R&D Technical Writer
The individual is responsible for writing Standard Operating Procedures, Technical Transfer Documents, Pre-Development and Development reports. Manages documentation compliance and change control for R&D. Execute all functions in accordance with current FDA regulations, ICH guide lines, USP methodologies, cGMPs and SOPs. Must perform all work independently with minimal supervision.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Include the following. Other duties may be assigned.
– Develops, writes and reviews/updates R&D SOPs.
– Writes Development protocols and reports for R&D.
– Prepares documentation for submission of new ANDA filings.
– Assists in the response to FDA deficiency letters for ANDA filings for answering Pharmaceutics related findings.
– Prepares various summary forms for Pharmaceutics related projects as well as graphs, charts and statistical analysis for establishing product specifications.
– Designs, develops and implements databases to track key project deliverables and resource allocation within Pharmaceutics and updates on an on-going basis.
– Implements Document Management in R&D.
– Handles research and writing projects.
– Implements Change Control management in R&D.
Requirements:
ESSENTIAL KNOWLEDGE, SKILLS AND ABILITIES:
– cGMPs, Food and Drug Administration and other regulatory compliance requirements.
– Pharmaceutical principles, practices and applications.
– Documentation and technical writing principles and practices.
– English usage, spelling, grammar and punctuation.
– Related business, scientific and personal computer hardware and software applications.
– Communicating clearly and concisely, both orally and in writing.
– Strong organization skills, attention to detail, and the ability to work in a team fast paceenvironment.
EDUCATION AND EXPERIENCE:
B.S/M.S/Ph.D. in Analytical Chemistry or related discipline with at least 7 years of general laboratory experience, including 3 years of technical writing experience in a pharmaceutical industry.
Akorn, Inc. is a niche pharmaceutical company that develops, manufactures and markets generic and branded prescription pharmaceuticals as well as animal and consumer health products. We specialize in difficult-to-manufacture sterile and non-sterile dosage forms including: ophthalmics, injectables, oral liquids, topicals, inhalants, and nasal sprays. Akorn markets its products to retail pharmacies, ophthalmologists, optometrists, physicians, veterinarians, hospitals, clinics, wholesalers, distributors, group purchasing organizations, and government agencies.
Akorn, Inc. is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
