Sr. RA Project Specialist

Brief Description of the Position:Support Regulatory Affairs (RA) departmental processes through expertise with electronic systems and technologies used by RA and facilitation of site-wide communication

The RA Project specialist will be responsible for facilitation of RA staff to utilize in a routine manner electronic tools and technologies for regulatory activities worldwide

The RA Project Specialist will provide specific solutions and plans related to technical logistics for electronic systems (i.e., eCTD/eINDs between RA Publishing and external SMEs). For example, what technology is needed for documents prepared by SMEs or authors, which systems need to be utilized, by whom and by when

Provide technical expertise of IMR (BRAIN) application used by RA.

Understand and provide general use assistance of Documentum applications used by RA (e.g., ESPS, EDMS, TOPAS, PharmDoss, GRAiL, etc.)

This assistance will be provided in a way that engages RA staff to become more comfortable with the use of multiple tools.

Develop and maintain RA intranet website

Implement and maintain the RA intranet website in order to communicate departmental activities, Regulatory guidance and resources (e.g., Library, Pink Sheet, IDRAC etc.) to the Berkeley Site

Maintain and develop Regulatory Procedures (e.g., SOPs) and coordinate internal trainings



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Note: Additional duties may be assigned or positions may be transferred between functions or projects to meet divisional or business requirements.

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Position Requirements for this position:

4 yrs BSc./BA Degree or more advanced degree in Science or technology related field 5-7 years Pharmaceutical or biotechnology experience or regulated industry experienceKnowledge of Regulatory Affairs systems and processIncumbent must possess excellent problem solving skills, verbal and written communication???????????? skills and presentation skills.Excellent interpersonal skillsResults and detail orientedCommand of HMTL, XML, and principles of website design desiredWorking knowledge of 21 CFR Part 11 and other related GXPsAdvanced knowledge of MS Office SuiteDemonstrated expertise of database systems and applications (e.g., Documentum v5.1 or higher, Regulatory Submission tracking, Access)Proficient in SOP writingAbility to work independently and with teamsExperience managing staff