Search for More Jobs
Forward job to a friend
Apply without Registering
Apply by creating/using an account
Please enter your registered email address, and we'll email you a link to reset your password right away.
Job Title: Technical Support Specialist - I
Work Location: Foster City, CA
Length of Assignment: 6 Months
Position Type: Contract Full Time
Client: A Big Pharmaceutical Company
Summary of Responsibilities
As a member of the Regulatory Information Systems team (RIS), contribute to the support, and administration of the Regulatory Affairs software platforms, applications, and tools. Provide expertise in electronic information management and submission tools and strategies to assist other members of Regulatory Affairs and Regulatory Operations during submission preparation and delivery. Participate in Tier 1 and support Tier 2 system activities. Work across functional areas, primarily with IT counterparts, to ensure the needs of the Regulatory Affairs department are met. Work across geographic regions to provide support in conjunction with other members of RIS. May serve as a resource within the team on system validation testing development and execution deliverables.
• May identify basic issues and proactively engage senior associates for resolution.
• Maintains and responds to user issues reported through the IT ticket tracking system.
• Serves as a system Business Administrator (privileged user), assists with submission development and maintenance, as needed.
• Participates on the platform Core Team.
• Troubleshoots existing practices and tools to solve day to day problems as they arise.
• Works closely with the training team within RIS to provide analysis and documentation support for training, as needed.
• Supports and delivers any systems training as needed.
• Remains knowledgeable of industry trends, changes to regulations and guidances as they pertain to submission activities.
• Maintains a proficiency and expertise with the tools and processes associated with regulatory submissions.
• Participates in both group and cross-functional process improvement and development initiatives
Regulatory Operations experience preferred, optimally within both a start-up/small biotech company and a large pharmaceutical/healthcare company, with direct experience in system implementation and support.
Familiarity with global Regulatory submissions, pharmaceutical development, and document management a plus.
Strong computer skill set and working knowledge of electronic submission requirements.
1-2 years of experience in SharePoint administration and NTFS is preferred.
A basic knowledge of computer system validation a plus.
Must have a working knowledge of Word, Word templates, Adobe Acrobat and standard Office tools.
Must be able to prioritize and balance multiple tasks simultaneously to achieve goals and satisfy customers.
Must be able to work effectively within an environment that has quickly changing processes, priorities, and deadlines.
Strong trouble-shooting\problem analysis skills.
Strong interpersonal skills, including teamwork, facilitation, and negotiation.
Experience working with cross-functional teams a plus.
Strong verbal and written communication skills and the ability to describe and present information.
Must be able to master new software and technical skills and apply them to projects as the industry, and the company evolves.
Requires a BA or BS degree in a scientific discipline or equivalent, with a minimum of 1 year of related experience preferred.
If you are interested in this job than please send me your most updated resume on email@example.com or you can reach me at #973-507-7579
Apply by creating/using an account