consulting management part time

Job Details

Consultant, Promotional Review/Medical PRC Reviewer, Pharmaceuticals

  • *Part-time: will be anywhere from 80-100 hours a month

Summary

The Medical Information Manager is responsible to manage medical information and communication for assigned products that will be marketed by the company by providing oversight for the prompt, accurate, and scientifically and medically balanced responses to unsolicited medically related inquiries from internal and external customers. The responsible individual will collaborate with other Medical Affairs colleagues and work closely with key members of internal departments including Legal, Regulatory Affairs, Marketing, Clinical Operations, Market Access, Sales and Sales Training to provide medical support for development, implementation, maintenance, and enhancement of ongoing medically-related activities related to company product(s). All policies, Standard Operating Procedures, Work Instructions and related documents should be followed or created... accordingly.

Duties / Expectations of Role

  • Develop and maintain a library of standard medical response documents (ie, standard response letters, frequently asked questions [FAQs]) for use in response to medical and product -related inquiries from healthcare professionals and consumers
  • Monitor medical information activities and develop reports to ensure compliance with all legal, regulatory and internal guidelines and best practices
  • Conduct medical/scientific review of all materials and concepts used in promotion of company branded products and sales training materials. This review is done in collaboration with Legal and Regulatory members (MLR, Medical Legal Review) to ensure that all promotional material (sales detail aid, slide decks, websites, patient materials, etc.) meet the US Food and Drug Administration (FDA) Code of Regulations and guidance documents, as well as high ethical standards
  • Respond verbally to inquiries from healthcare professionals and consumers as necessary
  • Review cases received and identify training needs related to knowledge about company product related programs and disease state information
  • Assist with medical review of materials used in external communications (press releases, announcements, etc.)
  • Assist with development, review and/or maintenance of product and disease-related materials in collaboration with other Medical Affairs employees
  • Provide medical support for Marketing and Sales Training departments (e.g. development of promotional and/or sales training materials for advisory boards, consultant, and speaker training meetings) including working directly with their respective vendors
  • Provide medical information support at medical/scientific conferences as needed

Mandatory Requirements

  • Advanced degree (PhD, MD, PharmD)
  • At least three years of experience in medical information or related area involving writing, communication and scientific skills
  • Understand and interpret clinical data
  • Able to provide input on appropriate interpretation of references used in promotional materials
  • General understanding of statistical analyses utilized in clinical trials
  • Ability to problem-solve unstructured or ambiguous challenges
  • Strong command of English, both written and verbal
  • Attention to detail and documentation
  • Strong working knowledge of the FDA Code of Federal Regulations and guidance documents
  • Self-starter who thrives in a collaborative, yet less structured team environment
  • Proficient working knowledge of MS Office Suite, particularly PowerPoint, Word, and Excel

Preferred Requirements:

  • Experience with Veeva vault
  • Neuroscience experience
  • experience with labeling and managed care organizations

Additional Notes

  • Will be remote to start; Princeton Office when offices are eligible to re-open (Depending on Leadership); this is flexible
  • Must be comfortable in a global environment

Term & Start

  • 12-month contract
  • Start ASAP
  • Part-time: will be anywhere from 80-100 hours a month

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