global pharmaceutical clients.

• Pay: $41-46.90/hr depending on experience
• Location: Hybrid in Mettawa, IL (T-TR onsite)
• Duration: 2 years

MedicalEditorResponsibilities:

• Managereview and approval process for promotional, non-promotional and internal use materials
• Manage electronic approval system, user access, user training and workflows
• SupportFDA Ad Promo Submissions
• SupportQC and regulatory reviews of the materials
• Coordinate promotional and non-promotional materials review and approval processes
• Maintain in-depth knowledge of approval process routing grids per SOP and route the materials for approvals accordingly
• Attend the PRC meeting discussions to answer any editorial questions/concerns
• Collaborate with marketing operations on prioritization for routine approvals as well as during major campaign launches and label updates
• Complete editorial review of promotional and non-promotional materials, final reviews, reapprovals and other review types as necessary
• Archive OPDP correspondence per guidance from Reg Ad promo lead
• Contribute to development and update of departmental work instructions
• Prepare materials, form 2253, cover letter and send them over to Reg Operations for publishing and OPDP submission
• Support other departmental initiatives as needed (e.g. process improvements)

MedicalEditorQualifications:

• Bachelors degree in technical or science related discipline or related work experience
• Preferred: 3 years in regulatory, quality or related area
• Highly detail oriented, and great communication skills, able to work independently as needed
• Experienced medical editing
• Fact checking of medical materials
• Proactive about seeking out work when presented with downtime
• Ability to pivot or shift gears quickly, working in a high volume, fast-paced environment

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