Overview

Who we are.

Dendreon is making the battle against cancer personal. Our flagship product PROVENGE® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.

If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beal, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.

Core Values:

• Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
• Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
• Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
• Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
• Drive Results. Be accountable and execute – we win together when everyone performs.

Your Role:

The Sr. Medical Information Specialist is a customer-focused group within Medical Affairs that is responsible for responding to unsolicited inquiries regarding Dendreon products.

The Senior Medical Information Specialist is primarily responsible for developing and providing direct medical, scientific and operational input into core medical information documents and product lot failure notifications for both healthcare professionals (HCPs) and non-HCPs.

The position will be responsible for processing and documenting inquiries received by phone or email with fair and unbiased medical information through published scientific literature and confidential company data.

The position will have broad supporting responsibility for the generation of standard and customized medical information response letters to fulfill unsolicited Medical Information requests related to Dendreon and its product - PROVENGE®.

The Senior Medical Information Specialist also works closely with both medical and non-medical cross-functional teams in the provision of medical writing, authoring supporting documents, clinical education, communication, market access, and support to both internal (within the Medical and greater Dendreon organization) and to external stakeholders to ensure safe and effective use of PROVENGE®. The position also requires a strong understanding of pharmacovigilance and adverse event reporting.

Responsibilities

Your Work:

• Serves as an essential link between Dendreon Medical Affairs and healthcare professionals (HCPs) and non-HCPs: 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.
• Assists with mentoring our Medical Information Specialists, create and execute Medical Information related trainings. Assesses existing processes to streamline for efficiency.
• Works collaboratively with cross-functional teams (i.e. Apheresis Operations, R&MS/Process Engineering, Microbiology, Dendreon Connect, Pharmacovigilance and Nursing Services) on all lot failure notifications, reviews and follow-up communications with HCPs.
• Creates and utilizes standard response letters (SRLs), and custom response letters (CRLs) to provide scientifically - balanced responses, communications, and resources to external healthcare professionals (HCPs) and patient response letters (PRLs) to non-HCPs requesting medical/product information.
• Accurately transmits adverse events or product complaints to appropriate internal department within required timelines.
  • Conducts follow up on adverse events as needed.
  • 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 Medical Affairs or Chief Medical Officer 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 to pre-conference preparation, scientific conference information topics, and attending scientific conferences and answering questions at medical booths (in person or virtually) and collecting competitive intelligence.
• Ensures compliance to Medical Information standard work practices and operating procedures.
• Assessing workflows and procedures while partnering with Quaility Assurance and Regulartory team members on relevant updates.
• Creates and adhere to Medical Affairs and corporate policies and quality standards.
• Complies with all Dendreon standard work practices and standard operating procedures.

Qualifications

Education Requirements:

•  (Master’s, PharmD, PhD, BSN or MSN). 

Job Requirements:

• A minimum of 3 years of work experience within the pharmaceutical industry within the Medical Information arena.
• 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 (e.g. Metrics, flow charts, interpretation of data, pivot tables, and medical writing).
• Experience with medical content writing and/or presenting of scientific, health economic, and clinical data.
• Knowledge of applicable regulatory and legal requirements for the provision of medical information in the pharmaceutical environment required.
• Well-organized with the ability to prioritize tasks, manage multiple projects and produce 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.
• Possess the ability to thrive in a fast-paced work environment.
• Ability to gain cooperation of others.
• Proficient in MS Office applications.
• Experience in pharmacovigilance desired.
• Previous IRMS software management experience a plus.

Working Conditions and Physical Requirements:

• Onsite at Seattle, WA office
• On a limited basis, position requires flexible working hours, including some nights and weekends, as needed for support of customer and business activities (e.g. conference attendance).
• May encounter prolonged periods of sitting and telecommunications.
• Limited overnight travel for company meetings, and/or scientific congress support will be required.
• Ability to sit or stand for extended periods of time 
• Intermittent walking to gain access to work areas
• Finger dexterity sufficient to use a computer and to complete paperwork activities
• Vision sufficient to use a computer, to read written materials and to complete paperwork activities;
• Hearing sufficient to communicate with individuals by telephone and in person
• Ability to lift up to 25 pounds.
• Job performed in an office environment
• Must have the ability to work around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.