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Senior Specialist, Medical Affairs

Organon
Organon
3+ years
Not Disclosed
10 Nov. 24, 2024
Job Description
Job Type: Full Time Remote Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

The job description is for a Medical Services, Senior Specialist at Organon. The role focuses on responding to medical inquiries, managing promotional material reviews, and ensuring compliance with medical and scientific standards. Here’s a detailed breakdown of the role:

Position Overview:

The Sr. Specialist will primarily manage the triage and response to inquiries from healthcare providers and external stakeholders, overseeing medical information processes and promotional review compliance.

Key Responsibilities:

Medical Information:

  • Inquiry Response: Address unsolicited on-label and off-label inquiries from healthcare providers and stakeholders.
  • Professional Communication: Ensure responses are high-quality, scientifically accurate, and professionally communicated.
  • Standardization: Develop standardized answers for frequently asked questions in collaboration with Medical Advisors and MSLs.
  • Research & Clinical Support: Research and compile information from literature to provide clinical support in a balanced and accurate format.
  • Adverse Event Reporting: Report any adverse events or product quality complaints to the relevant departments.

DPOC (Designated Point of Contact) Process Management:

  • Product Inquiry Management: Ensure proper classification and routing of product inquiries to meet regulatory and business requirements.
  • DPOC Database Maintenance: Maintain the DPOC database and ensure it is accurately updated.
  • Key Performance Metrics: Generate and report DPOC metrics monthly.
  • Gap Identification: Identify process gaps and provide solutions to improve the medical information process.
  • Training & Support: Train Medical Advisors and MSLs in managing DPOC and medical information requests.

Medical Review:

  • Promotional Material Review: Oversee the review and approval process for promotional materials, ensuring compliance with regulations and internal policies.
  • Regulatory Knowledge: Stay informed about regulations and laws governing promotional materials.
  • Compliance Leadership: Provide guidance and training on compliance to country staff.

Required Experience and Skills:

  • Experience: At least 3 years of pharmaceutical experience, preferably in medical information, contact centers, or medical review. Experience in women’s health products is preferred.
  • Scientific Integrity: High level of scientific and ethical integrity, with a strong sense of responsibility for response deadlines.
  • Communication Skills: Excellent written and verbal communication skills, along with strong collaboration abilities.
  • Regulatory Knowledge: Understanding of domestic regulations and industry codes.
  • System Knowledge: Familiarity with core systems, tools, and metrics related to medical literature.
  • Language: Business-level proficiency in English.

Organon Overview:

  • Organon is a $6.5 billion global healthcare company focused on improving the lives of women and their families through a diverse portfolio of health solutions, particularly in women’s health, biosimilars, and other therapeutic areas.
  • The company is committed to diversity and inclusion and is an equal opportunity employer.

Additional Information:

  • Employee Status: Project Temps (Fixed Term)
  • Relocation: No relocation assistance
  • VISA Sponsorship: Not available
  • Travel Requirements: Must meet applicable travel and credentialing requirements, including vaccinations.
  • Flexible Work Arrangements: Likely available depending on business needs.

This position offers an experienced individual the chance to manage medical information processes and ensure the high standards of medical communications, with a focus on women’s health.