South San Francisco, CA | Contract
Bayside Solutions is seeking a Regulatory Assistant to be part of our Client’ s team in South San Francisco. This is an opportunity to work with a local biotechnical company focusing on the discovery, development, manufacturing and commercialization of medicines to treat patients with serious or life-threatening medical conditions.
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.
- An opportunity to join a patient-focused organization that is driven to develop and commercialize novel drugs for treating rare diseases.
- 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:
- Manage the CMC aspects and associated documentation of clinical trials.
- Project support including database entry and analysis, preparation of technical documents, submission coordination and management.
- Team support to enable effective and efficient team working including planning, tracking and facilitating meetings, documenting decisions and actions.
- Independently manage multiple priorities and assignments simultaneously.
- Manage administrative work associated with change control.
- Bachelors degree in science or engineering required, Masters degree preferred.
- Knowledge of manufacturing or technical development processes for biologics, cGMPs and compliance experience is required.
- Knowledge and experience of clinical trial regulatory submissions (technical documentation) and associated regulatory requirements is required.
- Experience assessing the regulatory relevance of technical changes is required.
- Ability to work independently to appropriately prioritize simultaneous assignments.
- Ability to work well in a collaborative team environment and communicate effectively.
- Strong interpersonal skills, and the ability to work well with others in a proactive, positive and constructive manner.
- Have excellent written and verbal communication skills.
- Good working knowledge of MS Office Word, Excel and Google drive.