Tech Writer III Formulation RD, Amneal Pharmaceuticals
Full Time, Brookhaven NY
Amneal Pharmaceuticals’ Formulation Research & Development department located in Brookhaven, NY is seeking to fill a Technical Writer III position with the following job responsibilities:
- Preparation and review of documentation for ANDA filing for solid oral dosage forms including immediate and modified release systems under the guidance of project leaders. These documents include master batch records for development, exhibit and scale-up batches and various documents that are part of the CMC section of the ANDA filing.
- Writing and reviewing technical reports relevant to the projects.
- Working effectively with formulators and Regulatory Affairs team to deliver documents on time.
Job requirements and skills:
- Knowledge of FDA regulations, SOP and cGMP guidelines; some prior experience in research activities related to product and process development of solid oral dosage forms preferable.
- Excellent oral/written communication skills and possess strong commitment to team dynamics.
- Thoroughness in reviewing records, technical writing, scheduling and meeting deadlines.
- Ability to adapt to changes in assignments, to be flexible and willing to work extended hours including weekends when required.
- Ability and desire to work efficiently and productively in a multi-tasking environment on a daily basis, independently and with minimal supervision.
- Ability to be a self starter and motivated to develop creative solutions to obstacles.
Education requirement: Bachelor’s or Master’s Degree in a scientific field.
Work experience: 3-5 years in technical writing/regulatory affairs/pharmaceutical industry.
Qualified candidates should email a resume and a cover letter including salary history and requirements to Daniel Lodato, Dlodato@amneal.com
Contact: 631-952-0214 ext 162