Report Writer I

Job description

Report Writer I

Your  Role:

 

Responsibilities will include but are not limited to:  Review lab data/ workbooks and accurately represent the data in the final report;  Identify and/or resolve issues with study raw data/ information appropriately with relevant staff;  Monitor department’s performance in the reporting process including tracking deadlines On Time Delivery (OTD) and Document Error Rate (DER) metrics;  Coordinate and plan work within technical team to meet and improve deadlines;  Obtain required signatures and transfer study reports to the appropriate personnel;  Communicate daily with other departments to resolve outstanding issues;  Assist in the preparation of SOPs and investigation reports relevant to area of report writing responsibility;  As appropriate generate, control and track revisions to study documentation including statements of work, protocols, protocol and report amendments, lab records, protocol and report templates;  Track status of laboratory testing and update Excel study tracking files, data trending as appropriate.

Who You Are:

 

Minimum Qualifications:

·  Bachelor’s Degree, preferably in a scientific discipline such as Biology, Chemistry, etc.

 

Preferred Qualifications:

·  Previous experience in an FDA regulated environment
·  Previous technical writing experience
·  Basic knowledge of GLP/GMPs as applicable to assigned tasks
·  Ability to write routine reports with proper grammar, a professional appearance and language which accurately reflects what occurred and flows so that it is easily read and understood
·  Intermediate technical knowledge and ability to analyze data of some scientific complexity
·  Basic knowledge of applicable computer systems (i.e. Excel, Word, PowerPoint, LIMS, BRIQS, etc.)
·  Ability to perform and understand scientific calculations
·  Effective communication both written and verbal

 

RSRMS

Job Requisition ID: 199774

Location: Rockville

Career Level: C - Professional (1-3 years)

Working time model: full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

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