Senior Associate, Regulatory Operations
770 Lindaro Street San Rafael, CA 94901
Bayside Solutions is seeking a Senior Associate, Regulatory Operations to be part of our client’ s team in San Rafael. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Senior Associate, Regulatory Operations
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- This temporary position’ s primary focus is the formatting, publishing, transmission and archival of submissions to Regulatory Agencies.
- The candidate must interact with personnel from Regulatory Operations, Regulatory Affairs, authoring departments (including but not limited to, Quality, Clinical, Nonclinical, etc.) and project team members from client as well as Partner Company (ies).
- Technical Support: Able to answer most technical questions for many submission types. Able to troubleshoot and resolve some issues with critical computer application systems, e.g., MS Word and InSight Publisher.
- Group Representation: Attend RegulatorySub team meetings with main publishing contact to provide support.
- Project Management and Communication: Able to answer some technical questions for many submission types
- Regulatory Intelligence: Advanced understanding of regulations and guidance associated with submissions.
- Formatting and Publishing: Able to independently format, publish, transmit and archive all submission types. Develop templates.
- Uses professional concepts and company’ s policies and procedures to solve a wide range of moderate problems in imaginative and practical ways.
- Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Summary of Qualifications:
- Bachelor’ s Degree desirable.
- The candidate should have at least 3 years of experience in Regulatory Operations
- Must be certified in InSight Publisher or be able to provide training completion certificates from Liquent
- Basic computer skills in MS Office and Adobe Acrobat, experience with scanners and copiers, able to multi-task and set priorities, pay close attention to details, work in team environment.
- Computer skills in InSight Publisher and Acrobat plug-ins such as ISI Toolbox, ability to publish routine submissions.
- Work with functional areas to coordinate filings and have the knowledge and experience to publish more complex submissions
- The employee may frequently be required to sit and talk or hear.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.