Medical Information Manager

Initial Therapeutics, Inc.; Boca Raton (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

401K plan with employer match

Medical, Vision, Life and Dental

Pet Insurance

Company Paid Holidays

3 Weeks’ Paid Time Off

Tuition Assistance

Shuttle to Tri-Rail

Easily accessible to Tri-Rail

Job summary

ADMA Biologics in Boca Raton, FL seeks a Medical Information Manager to provide medical, scientific, and technical expertise supporting product communications and essential medical support for its products.

The role requires up to 50% domestic travel, PharmD/RPh/RN/PhD or equivalent, and 2–4 years pharma industry experience in drug information or Medical Affairs. Strong writing, organizational, and regulatory knowledge are essential.

Qualifications

• Experience providing medical information and scientific support.
• Strong writing and communication skills for cross-functional teams.
• Knowledge of FDA regulations and medical affairs compliance.

Responsibilities

• Create, review, and summarize medical information content for ADMA products.
• Develop and maintain Medical Affairs materials and letters.
• Collaborate on training materials for Medical Affairs and liaise with internal stakeholders.
• Support field Medical Science Liaisons with scientific information for HCP interactions.
• Translate customer insights into new scientific materials with Medical Affairs leadership.
• Respond to Medical Inquiries through multiple channels with accurate information.

Skills

Medical Information

Writing

Regulatory Compliance

Education

PharmD / RPh / RN / PhD or similar

Job description

Job Description

ADMA Biologics is a biopharmaceutical company relentlessly committed to creating superior products for immunodeficient patients at risk for infection. It is our devotion to this underserved population that fuels us and our hands-on approach to production and development that sets us apart. If you are looking for a dynamic, innovative, growing company in the biopharmaceutical industry that is committed to excellence and integrity, then consider ADMA Biologics. We currently have an exciting opportunity available for a Medical Information Manager in Boca Raton, Florida!

Job Title:Medical Information Manager

Position Summary:

As a product and disease state expert within Medical Affairs, the Manager, Medical Information, will provide medical, scientific and technical expertise to support product scientific communications planning and to provide essential medical support to ADMA Biologics products.

Essential Functions and Responsibilities:

• Creating, updating and/or reviewing medical information content on ADMA products to ensure complex scientific content is summarized in a concise, simple and balanced manner utilizing the highest level of evidence and critically evaluating the data and literature.
• Develop, review and maintain Medical Affairs materials including customized medical letters, standard response letters, publication library, and summarize any clinical papers in medical affairs library.
• Collaboration on company training materials for Medical Affairs
• Maintain close interactions and liaise with Compliance, Clinical Development, Marketing, Sales and other internal stakeholders, as required.
• Coordinate development, review and approval of clinical Data on File packets to support promotional claims, as required.
• Contribute to the development, review and maintenance of Medical Affairs scientific materials, including Managed Market documents, in collaboration with Medical Affairs colleagues.
• Incorporate customer insight to identify, update, and develop new scientific materials in conjunction with Medical Affairs leadership
• Respond to Medical Inquiries and provide support for field Medical Science Liaisons with appropriate scientific information for their exchanges with Health Care Providers via multiple channels (i.e. verbal, written).
• Supply Medical Affairs field team information to provide to Healthcare Providers regarding the appropriate use and clinical differentiation of ADMA products.
• Identify, analyze and/or report trends in medical and scientific insight (including Medical Inquiries) to Medical Affairs stakeholders.

Up to 50% domestic travel is required for this position.

Education and Experience Requirements:

Education Requirements:Relevant educational background with a PharmD, RPh, RN, PhD or similar.

Experience Requirements:

• Two to four years of experience in pharmaceutical industry in drug information, preferably in Medical Affairs Drug Information Residency or equivalent experience.
• Strong organizational skills, writing and time management.
• Medical information call center experience preferred but not required.
• Immunology, respiratory and Infectious Disease background a plus.

Compliance Requirements:

The minimum compliance expectation for this role entails strict adherence to FDA regulations and company policies governing sales and marketing activities. This includes completion of required compliance training, accurate documentation of sales interactions, and adherence to data privacy regulations. Additionally, the role requires proactive participation in compliance reviews, prompt reporting of any potential issues, and ongoing education to stay updated on relevant FDA regulations.

Job Description Footer:

In addition to competitive compensation, we offer a comprehensivebenefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet InsuranceCompany paid STD and LTD
• Company Paid Holidays
• 3 Weeks’ Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station

ADMA Biologics uses E-Verify to confirm the employment eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.

ADMA Biologicsis an Equal Opportunity Employer.