|
|
|
|
|
|
|
|
|
|
|
|
Second
Sight offers a fast paced environment that challenges employees to be both
productive and creative. Team members are encouraged to explore new solutions
to existing problems while, at the same time, remaining focused on the objective
of restoring vision to the blind. Second Sight offers competitive wages and
benefits. If this sounds like the right opportunity for you then please send
your resume to:
Second Sight
Human Resources
12744 San Fernando Road, Building 3
Sylmar, CA 91342
Phone: 818-833-5000
Fax: 818-833-5067
Clinical Data Manager
We are searching for a Clinical Data Manager who possesses good analytical and problem solving skills, excellent organizational skills, adaptable to a changing environment and with excellent communication skills.
The position is responsible for diverse clinical data management functions, including but not limited to the continued development and update of the clinical database, development of routine and on-demand data reports, tables and graphs, data quality control, critical analyses/review of data trends and participation in basic statistical analyses.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
•Perform data entry and audits, as necessary.
•Assist in the development and implement the data management strategies for clinical trials
•Develop and produce routine reports for internal and external circulation
•Prepare data reports, tables and graphs for regulatory submissions, IRB submissions, presentations and publications
•Liaise with research teams on data presentation
•Perform consistency checks and data cleaning functions
•Review data on a regular basis for trends and relationships
•Interact closely with cross-functional groups including but not limited to Information Technology, Regulatory Affairs and Research.
EXPERIENCE, SKILLS AND ABILITIES:
•Strong computer skills (word processing and database programs including Microsoft Access)
•2-3 years experience in data management for product approval trials, preferably with Class III devices, or equivalent combination of education and experience.
•Working knowledge of US/European medical device clinical trial regulations, such as FDA QSR, FDA IDE/PMA regulations, and European Active Implantable Medical Device Directive
Clinical/Regulatory Specialist
We are searching for an experienced, highly-motivated and detail oriented Clinical / Regulatory Specialist to join our team.
RESPONSIBILITIES INCLUDE THE FOLLOWING:
•Assists with the preparation of submissions for US and International regulatory agencies to gain approvals to conduct clinical trials and market company’s products
•Maintenance of regulatory and clinical files including product catalog, complaint files, adverse events, and submissions
•Provides support function for state, federal and notified body inspections of company’s operations
•Prepares and updates product labeling that meets regulatory requirements
•Interacts and interfaces with regulatory agencies.
•Assists with Safety Board oversight of clinical studies
•Contributes to clinical and regulatory in-house procedure development
•Implements complaint handling system and the returned goods authorization system
•Provides assistance in product notification and recall activities
•Works with cross functional teams to provide assistance to meet the company's regulatory and clinical needs
REQUIREMENTS:
•BS degree required, preferably in Engineering, Physical or Biological Sciences
•2-3 years experience in US regulatory affairs, preferably with Class III devices or equivalent combination of education and experience
Patent Agent
We are looking for a Patent Agent to develop, write, and edit patent applications and patent office responses
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.
In the fields of chemistry and materials sciences:
•Reviews invention disclosures, engineering notebook entries, product specifications, patents, journals, papers, and other technical documents;
•Observes research production, developmental, and experimental activities;
•Interviews production and engineering personnel to determine technical details of an invention; and
•Organizes material and completes patent specification writing assignments in a clear and concise manner according to patent office rules and standards.
•Analyzes and respond to patent office actions for related patent applications
EDUCATION and/or EXPERIENCE
Bachelor’s degree (BS) or equivalent in chemistry or materials sciences; or 2-5 years related experience and/or training; or equivalent combination of education and experience. Patent experience, and patent agent registration is very helpful.
LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and technical descriptions journals and papers in the fields of chemistry and materials science.
Second
Sight is an equal opportunity employer.
|
|