Medical Writer

Everest Clinical Research ( Everest ) is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries.

We serve some of the best-known companies and work with many of the most advanced drugs, biologics, and medical devices in development today.

Everest has been an independent CRO since 2004 with a strong foundation as a statistical and data management center of excellence.

Building on this foundation, Everest has successfully developed and established itself as a full-service CRO. Everest’s headquarters are located in Markham (Greater Toronto Area), Ontario, Canada with additional sites in Bridgewater (Greater New York City Area), New Jersey, USA, Shanghai (Pudong Zhangjiang New District), China and Taipei, Taiwan.

Everest is known in the industry for its high quality deliverables, superior customer service, and flexibility in meeting clients’ needs.

A dynamic organization with an entrepreneurial origin, Everest continues to experience exceptional growth and great success.

Quality is our backbone, customer-focus is our tradition, flexibility is our strength that’s us that’s Everest.

To drive continued success in this exciting clinical research field, we are seeking a committed, skilled, and customer-focused individual to join our winning team as a Medical Writer for our Toronto / Markham, Ontario, Canada on-site location, or remotely from a home-based office anywhere in Canada in accordance with our Work from Home policy.

Key Accountabilities :

• Work closely with the Everest project team members assigned to the project to achieve project milestones according to the project timeline.
• Perform Everest internal QC procedures for clinical documents developed by other Medical Writers, such as clinical study protocols, Clinical Study Reports (CSRs;

full, abbreviated, or synoptic), pharmacokinetic (PK) reports, statistical reports, integrated efficacy or safety summaries, patient narratives, manuscripts, posters, and abstracts.

Apply therapeutic area experience and scientific knowledge in the review and include QC checks for protocol-related information, accuracy of in-text numbers and source references, and consistency of document styles and formats.

QC procedures include, but are not limited to, the following : Checking the accuracy of the Table of Contents (TOC) compared to the headings within the report and ensuring proper alignment of TOC styles within the TOC.

Similarly, checking the accuracy of any List of Tables or List of Figures compared to the in-text tables and figures.Checking the accuracy and completeness of abbreviations within the List of Abbreviations compared to in-text abbreviations used in the report and abbreviations used in the statistical tables, listings, and graphs (TLGs).

Verifying that protocol-related information is accurately and consistently applied to the text of the report. Such protocol information includes : study objectives, study design, primary and secondary endpoints, treatments and procedures, and adverse event reporting procedures.

Checking the accuracy of numbers within in-text tables and report text against the source data (e.g., TLGs).Verify the accuracy of references to the source tables and listings.

Ensuring that Word styles are consistently applied throughout the document.Verifying the accuracy of quoted references in the report.

Checking the accuracy of a list of appendices in a report compared to the final appendices produced for the report.

Act as a lead medical writer in the preparation of clinical documents or scientific publications. This includes, but is not limited to, the following : With proper medical and study disease area experience, developing initial document shells or drafts using appropriate and approved templates and adhering to Everest or Sponsor’s writing styles and formats.

Providing appropriate and accurate interpretation of study results based on the provided background materials (e.g., study protocol, Statistical Analysis Plan, Investigator’s Brochure, literature references) and statistical analysis output.

Performing effective editing on assigned medical writing products to refine them, as much as possible and when time permits, before releasing them for internal and external review.

Following the Everest governing documents to obtain review comments on the document drafts from internal (Everest team) and external (Sponsor staff) reviewers.

Ensuring appropriate QC checks have been performed on the medical writing deliverables. Incorporating reviewers’ comments / input into the draft documents and delivering the revised documents for additional review cycle(s).

Following up on the QC findings until they are properly addressed. Finalizing documents for delivery to Sponsors according to the established timelines.

• Perform literature searches to support senior medical writers.
• Perform document e-publishing for CSRs and other clinical / regulatory documents to ensure that the final medical writing product meets specific document publishing requirements and timelines.

Document publishing activities include, but are not limited to the following : Rendering the completed final Word report to PDF.

Acquiring all documents or appendices from the Sponsor and Everest personnel.Applying Everest standards to the specifications of the files added.

Creating hyperlinks and bookmarks and ensuring they have appropriate destinations and properties.Updating the table of contents and applying final pagination

• Perform timely completion of TLG assembly packaging into Word and PDF format for other departmental teams. May perform a lead role in providing these services.
• May serve as the DMC Administrator and / or DMC Secretary and perform hands on administrative tasks for assigned projects, according to Everest’s SOPs.

These tasks include, but are not limited to, the following : Writing the committee Charter and its amendments and circulating for their review, finalization, and sign-off by the committee and Sponsor.

Serving as the liaison between the committee and the sponsor.Planning, scheduling, and coordinating all committee meetings, producing meeting minutes, and assisting the DMC Chair with the Recommendations Letter, according to the Charter.

May assist with the identification, recruitment, and engagement of committee members, including contract negotiations, consultant agreements, and administration of honorarium payments.

May assist with coordinating the preparation of the committee Data Reports by external or internal statistical programming teams and the delivery of the Data Reports and other deliverables to the committee members, according to the Charter.

• Plan and manage deliverables and timelines in accordance with clinical trial project teams’ requirements.
• Keep current on the training of Everest Guidance Documents and with the general requirements or guidelines issued by the pharmaceutical drug trial regulators and ICH.
• Plan and carry out professional development.

Qualifications and Experience :

• Advanced degree, Ph.D. preferred, in Clinical or Medical or Life Sciences, or Master’s degree with substantial experience in the subject matter.
• At least two years' experience in medical writing practice, with experience in the pharmaceutical clinical trial environment.
• Experience with medical writing for clinical study reports for regulatory submission (preferred).
• Experience in multiple therapeutic areas and Phase I through IV clinical trials an asset (preferred).
• Excellent understanding of clinical trials and common clinical trial statistical analysis methods (preferred).
• Demonstrated ability to understand medical information and results; able to communicate effectively, orally and in writing.
• Ability to handle multiple projects and clients.
• Excellent interpersonal and teamwork skills; detail-oriented, customer- and quality-focused.
• Demonstrated experience, knowledge, and understanding of GCP / ICH guidelines, including E3 Structure and Content of Clinical Study Reports.
• Well organized and able to work independently.
• Comprehensive skills in Microsoft Office applications and Adobe Acrobat. Computing skills with TRS Toolbox pharma edition plugin an asset.
Il y a 16 jours