Technical/Scientific Writer in Biologics, Assays and Technology
Teva Biologics has an immediate opening for a Technical/Scientific Writer to join our Laboratory Operations and Compliance team within Biologics, Assays and Technology Department.
The Technical/Scientific Writer will provide support for deliverables from Potency, Immunogenicity and Pharmacokinetics/Biomarker groups. Work involves hands-on preparation of biologics method validation reports, bioanalytical study reports, related sections or modules within for regulatory submission, and manuscripts for publication. The role requires direct working interface with scientists from the various functions within the Biologics, Assays, and Technology Department. The candidate must be self- motivated, able to work independently and to interface seamlessly with the teams within Potency, Immunogenicity, and PK/PD/Biomarker groups. This position will play a critical role in development of biological therapeutics from early stage research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.
Establish and implement templates for each type of reports according to applicable format and standards for quality and regulatory requirements.
Interfaces and collaborates with various scientist and technical staff to gather data and information for various reports and manuscripts (deliverables)
Plans, writes, organizes, enters and compiles data and related information/documents to support the completion of deliverables from various functions within the department
Determines the scope and timeline of deliverables in order to ensure meeting deadlines and quality standards
Archive applicable records and documentation after completion of deliverables
Participates in preparation and/or review of SOPs
Participates in regulatory training, SOP training, general laboratory/safety training
Advanced degree in applicable disciplines with 3-5 Yrs of related experience in pharmaceutical, biotechnology and/or CRO industry.
Previous experience in technical or scientific writing is required, and previous working experience with bioanalytical and bioassay reports is preferred.
Proficiency in Microsoft Office Suite and SAGE, in editing, written, English and grammar skills, in analytical skills, attention to detail, and ability to perform in a team-based, fast-paced, quick reaction environment and quickly learning new skills and completing assignments with minimal supervision.
The candidate must be a self-starter and be able to work collaboratively in a diverse, fast-paced environment with ability to multi-task with knowledge of industry practices, data integrity and regulatory requirements.
Good communication, interpersonal, and writing skills are required.