Current Open Positions

Position:  Sr. Manager/Associate Director, Regulatory Affairs

Fremont, CA

The Sr. Manager/ Associate Director of Regulatory Affairs is responsible for the development and implementation of sound regulatory strategies and direction for assigned Quark Project Teams under the leadership of the Senior Director of Regulatory Affairs and Quality Assurance. S/he must have a comprehensive understanding of FDA/EU/ICH requirements, principles, concepts, industry practices, and standards. In this hands-on role, s/he coordinates, reviews and edits the preparation of regulatory documents. Duties include preparing, reviewing, and editing of clinical trial applications (CTAs), investigational new drug applications (INDs), and key documents associated with these applications as appropriate and in compliance with national and international regulations and laws (e.g. Annual updates, Investigator’s Brochure, labeling). The position provides the opportunity to provide input into a wide variety of drug development aspects associated with Regulatory Affairs.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Represents Regulatory Affairs in project teams to develop product registration strategies and development plans aimed at achieving product application approvals.
• Provide expert guidance to project teams on regulatory mechanisms to optimize product development.
• Analyze changing regulatory requirements, evaluate risk, and establish contingency plans to assure timely submissions.
• Develop and maintain effective working relationships with multiple international regulatory agencies, as well as represent Quark at meetings with various regulatory agencies.
• Ensure that documents and regulatory submissions for domestic and international product development and registration are complete, organized, and compliant with applicable regulations.
• Provide regulatory guidance to functional areas to ensure understanding and compliance with appropriate regulations and guidelines.
• Regularly interact with senior management.
  
  
  Minimum Requirements
  
  
• Bachelor’s Degree in physical/life sciences.
• Seven or more years of Regulatory Affairs experience in the pharmaceutical or biotech industries required.
• Knowledge of drug development, product licensure, and regulatory submissions.
• Knowledgeable in ICH/cGMP/GLP/GCP, and regulatory guidelines as applied to the entire Development lifecycle of biotech and pharmaceutical companies.
• Successful experience in the preparation of INDs and CTAs.
• Knowledge of eCTD submission structure and process a plus.
• Demonstrated successful FDA interactions.
• Experience with US and international regulatory practices and procedures.
• Flexibility and willingness to multitask and change priorities in a dynamic environment.
• Strong organizational, planning, problem solving, and decision-making skills.
• Excellent written and verbal communication skills and collaborative working style.
• Desirable to have experience in renal, hepatic, transplant and/or ocular indications.
  
  

Position:

Contractor:  Sr. Clinical Data Analyst

Reports to:  Director, Clinical Data Management

Location:  Boulder, CO

Quark Pharmaceuticals is seeking an experienced professional to oversee and manage CRO data management activities for Quark sponsored studies.

       
         Primary Responsibilities:

• Provide data management expertise and support project teams for assigned projects
• Coordinate, review and approve Electronic Data Capture (EDC) systems creation, testing, release and maintenance.
• Review, approval and monitoring of data management documents and activities
• Oversee data reconciliation, database lock and final reporting.
• Coordinate sponsor team level data management issues.
•  Primary CDM liaison with CROs.
• Assist other Data Management staff with  operational tasks on other studies as appropriate.
• Perform other tasks as assigned by Director.

        Requirements

• Bachelors or Masters degree in Sciences (Biology, Computer/Statistics, etc.) Life Sciences preferred.
• Minimum 5 years of relevant data management experiences in biotech or pharmaceutical industry.
• CRO management experience or data management experience at a CRO.
• Experience with Electronic Data Capture – Medidata Rave experience preferred.
• Excellent communication skills (verbal and written).
• Ability to work independently and in team environment.
• Knowledge of FDA regulatory requirements/GCP guidance.
• Strong attention to detail.