Regulatory Affairs Publisher
Are you looking to be part of something extraordinary and meaningful that is helping thousands of patients across the country every day? NorthStar Medical Radioisotopes is seeking motivated individuals like you to join our rapidly growing team in Beloit, WI. Innovative technology, Opportunities for career advancement, and competitive compensation are just the beginning at NorthStar. In addition to health and life insurance, paid holidays, and paid time off, all NorthStar employees are eligible on Day One for our annual bonus and equity incentive plans.
NorthStar develops, manufactures and distributes radioisotopes that are used daily for patients needing medically important diagnostic imaging tests. Our novel, high technology approaches have enabled NorthStar to be the first company in nearly 30 years to produce the radioisotope Mo-99 in the United States. NorthStar’s processes are non-uranium based and designed to help minimize waste while meeting the highest quality standards. The Mo-99 is used in NorthStar’s RadioGenix® System, an isotope separation platform used by radiopharmacies across the country to produce the imaging radioisotope Tc-99m. NorthStar will scale-up production over the coming months and years and intends to become the industry’s market leader. Beyond Mo-99, we have a pipeline of other novel and medically important isotopes that can further grow our business and provide development opportunities for our employees.Working with this novel and advanced technology is challenging yet rewarding for talented individuals who want to make a difference and be part of an exciting and rapidly growing business. NorthStar’s people drive our solutions and our success, and we are committed to ensuring that we provide fulfilling work experiences and valuable development opportunities.
This Regulatory Affairs Publisher provides support for the preparation, compilation, quality control (QC), retention and submission of regulatory documents to US health authorities using eCTD publishing software. The publisher ensures that documentation and submissions have the correct formatting and are complete and follow relevant Food and Drug Administration requirements (FDA), company Standard Operating Procedures (SOPs), and other directives. They will maintain regulatory submissions, health authority correspondence, and relevant documentation in an appropriate archive location in accordance with regulatory guidelines and internal company standards.
Duties and Responsibilities
- Performs report-level publishing and submission-ready activities in accordance with internal standards and regulatory requirements.
- Maintains and tracks regulatory submission documentation, including regulatory authority correspondence, in an appropriate document management system or hardcopy archive location to ensure regulatory compliance and in accordance with company document standards.
- Maintains and tracks product labeling versions.
- Assures completeness and quality of submissions from the operations perspective. Identifies issues, suggests and implements solutions under guidance, sets priorities within area of purview, and ensures adequate workload balance through interactions with other team leads and management.
- Bachelor’s degree or higher from four-year college or university (preferably in a scientific discipline).
- Minimum of one to two years eCTD publishing-related experience and/or training; or equivalent combination of education and experience.
- Excellent oral and written communication skills, managing timelines, integrity and adaptability.
Location – Beloit
NorthStar Medical Radioisotopes is headquartered in Beloit, Wis. This location is our primary manufacturing site and accommodates all of our corporate functions. Beloit has small city charm, with a lively and renovated downtown, yet is also close to cities such as Madison, Milwaukee, Chicago, and Rockford.
Beloit is a part of the larger South Central Wisconsin/Northern Illinois region, which offers residents and visitors alike a unique blend of urban opportunities and rural, natural beauty. The area, therefore, offers collections of natural, educational, artistic, and historical attractions alongside a wide variety of sporting and social opportunities. There are several cities and many towns within a reasonable commute of Beloit, which offer a wide choice of residential styles and a large number of school district choices for those considering relocation.
NorthStar Medical Radioisotopes is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age disability, protected veteran status or other characteristics protected by law.
If you are interested in applying for this position, please forward your resume to [email protected] with the position title in the subject line.
Regulatory Affairs Publisher – 1800 Gateway Blvd. Beloit, WI 53511