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Regulatory Operations Associate

Plexxikon Inc.

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Location: Berkeley, CA Posted Date: 4/18/2013 Position Type: Full time Job Code: Regulatory Operations Required Education: Bachelors Degree Areas of Expertise Desired: Regulatory Affairs

Description

Plexxikon is a leader in the discovery and development of novel, small molecule pharmaceuticals. The company has utilized its proprietary discovery platform to successfully develop a portfolio of competitively differentiated clinical and preclinical stage programs in a number of therapeutic areas. Plexxikon’s most advanced program, Zelboraf™ (vemurafenib, and formerly known as PLX4032), has recently been approved by the FDA. Plexxikon's demonstrated capability in discovery and early development uniquely positions the company to develop multiple commercial franchises for different therapeutic indications, and create significant value for Plexxikon and its collaborators.

Plexxikon's novel discovery approach, combined with an experienced management and scientific team, a broad network of scientific and clinical experts, and partnerships that support later stage development, have been key drivers of the company's success since it began operations in 2001.  In April 2011, Plexxikon became a member of the Daiichi Sankyo Group, and continues to build its broad and diverse pipeline.

Plexxikon is a small business with less than 50 employees and this position will be a critical member of the Regulatory Affairs team reporting to the Manager of Regulatory Affairs.  The Regulatory Operations Associate will manage the document control system and support creation, editing, and compilation of clinical, nonclinical, and regulatory documents for INDs, amendments, supplements, annual reports, and safety updates. This is an exceptional opportunity to gain experience in a successful biotech company.  

Responsibilities:
• Process nonclinical, clinical and regulatory documents in MS Word
• Scan, convert and format FDA-directed documents
• Perform format proofing
• Maintain various regulatory and clinical files, logs and controlled documents
• Maintain document control system for nonclinical documents
• Maintain Word document templates
• Populate and organize documents on the server
• Demonstrate continuous effort to improve operations, decrease turnaround times, streamline work processes, and work cooperatively and jointly to provide quality seamless customer service
• Other duties as assigned

Requirements

Position Requirements & Experience:
• At least 2 years experience in an administrative, legal, or regulatory role
• Experience using MS Word, Adobe Acrobat Pro, and other MS Office applications in a controlled publishing environment preferred
• Familiarity with PDF conversion and common Scanning/OCR functions
• Experience in regulatory document processing and management preferred
• High attention to detail and accuracy
• BA/BS degree in related field preferred (or relevant experience)
• Comfortable in a fast-paced small company environment with minimal direction and adjust workload based upon changing priorities
• Exceptional problem solving skills
• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment in communicating data  
• Desire to learn and tackle new challenges is imperative  

Plexxikon, an equal opportunity employer, is located in Berkeley, just off interstate 80.  We offer a chance to work with talented people in a collaborative environment and provide top-notch benefits including health insurance, generous time off and much more.   To learn more about Plexxikon, please visit our website at www.plexxikon.com.

All submissions will be evaluated and interviews will be conducted for those applicants who most strongly fit our needs. If you are not contacted for an interview, your resume will remain on file and active for available positions for a period of one year.

No Phone Calls  
No Agencies or Recruiters
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