Job Title: Sr. Manager, Medical Review
PART TIME - Average 20 hours per week
Location: Remote
Contract: 1 year with possible extension
What hours and days will this person be working:
Flexible as long as all review activities are done on time; the team this person would support is split between US and Europe so some availability in early mornings (if based in US) for meetings is required. Meetings are usually on a Wednesday at 8am Chicago time. Expect on average about 20 to 30 job bags per month (2 per day)
What are the top 5 skills/requirements this person is required have?
1. Represent Medical in the
Material Review Process (to guarantee medical, clinical, and scientific data accuracy, relevance, and objectivity).
2. Provide proactive guidance as needed for brand concepts and campaigns. Collaborate with commercial business partners early in the development of
promotional materials to enhance efficiency.
1. Serve as medical / scientific expert to advise commercial colleagues on proper product and disease state
claims development.2. Engage with
Medical Affairs Directors to ensure
promotional materials are aligned with
medical strategy and tactics.3. Maintain a comprehensive knowledge of disease pathophysiology, diagnostic techniques, appropriate therapeutic approaches, competitive landscape, and patient outcomes.
- Minimum of 1 year of experience in a medical review role
- Knowledge/expertise of Gastroenterology and/or Immunology therapeutic area
- Remotely, both individually (reviewing) and in a group setting (providing feedback and attending review meetings to review upcoming and current promotional content).
- Role works cross-functionally with multiple internal stakeholders/partners (i.e. regulatory review, legal, ethics, Medical affairs, commercial).
- Previous experience within Medical Affairs or medical information
JOB SUMMARY:• Electronically review promotional and other materials and provide medical expertise and review as described above. Includes discussing and collaborating with appropriate review colleagues from other functions.
• Attend, advise, and approve in review meetings as the lead Medical Reviewer for the designated therapeutic area.
• Responsible for providing proactive guidance as needed for brand concepts and campaigns.
• Support review of non-promotional materials, and development and review of other related medical affairs materials as required.
• Support medical affairs tactics as required
KEY DUTIES AND RESPONSIBILITIES:• For designated therapeutic area of responsibility, attends, advises, and approves in review meetings as the lead Medical Reviewer for promotional review.
• Functions as lead Medical Reviewer and sign-off for all promotional materials.
• Leads and contributes to medical promotional review
• Provides proactive guidance as needed for brand concepts and campaigns. Engages Commercial business partners early in the development of promotional materials to enhance efficiency.
• Supports non-promotional review, and other medical affairs initiatives and tactics as required and if appropriate.
• Review of commercial promotional and non-promotional content as well as medical content
MINIMUM REQUIREMENTSEducation and Experience
• Advanced health science education or equivalent combination of education and experience required. (PhD, PharmD, or MD preferred)
•
1-5 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 and non-promotional materials preferred (ideally greater than 1 year).
• Immunology/Gastroenterology experience preferred
•
Medical affairs or medical communications experience preferredEssential Skills and Abilities• Ability to learn and convey
medical information effectively.• Works individually (reviewing materials electronically)
• Works collaboratively with other review team members
No CV Required
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