The Scientific Writer/Reviewer I provides project/study support through review, technical writing, and report generation for the laboratory studies. Assignments are of general complexity, where judgment and initiative are required to resolve problems and make recommendations. The Scientific Writer/Reviewer I must have some laboratory background and have an understanding of the theoretical basis of methods and experiments. He/She will normally work independently of instruction on routine work and with some general instruction on new assignments. The Scientific Writer/Reviewer I will review research and development documents/data ensuring that the studies and information provided are scientifically sound.
Key Job Responsibilities:
Generates basic study protocols under the guidance of laboratory leadership.
Generates various types of client reports, including but not limited to: stability reports, method validation reports, method transfer/verification reports.
Performs second check of data to ensure compliance with testing, product specifications, and/or protocol acceptance criteria.
Resolves moderately complex questions and refers more complex questions to higher levels.
Works with internal groups to initiate, write, and then to ensure the approval of test procedures, as needed, for project timelines.
Organizes data into clear and concise professional presentations.
Maintains consistent, accurate, and up-to-date notes and files.
Effectively performs duties, on schedule, with accuracy and competency.
Complies with company polices and GMP regulations.
May aid in training other staff within the same job function.
May interact directly with client individually or in groups to address straight-forward requests, obtain timelines for deliverables and provide status updates.
Assists with laboratory and quality improvements.
Works the hours necessary to meet scheduling commitments.
Essential Job Requirements:
• BS/BA Degree in Chemistry/Biology or related science with a minimum of 2 yrs. of experience of technical writing documents for a CMC analytical laboratory or GMP quality unit.
• GMP procedures.
• GMP document requirements.
• ICH Guidelines/Regulations.
• Computer proficient.
• Word processing, reports, and presentation creation.
• Strong oral and written communication.
• Works well in team setting.
• Laboratory Background.
• Proven skill in technical writing.
Supervision Received: General
A Scientific Writer/Reviewer I should be able to exercise independent judgment in developing professional level protocols and reports that are consistent with pharmaceutical industry standards. Independently starts on next assignments in the assignment list and may seek management direction in the creation of reports that are complex in scope or to set priorities.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit. The employee is occasionally required to stand; walk and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds, occasionally lift and/or move up to 25 pounds and rarely lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
Environment and Protective Equipment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts and vibration. The noise level in the work environment is usually very quiet.
LIMITATIONS AND DISCLAIMER
The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required for the position.
All job requirements are subject to possible modification to reasonably accommodate individuals with disabilities. Some requirements may exclude individuals who pose a direct threat or significant risk to the health and safety of themselves or other employees.
This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow job-related instructions and to perform other job-related duties requested by their supervisor in compliance with Federal and State Laws.
Position Title: Scientific Writer/Reviewer I
Requirements are representative of minimum levels of knowledge, skills, and/or abilities. To perform the job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.