Location: Maryland Heights, MO
Company: Curium
With manufacturing facilities across Europe and the United States, Curium delivers SPECT, PET and therapeutic radiomedical solutions for life-threatening diseases to over 14 million patients annually. The name ‘Curium’ honors the legacy of pioneering radioactive researchers Marie and Pierre Curie, after whom the radioactive element curium was named and emphasizes our focus on nuclear medicine.
The tagline ‘Life Forward’ represents our commitment to securing a brighter future for all those we serve: An enhanced quality of care for our patients. A trusted partner to our customers. A supportive employer to our valued team. Summary of Position The R&D Technical Writer position will report
to the Senior Manager of Downstream R&D. The successful candidate will serve as a key technical team member and will support 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, 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. Must maintain operational compliance with US and international regulatory agencies and guidelines (i. e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, c GMP, etc. ). Requirements Bachelor of Science degree in Chemistry, Chemical Engineering, Biochemistry, Biology, Life Sciences, or related field required.
Work experience considered in lieu of degree. Three years or more of relevant work experience required. Demonstrated knowledge of medical 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: Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment. Material handling devices (e. g. hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed. May be required to sit or stand for long periods of 8+ hours a day while performing duties. Must possess good hand-eye coordination; close attention to detail is required. Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants. Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.
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