Report Writer
Title: Report Writer
Location: Chicago, IL, onsite
Reports to: Technical Report Supervisor
Full-time
Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.
Our Chicago, IL site provides toxicology testing and research laboratory services and specialized pre-clinical studies in support of pharmaceutical and biotechnology products.
Position/Job Summary:
This position supports toxicologists in their preparation and presentation of reports, protocols or other documents associated with the evaluation of the safety and/or toxicity of various materials (e.g., pharmaceuticals, chemicals, etc.). The Report Writer prepares documents from information provided by personnel and/or subcontractors to be submitted to Study Sponsors. In addition to preparation of text, this position requires tabulation and summarization of data as well as some interpretation of results. Writers receive assignments from Study Directors and Management and are supervised by the Technical Writing Supervisor.
Roles & Responsibilities:
- Generating, formatting, and, reviewing pre-clinical main study reports and sub-reports.
- Coordinating and facilitating the compilation of report information from the Frontage study team (e.g., Study Directors, Study Supervisors, Management, and Quality Assurance personnel), Principal Investigators, and Contributing Scientists.
- Maintain consistent formatting across all Sponsor-facing documents by adhering to current style guidelines.
- Set up and troubleshoot table template generation for data outputs as well as quality check outputs for formatting/data errors.
- Compile, organize, and present collected study data in a logical manner within summary and appendix sections of reports/sub-reports, as well as appropriately creating/linking in-text references to appended data.
- Maintaining technical information in both electronic and paper formats.
- Generating new documents from pre-established template files following pre-established guidelines in their implementation and maintenance, or creating/maintaining new templates as needed.
- Tracking the preparation of report or other documents (e.g., protocols, study specific procedures) as well as the progress of study data as it is prepared for reports.
- Maintaining open lines of communication within the reporting writing team, Study Directors, Quality Assurance, and Management regarding the status of reports/documents and data processing.
- Identifying and resolving problems related to the production of reports and other documents.
- Maintaining an understanding of pertinent governmental regulations (e.g., FDA, EPA, OECD, ICH, etc.), data handling best practices, and Sponsor guidelines.
- Delivering assignments on time and adjusting regular business hours to accommodate deadlines.
Education, Experience & Skills Required:
- Must have a minimum of a BS/BA degree in a science/related discipline or prior experience that contributes directly and significantly to the individual’s technical writing competence.
- Experience with electronic document management; proficiency in Microsoft Word (general operation/document formatting) and Excel required.
- Familiarity with Adobe Acrobat and Photoshop, or equivalent, for report compilation and finalization processes preferred.
- Must possess strong organizational, grammatical, editorial/proofreading, reading comprehension, and critical thinking skills.
- Must be able self-start independent work, cooperatively interact with study team members toward common goals, and to work on multiple projects concurrently.
- Must possess excellent communication skills to effectively interact with other personnel.
- Familiarity with adherence to protocol/SOP-specified parameters preferred.
Salary: $21.63-$25.97/hour
Benefits:
- 401k Employer Match with immediate vesting
- Vision Insurance
- Medical and Dental Insurance with multiple coverage options
- FSA (Medical, Dependent Care, and Commuter)
- Short Term Disability
- Long Term Disability
- Life Insurance
- Generous Paid Holidays and PTO
Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.
Skills Required
- Bachelor’s degree in a science or related discipline, or prior experience that directly and significantly contributes to technical writing competence
- Experience with electronic document management
- Proficiency in Microsoft Word, including document formatting
- Proficiency in Microsoft Excel
- Strong organizational, grammatical, editorial, proofreading, reading comprehension, and critical thinking skills
- Ability to work independently and collaborate with study team members
- Ability to manage multiple projects concurrently
- Excellent communication skills
- Familiarity with Adobe Acrobat and Photoshop, or equivalent tools
- Familiarity with protocol- and SOP-specified parameters
What We Do
Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.
