Medical Information Manager
Job Title: Medical Information Manager – Medical Affairs
Epizyme, Inc. is a fully integrated, commercial-stage biopharmaceutical company committed to its mission of rewriting treatment for cancer and other serious diseases through novel epigenetic medicines. In addition to an active research and discovery pipeline, Epizyme has one U.S. FDA approved product, TAZVERIK® (tazemetostat), for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma (ES) who are not eligible for complete resection; adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies; and adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options. These indications are approved under accelerated approval based on overall response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The company is also exploring the treatment potential of tazemetostat in investigational clinical trials in other solid tumors and hematological malignancies, as a monotherapy and combination therapy in both relapsed and front-line disease settings. By focusing on the genetic drivers of disease, Epizyme seeks to match medicines with the patients who need them. For more information, visit www.epizyme.com.
Epizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies. Join a dynamic, diverse and fun work environment consistent with Epizyme’s cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.
Manager Medical Information – Based in Cambridge, MA and reporting to the Senior Director of Scientific Communications this role will be primarily responsible for generating and obtaining internal approval for standard and customized medical information content to fulfill unsolicited Medical Information requests from both healthcare professionals (HCPs) and non-HCPs. This role will also be responsible for oversight of the Medical Information (MI) Call Center, which includes, managing escalated questions from call center staff, monitoring the medical information database used by the call center to ensure that the database is accurate and up to date, and training of the call center staff. This role will also create an annual review schedule for all materials used by the call center and manage the internal review process for those materials. Additional duties will include monitoring inquiries to find requests and trends that would be of interest to the wider Epizyme organization; continuous process improvement; maintaining a state of audit readiness, as well as supporting the medical/scientific review of promotional, non-promotional, and research and development materials.
- Generate MI material (e.g. standard and custom response letters, Frequently Asked Questions, handling and administration guidelines, stability guidelines, etc.)
- Write, review, and respond to out of scope requests by performing critical literature evaluations and researching previous out of scopes.
- Lead the resolution of escalated questions from professional call center and coordinate teams of individuals to address HCP and consumer concerns
- Assist with the development and maintenance of AMCP dossiers
- Manage the internal review process for all new MI materials through the Medical Review Board (MRB) as well as the annual review schedule for approved materials
- Ensure develop materials adhere to relevant SOPs and local laws/codes of practice.
- Provide on-going training to call center agents and other relevant individuals on new or updated Medical Information content
- Monitor call center inquiries for unique questions, common questions and trends and ascertain the need for new materials to address them, e.g., manuscripts, FAQs, new standard response letters, and communicates to the wider business, as appropriate
- Provide monthly and quarterly metrics to internal stakeholders
- Participate in quarterly internal audits of the MI process to ensure a state of audit readiness
- Monitor the quality and accuracy of the MI responses provided by the call center and identify necessary corrective actions or training required to address any deficiencies
- Assist with monthly and quarterly budget tracking
- Adhere with legal, regulatory, market access, and company codes and standards
- Complete all mandatory trainings on time
- Support the review of promotional and non-promotional material from a medical/scientific perspective for the Promotional and Medical Review Boards
- Perform ad hoc literature searches and assist in ad hoc medical affairs projects, including, but not limited to creation of scientific materials (slides, abstracts, etc.)
Qualifications and Capabilities:
- PharmD and minimum 2 years of experience in medical writing or medical communication activities or demonstrated proficiency of the related skill set; or BPharm and minimum 5 years of experience in medical writing or medical communication activities or demonstrated proficiency of the related skill set
- Prior industry experience in a post-marketing setting (desirable)
- Ability to understand and summarize clinical data and navigate clinical trial protocols and clinical trial reports
- Ability to perform literature searches
- Excellent written and oral communication skills, as well as the ability to effectively collaborate and problem solve with diverse members of the organization
- Ability to quickly adapt to changing business priorities
- Receptive to receiving and quickly implementing constructive feedback
- Strong computer skills, including Outlook, Word, PowerPoint, and Excel
- Travel domestically up to 10% of the time
- Interest in taking on special projects as needed
- Understanding of HIPAA and importance of privacy of patient data
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.