Role Description
The IB Temporary - Medical Information Specialist will be accountable for aligning, implementing, and integrating systems, tools, technologies, and processes for Medical Information and Medical Communications from an operations perspective, as it relates to inquiries from a global contact center processing Medical Affairs Information requests for ANKTIVA (nogapendekin alfa inbakicept-pmln) with Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG unresponsive nonmuscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors, global Investigator site inquiries, and patient/caregiver inquiries about eligibility into our Clinical Trial programs. The role will ensure professional standing and integrity with patients, caregivers, and healthcare professionals through high-quality and aligned medical information and communication.
Essential Functions
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Responds and/or resolves escalated inquiries from unsolicited consumers, health care professionals and other external customer requests for medical and safety information received via telephone, website/e-mail, and/or letter in the ImmunityBio call center.
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Composes and updates standard response documents (SRDs), seeks Medical | Legal | Regulatory approval for new SRDs; researches and writes custom responses; and supports the development of medical information standard operating procedures (SOPs).
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Provides labeled and unlabeled efficacy, safety, and related scientific information responses in accordance with regulatory requirements, industry standards and client.
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Identifies, documents and reports adverse events, special situation events and product complaints in an accurate, clear, and concise manner to Pharmacovigilance.
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Reviews and confirms eligibility for current clinical trial programs, and if applicable, connects patient/caregiver with appropriate clinical trial contact.
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Creates compelling and impactful medical materials for patients, healthcare providers (HCPs), and population health decision makers, including field medical decks, evidence submissions, and medical response documents.
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Participates in Promotional Review Committee and Medical Review Committee as a medical reviewer and supports clinical operations across ImmunityBio’s oncology portfolio.
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Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data.
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Documents, triages, and fulfills all medical information enquiries in an accurate, comprehensive, and timely fashion.
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Troubleshoots issues with the medical information database vendor, as needed.
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Generates medical information metrics and reports, as required by leadership.
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Adheres to company privacy policies, ensuring any confidential information or personal data and Data Privacy regulations.
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Comply with the Company’s health and safety policies.
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Performs other activities as assigned.
Qualifications
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An advanced scientific degree (PharmD, MD, or PhD) required.
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2+ years of industry experience in a pharmaceutical Medical Affairs setting required.
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2+ years of Medical Information and Medical Communication Operations experience required.
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Experience with Veeva Vault Promomats is strongly preferred.
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Experience with medical information databases is strongly preferred.
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Professional experience in call center operations, Medical Information Inquiry tracking, Standard Response Letter writing, and medical operations policies required.
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Prior experience in Oncology (Prostate, Bladder Cancer, Lung Cancer, Glioblastoma, Colo-Rectal Cancer) is a plus.
Knowledge, Skills, & Abilities
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Ability to handle confidential and sensitive information with discretion and show good judgement, compassion, honesty, integrity, and trust building behaviors in all dealings is essential and required.
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Knowledge of HIPPA and other federal guidelines.
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Excellent verbal and written communication skills, as the position will interface with key opinion leaders, patients, caregivers and senior leadership team members within ImmunityBio.
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An ability to effectively communicate, collaborate and deliver an excellent work product in a fast-paced, and rapidly changing and dynamic environment.
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Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards.
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Excellent customer-service orientation to talk with patients and caregivers interested in clinical trials managed by ImmunityBio.
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Self-motivated, with initiative and the ability to take ownership of and follow through on tasks.
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Ability to multi-task and shift priorities quickly while working under tight deadlines.
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Proficient in Microsoft Office computer applications.
Working Environment / Physical Environment
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This position will work remotely.
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Regular work schedule is Monday – Friday, within standard business hours.
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Flexibility is available with manager approval.
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Possible travel up to 1 day a month.
Compensation
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National Market (all markets unless identified as Premium): $6,154.00 (entry-level qualifications) to $6,769.00 (highly experienced) bi-weekly.
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Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston): $7,115.00 (entry-level qualifications) to $7,827.00 (highly experienced) bi-weekly.
Benefits
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Medical, Dental and Vision Plan Options.
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Health and Financial Wellness Programs.
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Employer Assistance Program (EAP).
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Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability.
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Healthcare and Dependent Care Flexible Spending Accounts.
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401(k) Retirement Plan with Company Match.
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529 Education Savings Program.
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Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks.
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Paid Time Off (PTO) includes: 11 Holidays.
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Exempt Employees are eligible for Unlimited PTO.
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Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day.