Senior Medical Writer (Remote work option)
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 patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma who are not eligible for complete resection. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in an ongoing confirmatory trial. 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.
**Remote work option for candidates who reside in New England**
- Plan, prepare, write, edit, format, and finalize high quality non-clinical, clinical and regulatory documents, including clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), aggregate safety reports (such as development safety update reports [DSURs]), etc., according to company, International Council on Harmonization (ICH), and health authority guidelines.
- Collaborate with subject matter experts on the preparation and/or editing of specialty content of clinical or regulatory documents or submissions, such as pharmacokinetic, pharmacodynamic, and non-clinical/toxicology reports
- Assist in developing strategy for and managing the medical writing component of complex projects with multiple deliverables, such as Investigational New Drug Applications (INDs), narrative projects, and New Drug Applications (NDAs).
- Coordinate the internal team review and independent peer and quality reviews of assigned documents.
- Develop, maintain, and drive document finalization timelines.
- Conduct research as necessary for each assigned project, including literature searches
- Work effectively with document management systems and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers.
- Represent the Medical Writing function on cross-functional teams, including external vendors.
- Contribute to the design and maintenance of templates/standards for Medical Writing deliverables in accordance with ICH guidelines and medical writing best practices.
- Ensures a consistent style of presentation of documents and adherence to standard operating procedures (SOP), good clinical practice (GCP), and the ICH to maintain quality and ease of review.
- Perform peer and quality control (QC) review of Medical Writing documents prepared by other writers.
- Keep management apprised of new information and progress on deliverables, including needs for and risks to their successful and timely completion.
- Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested.
- Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.
- Keep abreast of industry developments, and collaborate with and support department leadership to ensure compliance, continuous improvement, and high standards for quality and productiveness.
- Mentor less experienced medical writers.
Education & Requirements:
- Bachelor’s degree in health sciences or related field with 2-4 years of medical writing experience in a pharmaceutical/biotechnology or CRO environment, or equivalent combination of education and experience. Advanced degree preferred.
- Familiarity with the requirements for preparation of key clinical and regulatory documents
- Working knowledge of ICH and US regulatory requirements is required; working knowledge of other ex-US regulatory requirements is desired.
- Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology
- Ability to interpret and present clinical data objectively in a clear, concise format; ability to help SMEs present specialty (e.g., non-clinical, PK, etc.) information clearly and concisely.
- Demonstrated problem-solving ability, sense of urgency, and ability to prioritize tasks, to work simultaneously on multiple projects, and to independently complete high-quality documents according to tight timelines
- Attention to detail and the ability to work individually, within a multi-disciplinary team, and with external partners and vendors
- Possesses a strong command of the English language, strong written and verbal communication skills, and ability to work effectively in a multicultural environment.
- Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint) and experience and skill performing medical literature searches
- Embrace Epizyme’s core values: camaraderie, collaboration, discipline, innovation, openness, patient-focus, and resilience
Epizyme, Inc. is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.