Description

Who we are:

At Dendreon, we're transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE® (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer, utilizing a patient's own immune cells to fight the disease.

If you're driven by the opportunity to make a meaningful impact on cancer patients' lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a strong Research & Development group in Seattle, WA, and a highly skilled Commercial team across the nation, Dendreon is at the forefront of cancer treatment innovation.

Core Values:

• Put Patients First: Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity: We commit to transparency, honesty, and always doing what's right.
• Build Trust: Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results: We are accountable to each other and deliver success together.

Job Summary: The Medical Information Specialist within Medical Affairs is responsible for responding to unsolicited inquiries related to Dendreon products, including PROVENGE®, by providing accurate, evidence-based medical information to healthcare professionals, patients, consumers, and payors. Reporting to the Director of Pharmacovigilance, the role supports medical response development, cross-functional collaboration, and pharmacovigilance activities to ensure the safe and effective use of PROVENGE®.

NOTE: This is an onsite position at our Seal Beach, CA location.

• Serves as an essential link between Dendreon Medical Affairs and healthcare professionals (HCPs) and non-HCPs (including patients and payors); assisting with the appropriate dissemination of scientific information, while continuously monitoring enquiry trends and metrics and proactively identifying unmet content needs and product trends to the wider Dendreon audience.
• Works collaboratively with cross-functional teams (i.e. Apheresis Operations, R&MS/Process Engineering, Microbiology, Quality, Pharmacovigilance, Patient Operations and Nursing Services) on all lot failure notifications, reviews and follow-up communications with HCPs.  Key activities include, but are not limited to:
  • Initiation of medical lot failure notification call to practices
  • Peer to peer conversations on type of product failure
  • Post-lot failure follow-up communications with the purpose of  increasing success with subsequent individual patient infusions
  • Processing HCP orders for infusion parameters outside of label guidelines, monitoring manufacturing failures for sterility issues
  • Following-up on sterility failures per product PI, managing and attending weekly rounds meetings
  • Supporting apheresis and technical operations with any medical-related inquires around the apheresis and lot failure notification process.
• Creates and utilizes standard medical content letters (MCLs), and custom response letters (CRLs) to provide scientifically - balanced responses, communications, and resources to external healthcare professionals (HCPs) and non-HCPs (including patients and payors) requesting medical/product information via formal processes such as Medical Information email requests, DOC- based call center, Dendreon-owned websites, or conference/congress-type forums.
• Recognizes and obtains pertinent patient level data on, and accurately transmits, adverse events or product complaints to appropriate internal pharmacovigilance (PV) department within required timelines (within 24 hours of awareness); maintains a record of all external Medical Information interactions via the IRMS database.
• The role will collect, monitor, respond and analyze MIRF activities, including key information topics and questions, and identifies trends via metrics, and recommend opportunities for improvement via ongoing communication to VP of R&MS or Director of PV based on findings.
• Serves as an FDA inspection subject matter expert (SME) for Medical Information and point-person for Medical Affairs, and always ensures audit readiness for Medical Information.
• Facilitates Medical Information services and support for Dendreon Medical Affairs at scientific conferences and meetings including, but not limited:
  • Pre-conference preparation
  • Scientific conference information topics
  • Attend scientific conferences
  • Answer questions at medical booths (in person or virtually).
• Ensures compliance to Medical Information standard work practices and operating procedures; assessing workflows and procedures while partnering with Quality Assurance and Regulatory team members on relevant updates.
• Creates and adhere to Medical Affairs and corporate policies and quality standards.
• Adheres to PV work practices and operating procedures; performing tasks to meet regulatory timelines.
• Collect, analyze and incorporate adverse event information into case report narrative to create a chronological story of the adverse events experienced by the patient.
• Complies with all Dendreon standard work practices and standard operating procedures.

• Advanced clinical and scientific training required (Master's, PharmD, PhD, RN, MD).
• 1-3 years of work experience within the pharmaceutical industry or related health care business field.
• Scientific/clinical experience in the therapeutic area [oncology/prostate cancer/immunology] highly desirable.
• Demonstrated ability to work in a small team and matrixed environment.
• Ability to work collaboratively and coordinate the efforts of in-house and field team members to resolve customer enquiries and produce high-quality responses.
• Demonstrated ability to produce clear, concise, and effective written and oral communications describing scientific and clinical data.
• Well-organized with ability to prioritize tasks, work simultaneously on multiple projects and produce high-quality work documents according to prescribed timelines.
• Able to work under limited direction.
• Proactively and independently approaches work with good problem-solving skills and ability to critically evaluate and synthesis data from a broad range of disciplines.
• Demonstrated ability to pay attention to details, good project management and critical-thinking skills.
• Ability to work in a fast-paced, cohesive, collaborative work environment.
• Ability to gain cooperation of others.
• Proficient in MS Office applications.

Preferred Requirements:

• Previous work experience in Medical Information or Medical Communications a plus.
• Previous work experience in Pharmacovigilance a plus.
• Knowledge of applicable regulatory and legal requirements for the provision of medical information and PV reporting requirements in the pharmaceutical environment a plus.
• Previous IRMS software management experience a plus.
• Experience with medical content writing and/or presenting of scientific, health economic, and clinical data.
• Effective project planning, and an aptitude in presenting scientific and clinical data.

Working Conditions and Physical Requirements:

• This role operates in a standard office setting using standard office equipment.
• Role requires frequent use of video conferencing, standard office software, and digital collaboration tools.
• Must have the ability to lift 10 20 lbs.
• Must have the ability to work in an office environment around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.
• On a limited basis, position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities.
• May encounter prolonged periods of sitting and telecommunications.
• Limited overnight travel for company meetings, and/or scientific congress support may be required.

PI284763163