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Medical Reviewer III

Katalyst CRO

Illinois

On-site

Full time

14 days ago

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Job summary

A leading company in business consulting is seeking a Medical Reviewer III. This role involves providing medical expertise in the review of promotional materials, ensuring accuracy and adherence to medical guidelines. The ideal candidate will have an advanced health science education and relevant experience in clinical and regulatory contexts.

Qualifications

  • 2-5 years experience in clinical practice, academic research, pharmaceuticals, or regulatory environment.
  • Previous regulatory or medical reviewer experience preferred.

Responsibilities

  • Review promotional materials for accuracy and compliance.
  • Provide medical expertise and guidance on brand concepts.
  • Maintain ongoing communication with Medical Affairs and Regulatory peers.

Skills

Strong communication skills
Analytical skills
Organizational skills

Education

Advanced health science education (PhD, PharmD, or MD preferred)

Job description

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Job Description

The Senior Manager/Associate Director, Medical Communications Ad Promo, represents the Medical function in the Material Review Process to guarantee medical, clinical, and scientific data accuracy, relevance, objectivity, balance and alignment with product label. Functions as the lead medical reviewer and sign-off for all promotional materials in designated area(s) of responsibility. Provides proactive guidance as needed for brand concepts and campaigns. Engages Commercial business partners early in the development of promotional materials to enhance efficiency and maintains ongoing communication. Attends, advises, and approves in collaboration /steering committee meetings as the lead Medical Reviewer for promotional review.

Job Description

The Senior Manager/Associate Director, Medical Communications Ad Promo, represents the Medical function in the Material Review Process to guarantee medical, clinical, and scientific data accuracy, relevance, objectivity, balance and alignment with product label. Functions as the lead medical reviewer and sign-off for all promotional materials in designated area(s) of responsibility. Provides proactive guidance as needed for brand concepts and campaigns. Engages Commercial business partners early in the development of promotional materials to enhance efficiency and maintains ongoing communication. Attends, advises, and approves in collaboration /steering committee meetings as the lead Medical Reviewer for promotional review.

Responsibilities

Provides medical expertise and expert review including discussing and collaborating with appropriate review colleagues from other functions.

Reviews promotional materials within the area of scientific expertise to ensure that the materials represent a balanced view of all available product information, all claims are scientifically accurate, the most current and appropriate evidence has been used, and the item is in line with the licensed indications and product safety.

Advises and gives guidance on the rigor of data in relation to scientific standards for promotional claims.

Serves as a medical/scientific expert to advise commercial colleagues and provide proactive guidance on brand concepts/campaigns and proper product/disease state claims development, etc. in collaboration with other business partners.

Maintains current and comprehensive knowledge of aesthetics medical information, techniques, appropriate medical approaches, competitive landscape, and patient outcomes.

Provides strategic input, negotiates/resolves most decisions with business partners and collaborates effectively across functions.

Supports departmental and business strategies. Has accountability for the sound representation of the medical position within and external to client and demonstrates adherence to medical guidance and standards.

Attends, advises, and approves in review meetings as the lead Medical Reviewer for designated product areas.

Maintains on-going communication with therapeutic area peers in Medical Affairs and Regulatory peers to ensure alignment.

Requirements

Advanced health science education or equivalent combination of education and experience required. (PhD, PharmD, or MD preferred).

2-5 years experience in clinical practice, academic research, pharmaceuticals, regulatory/scientific, or medical science liaison (MSL) environment.

Previous experience as Regulatory or Medical reviewer for promotional materials (ideally greater than 1 year).

Medical Affairs Or Medical Communications Experience Preferred.

Strong knowledge of the IFPMA code (and any other applicable code depending on the region).

Ability to learn and convey medical information effectively.

Works individually (reviewing materials electronically) and collaboratively with other review team members.

Strong communication skills, both oral and written, with proven ability to effectively present to audiences of varying levels.

Proven ability to manage multiple projects and product responsibilities.

Strong analytical and organizational skills.

Seniority level
  • Seniority level
    Mid-Senior level
Employment type
  • Employment type
    Full-time
Job function
  • Job function
    Administrative
  • Industries
    Business Consulting and Services

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