R&D Technical Reviewer
Technical Reviewer will review all technical documents, data, protocols, reports, methods, specifications, notebooks for ANDA/NDA filing. This role will be a part of the Research and Development group located at Vernon Hills, IL.
Responsibilities will include
– Reviewing all formulation and analytical studies documents
– Review work of other writers (in-house or consultant) for accuracy, quality, focus, and adherence to format and stylistic requirements, review data to determine the appropriate tabular and textual formats, and the clarity, logic and order of presentation.
Skills/Knowledge Required
– Extensive experience reviewing all types of R&D documents for regulatory filing
– Knowledge the analytical and formulation development process
– Experience in reviewing ANDA filing documents
– Understanding of all study documents: Formulation development protocols and reports, method validation protocols and reports, test methods, specifications, pharmaceutical development reports etc.
– Familiarity with analytical chromatographic software and knowledge of chromatography techniques
– Excellent grammatical and communication skills, both written and oral
– Knowledge of FDA and ICH guidelines
– Ability to work with multiple complex projects at a time
– Ability to anticipate and resolve problems
– Experience working with automated data solutions in pharmaceutical documents
– Experience in working pharmaceutical lab
– Proficiency in data interpretation
– Sound organizational skills
Requirements:
BS degree in science related fields (Masters preferred) with 7+ years in the pharmaceutical industry experience of reviewing technical documents.
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.
