CBSET, Inc Hiring for Preclinical Medical Writer Job at Lexington, MA Full Time

We at CBSET are committed to providing exceptional quality deliverables, and this can only be achieved through hiring exceptional technical talent. By working as a Medical Writer, you will be part of a collaborative effort with our clients to advance biomedical research through innovative, high-quality services. In addition, CBSET is proud to offer a generous benefits package, which includes health, dental and vision plans, life insurance, short-term and long-term disability, and an opportunity to participate in a 401(k) plan.

To independently facilitate and oversee the coordination, assembly, writing, editing and quality control of study/data reports, and/or protocols, which accurately reflect the study data and fulfill all protocol and GLP requirements. Additionally, involved in the development of report and data structure and presentation formats with preparation of text tables and/or associated graphs for reports and/or presentations.

Responsibilities:

• Coordinate with and assist Study Director in the presentation of data and writing of report
• Organize the overall layout of study from constituent parts (sub-reports, etc.)
• Assure the completeness of collection, assembly and organization of raw data
• Ability to work within established timelines
• Write materials and methods section of study reports, evaluating the study data to assess whether the methods documentation meets the requirements of the study protocol.
• Manage the organization of report sections including formats, presentation of data (i.e., tables, graphs, etc)
• Prepare file-searchable PDF version of the report deliverable (i.e., bookmarks).
• Prepare report and electronic files for submission to the DSU.
• Participate in study-specific pre-initiation meetings; anticipate reporting issues and suggest courses of action for data collection enhancements or protocol edits.
• Proofread/copyedit study protocols prior to submission for Study Director signature.
• Ability to perform quality control on draft editions of reports, other documents/data and sub‑reports (i.e., assisting in the generation of the Veterinarian sub-reports).
• Coordinate and communicate with participating departments, sponsors and outside vendors to help ensure timely delivery, organization and generation of the report
• Assist in the production and/or write scientific publications
• Assist in development of formats, templates, and general guidelines for documentation.
• Participate in departmental or interdivisional process improvement and training initiatives.
• Perform all other related duties as necessary/assigned

Qualifications:

• Education: Bachelor’s degree in biological sciences, technical writing or equivalent field (with significant course work in biological sciences)
• Exceptional experience in a related field could substitute for the education requirement
• Experience: Minimum four years experience in a regulatory pre-clinical or clinical testing environment with involvement in medical writer-related activities
• Exceptional experience in related preclinical/clinical areas could substitute (e.g., study coordination or data coordination)
• Certification/Licensure: Driver’s license

Other:

• Knowledge of domestic and foreign GLP regulations as they relate to reporting requirements and to study conduct
• Proficiency with Windows-based word processing, spreadsheets and presentation software
• Ability to multi-task with good communication, interpersonal, and organizational skills
• Ability to adjust priorities in order to adhere to stringent deadlines
• Ability to perform under pressure in a fast-paced, multi-task, deadline-oriented environment
• Advanced working knowledge of Microsoft Word, Excel, and Adobe Reader
• Must be skilled in using and developing document templates’

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Work Remotely

• No

Job Type: Full-time

Pay will also depend on experience level.

Job Type: Full-time

Pay: $50,000.00 – $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Tuition reimbursement
• Vision insurance

Schedule:

• 8 hour shift

Work Location: One location