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Healthcare Information Consultant
2 months ago
Position Title: Medical Information Specialist - GU/Immunology
Location: Remote with potential preference for NYC/NJ
Department: Medical Affairs
Reporting Structure: Reports to Medical Information Manager/Director
Overview:
The Medical Information Specialist is a vital member of the Medical Affairs team, tasked with delivering expert medical and scientific insights pertaining to Genitourinary (GU) and Immunology therapeutic domains. This role encompasses addressing inquiries from healthcare professionals, aiding in product launches, crafting educational resources, and ensuring that all communications are scientifically sound and adhere to regulatory standards.
Key Responsibilities:
- Medical Information Support:
- Address inquiries from healthcare professionals (HCPs), patients, and internal stakeholders concerning products in the GU and Immunology fields.
- Provide scientifically accurate and current information regarding product usage, safety, efficacy, and related topics.
- Maintain a comprehensive understanding of clinical and scientific literature relevant to GU and Immunology products.
- Content Development:
- Create and revise standard response letters, frequently asked questions (FAQs), and other medical information documents.
- Collaborate with cross-functional teams (e.g., Regulatory Affairs, Medical Affairs, Marketing) to produce educational and training materials.
- Ensure all content complies with internal and external regulations, including promotional review requirements.
- Product Launch Support:
- Engage in the planning and execution of medical information activities related to product launches.
- Deliver medical information training to sales and other internal teams to ensure accurate and effective communication with HCPs.
- Contribute to the creation of product dossiers and other launch-related materials.
- Compliance and Regulatory:
- Ensure all medical information activities are conducted in accordance with relevant regulations, including FDA, EMA, and other global regulatory bodies.
- Monitor and interpret regulatory guidelines to ensure the company's medical information practices remain current and compliant.
- Assist in the preparation of regulatory submissions and audits as necessary.
- Collaboration and Communication:
- Work closely with Medical Science Liaisons (MSLs), Clinical Development, and other teams to align on messaging and share pertinent information.
- Participate in medical conferences and meetings to stay updated on the latest scientific advancements in GU and Immunology.
- Act as a resource for internal teams regarding medical information inquiries and resources.
- Data Analysis and Reporting:
- Analyze inquiry trends and generate reports to provide insights into product usage, safety, and other relevant topics.
- Identify unmet needs in the medical community and relay feedback to R&D and commercial teams.
- Assist in the development of real-world evidence and other data-driven initiatives to support product positioning and strategy.
Qualifications:
- Education:
- Advanced degree in a scientific discipline (PharmD, PhD, MD, or equivalent) with a focus on Immunology, Oncology, or related fields.
- Experience:
- Minimum of 2-5 years of experience in Medical Affairs, Medical Information, or related roles within the pharmaceutical or biotech industry.
- In-depth knowledge of GU and/or Immunology therapeutic areas, with a strong understanding of clinical research and regulatory requirements.
- Skills:
- Exceptional written and verbal communication skills, with the ability to convey complex scientific information clearly and concisely.
- Strong analytical skills with the ability to interpret and summarize clinical data.
- Proficiency in medical information databases, literature search tools, and regulatory submission platforms.
- Ability to work collaboratively in a fast-paced, cross-functional environment.
- High attention to detail and strong organizational skills.
Preferred Qualifications:
- Experience with product launches and lifecycle management in the GU or Immunology space.
- Prior experience interacting with healthcare professionals and providing medical information support.
- Familiarity with global regulatory guidelines and promotional review processes.
Work Environment:
This position may require occasional travel to attend conferences, meetings, or training sessions. The role is office-based with the possibility of remote work, depending on company policy.
