R&D Technical Writer

Summary of Position

The R&D Technical Writer position will report to the Senior Director of Upstream Development. The successful candidate will serve as a key technical team member and will support or lead technical aspects of projects and will support the analytical development team in drafting technical documents and development reports in support of regulatory filings.

Work Schedule: Monday - Friday 8:00am - 5:00pm. Hours could be adjusted.

Essential Functions

• Prepares written documents, including reports, articles, formal proposals, memoranda, and formal correspondence.
• Contributes to various US, EU and rest of world (ROW) registrations.
• Author and create dossier content from source documentation for registrations and provide writing support for technical reports.
• Use experience in Process Development to identify technical inconsistencies and participate in resolution.
• Strong written and oral communication skills to summarize studies from reports, presentations, and notebooks and a demonstrated ability to document information in a clear and concise manner.
• Support new product development and life cycle management of existing products as needed.

Requirements

• Bachelor's degree in Chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field.
• Relevant experience preferred.
• Demonstrated knowledge of pharmaceutical manufacturing and process development.
• Knowledge of product lifecycle – Product and process development, clinical trials, validation and regulatory submissions, commercial GMP manufacturing.
• Behavioral requirements for success in this position include self-starter, strong work ethic, excellent written and verbal communication skills.

Working Conditions:

• Standard office environment coupled with approximately 20% time in radiopharmaceutical manufacturing and laboratory environments.
• Must be willing to wear a variety of personal protective equipment.
• Willingness to work in a team-based environment.
• Close attention to detail required.
• May be required to sit or stand for long periods of time while performing duties.
• Must be able to work outside of regular work hours.
• Willingness to work in a plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities also include the ability to lift, walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
• Must possess good hand-eye coordination.