Sr. Associate Of Publishing - Regulatory Affairs

Job Type
Full-time
Description
Sr. Associate of Publishing
ABOUT MEITHEAL PHARMACEUTICALS
Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectables and, as of 2022, has expanded its focus to include fertility, biologics, and biosimilars. Meitheal currently markets 50 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of April 2023, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 21 products planned for launch in 2023, and an additional 20 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked among the top 100 Crain's Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for - Meitheal (Mee• hall): working together toward a common goal, for the greater good.
The Sr. Associate position is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers and ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required. This is a hybrid position, our employees come into our Chicago office (near Rosemont) two days per week.
Essential Duties and Responsibilities
Essential Duties and Responsibilities include the following:

• Supports the implementation of necessary Regulatory publishing systems, including assistance with validations, qualifications, and verifications of the systems.
• Supports the preparation and implementation of Publishing Operations processes and standards.
• Support all pre and post approval submissions.
• In collaboration with the publishing operations leader, publishes high quality submissions and ensures all components meet eCTD format requirements.
• Development and Implementation of a File Transfer system, FTP Server.
• Performance of high-level formatting in both word and PDF files, including creating bookmarks, hyperlinks, file optimization, optical character recognition, etc.
• Reviews submissions for compliance with technical requirements.
• Submits eCTD submissions through the ESG FDA gateway.
• Inputs information about submissions into internal databases/systems per internal requirements and procedures.
• Develops and maintains understanding of relevant regulatory requirements for US submissions.
• Timely and effectively supports and troubleshoots the Electronic Submission System.
• Mentor publishing associates and team members as required.
• Presents work to various internal and cross-functional teams.

Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Assimilate to changing environments.
• Ability to prioritize and multitask.
• Be organized and detailed orientated.
• Have a sense of urgency to meet all required deadlines.

Education and/or Experience

• Bachelor's degree in life sciences/IT from a 4-year college or university with some experience and/or training in computer systems; or equivalent combination of education and experience.
• 3+ years' experience in a pharmaceutical Publishing Associate capacity.

AAP/EEO Statement
Equal Opportunity Employer Minorities/Women/Veterans/Disabled.