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Medical Writer

Epizyme, Inc.

This is a Full-time position in Cambridge, MA posted February 23, 2021.

nnEpizyme, 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.

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 nnEpizyme has assembled a world-class team with a passion for scientific innovation and a commitment to developing novel epigenetic therapies.

In addition to our TAZVERIK program, Epizyme has an active research and discovery pipeline, Join a dynamic, diverse and fun work environment consistent with Epizymes cultural attributes for success: camaraderie, collaboration, disciplined, innovative, openness, patient-focused and resilient.

nn nn Key Responsibilities: nn Assists in the planning and preparation of high quality clinical and regulatory documents, including clinical protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), updates to regulatory submissions, annual reports, etc., according to company and agency guidelines.

Creates in-text tables, compiles document appendices, attachments, etc.

Conducts research as necessary for each assigned project, including literature searches Works effectively with document management systems and related tools, templates, and procedures in order to ensure efficient production and publishing of documents and dossiers.

Participates in document review meetings to determine the most accurate and appropriate protocol design or interpretation of study results.

Represents Medical Writing on cross-functional teams, including external vendors.

Ensures a consistent style of presentation of documents to maintain quality and ease of review.

Performs quality control (QC) review of CSRs and other submissions and may contribute to pre-publishing activities.

Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and the International Council on Harmonisation (ICH).

Keeps management informed on progress of documents and other project related information.

nn Education & Requirements: nn Bachelors degree in health sciences or related field with 0-2 years of medical writing experience in a pharmaceutical/biotechnology, or CRO environment.

Familiarity with the requirements for preparation of key clinical and regulatory documents Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format.

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, as well as with external partners and vendors Possesses strong written and verbal communication skills 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 searche nnCandidates with 2-4 years of Medical Writing experience and the following requirements may be considered for a Sr.

Medical Writer position:nn 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 nn Epizyme, Inc.

is a vibrant, entrepreneurial EEO employer committed to a diverse and dynamic workplace.