Scientist Writer
Analytical Bio-Chemistry Laboratories, Inc - Columbia, MO

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Overview:
Since 1968, ABC Laboratories has delivered expert scientific support to companies working to improve human and animal health. As a member of the ABC team, you’ll work alongside respected technical experts dedicated to scientific excellence in a process driven regulatory compliant environment. Our laboratories are modern. Our instrumentation is state of the art. And our business is thriving, creating important career opportunities. More than 400 people are building their careers with ABC Laboratories. See what it’s like to do what you love and love where you live! Visit www.abclabs.com to learn more about our company and our community.

The Scientist Writer writes and prepares complex original scientific reports based on the end-of-study results of laboratory activities for clients. Writes, reviews, and finalizes scientific reports including all data, chromatograms, technical content, and ancillary information according to regulatory requirements and project timelines. Works closely with scientific staff, study directors/principal investigators, and project managers to ensure expected client deadlines are met and expectations for quality reports are surpassed.

Job Duties and Responsibilities:
Demonstrated ability to comprehend scientific study organization. Knowledge or experience working in a United States FDA, CGMP, or GLP environment a plus.

Ability to interpret documents written in a language other than English, a plus.

Prepares and writes complex scientific report documents using own knowledge and expertise with advanced scientific practices and principles, from raw and/or processed data. Reports may include components such as stability, release, comparability, method development, method validation, and others.

Determines best presentation for raw data and may assemble raw data in intermediate tables and graphs. Resultant data presentation may be incorporated into poster presentations, peer-reviewed journal articles, and other forms of reports.

Writes, compiles, analyzes, and summarizes data from other sources, as needed.

Reviews study data, as appropriate, for consistency and scientific integrity.

Edits, rewrites, and/or prepares drafts, as needed, of designated scientific documents for project teams and clients.

Ensures regulatory compliance by integrating various sources of information into appropriate style.

Edits and formats ABC Laboratories’ study documents and scientific reports/client-specific reports as well as proofreading for accuracy, consistency and professional appearance and compliance with scientific report writing guidelines, while still meeting all deadlines.

Manages compilation of the components of complex submissions. May provide supervision to Report Specialists by managing work flow and providing review of reports.

Assists in the creation and formatting of technical documents for the company. Creates and develops templates for division-wide use with consistent style and formatting to support professional presentation of scientific reports.

May advise scientists and other scientific professionals when technical problems require attention.

Performs peer-review of data as needed.

Develops specified formats (templates) as required and in compliance with document control procedures and other appropriate policies and practices.

Provides guidance to Scientists on formatting of report, protocol, method, summary report documents and maintains the templates for the various scientific and technical documents.

Strives to improve own level of competence through skill development. Maintains a current training record. Stays current on reading of Standard Operating Procedures. Attends all required educational and other mandatory meetings as required and/or directed.

Maintains and/or enhances the self-esteem of others through listening and responding with empathy and clear transmission of information. Answers inquiries accurately and in a timely manner.

Respects the rights of clients and employees; maintains confidentiality in all client and employee matters.

Works collaboratively with others to maintain a safe environment. Maintains awareness of accident prevention practices and uses appropriate personal protective equipment. Maintains a clean work area.

Adheres to Management expectations of production and personal efficiency.

Maintains accurate records for all data collection utilities, including time records according Project Web Access or other department/division requirements.

Performs other related duties as required and directed.

Education and Experience:
Bachelor’s degree in related discipline (Chemistry, Life Sciences, Biochemistry, Pharmaceutics, etc.) and at least 5 years of related experience or an equivalent combination of education and experience.

Master’s degree in related discipline (Chemistry, Life Sciences, Biochemistry, Pharmaceutics, etc.) and at least 3 years of related experience or an equivalent combination of education and experience.

PhD degree in related discipline (Chemistry, Life Sciences, Biochemistry, Pharmaceutics, etc.) and at least 1 year of related experience or an equivalent combination of education and experience.

Previous laboratory experience preferred.

Specialized Knowledge, Skills or Training:
Demonstrated ability to comprehend scientific study organization.

Knowledge or experience working in a United States FDA, CGMP, or GLP environment a plus.

Ability to interpret documents written in a language other than English, a plus.