QA/RA Document Control Specialist
Frequency Therapeutics (Nasdaq: FREQ) is a leader in the development of medicines designed to activate progenitor cells within the body to treat degenerative diseases. The company’s lead product candidate, FX-322, is a potential disease modifying therapy designed to regenerate damaged auditory hair cells to improve hearing function. In a Phase 1/2 study of FX-322, the company observed clinically meaningful improvement in key measures of hearing function in patients with sensorineural hearing loss, the most common form of hearing loss. A Phase 2a study is anticipated to begin in Q4 2019. The Frequency progenitor cell activation (PCA) approach stimulates progenitor cells to create functional tissue and the company is researching an array of additional degenerative diseases where PCA may be applied, including a discovery program in multiple sclerosis.
The QA/RA Document Control Specialist reports to the Vice President of Regulatory Affairs and is responsible for the timely publishing and implementation of SOPs and regulatory submission documents. Responsibilities include archiving documents from regulatory, quality, manufacturing, preclinical and clinical functions, and technical support to QA/RA functions. The ideal candidate will be highly proficient in Master Control.
Key Responsibilities Include:
- Implement and maintain eDMS system as SME for publication and storage of quality and regulatory documents including template development and maintenance
- Provide publishing, editing and formatting support for quality and regulatory documents, including preclinical and clinical documents in eCTD format, standard operating procedures, and ancillary reports, validation documents and methods
- Support quality and regulatory document preparation, coordination of multidisciplinary reviews, and maintenance of logs, planners and libraries (e.g. scan, print, file)
- Maintain knowledge of and trends in health authority procedures and guidance documents regarding electronic submissions
- Coordinate with QA/RA lead and functional leads to coordinate writing, review and publication across functions
- Provide additional administrative and planning support as needed.
- BS Degree in Life/Health/Technical Sciences desired or equivalent experience in document control and/or combination of experience and training
- 3 or more years’ experience in medical device or drug quality systems and regulatory submissions required
- Must be highly proficient in MS Office (emphasis on MS Word), Adobe Acrobat (version 5.0 or higher) and document publishing tools
- Must be experienced with electronic document management system, such as Master Control
- Strong software troubleshooting skills highly desirable
- Ability to work both independently with minimal direction, and within project teams, to meet group goals
- Professional communicator with the ability to interact effectively with a variety of personnel including medical, scientific, and manufacturing staff
- Exceptional organizational skills with the ability to prioritize deadlines, maintain focus and monitor progress on assigned tasks, while working independently.
A fundamental belief held by the Frequency Therapeutics team is that we have the best chance to achieve our mission by bringing together our collective problem-solving and leadership skills into a single, collaborative front. We look for people who envelop competence and self-awareness, retain the courage to state thoughts, wants and needs, and have the ability to make good judgment calls and decisions. We want people who are undeterred by uncertainty, convert adversity into opportunity, and turn understanding into action while driving motivation for the team at large.
We offer a competitive compensation and benefit package with opportunities to participate in groundbreaking technology. For consideration, please submit cover letter and CV.
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QA/RA Document Control Specialist