Business Consultant – Regulatory & Medical Review
Location: Wadsworth, OH
Salary Range: $150,000‑$175,000 per year
Responsibilities
- Awareness of regulatory guidelines (PhRMA, IFPMA, USFDA‑OPDP, MHRA, EMA, etc.) for product promotion, advertising standards council guidelines, Sunshine Act, Prescription Drug Marketing Act, anti‑kick‑back laws, plagiarism and copyright laws.
- Perform exhaustive medical and regulatory review of content in German to ensure medical and regulatory accuracy, consistency with references, sequencing, accuracy of bibliography references, and that scientific information in branded or promotional content is current, valid and adheres to the respective country’s pharma regulations.
- Translate content from English to German.
- Focused review of content, detecting and highlighting of branded or promotional content in German.
- Share content review status updates with project lead on a daily and weekly basis.
- Check scientific accuracy and correctness of content along with German local nuances to ensure content is adequately supported by evidence, depicted tables/graphs and artwork accurately represent the data, and there are no contradictory messages in the body of the content.
- Ensure correct citations are used accurately according to company referencing style and conventions.
Qualifications
- Bachelor of Computer Science
- 8–20 years of experience in medical regulatory or related field (exact field not specified)
Benefits Summary
- Discretionary Annual Incentive
- Comprehensive Medical Coverage: Medical & Health, Dental & Vision, Disability Planning & Insurance, Pet Insurance Plans
- Family Support: Maternal & Parental Leaves
- Insurance Options: Auto & Home Insurance, Identity Theft Protection
- Convenience & Professional Growth: Commuter Benefits & Certification & Training Reimbursement
- Time Off: Vacation, Personal Time Off, Sick Leave & Holidays
- Legal & Financial Assistance: Legal Assistance, 401(k) Plan, Performance Bonus, College Fund, Student Loan Refinancing
#J-18808-Ljbffr