Skip to content

CAREERS

Careers

Careers – Auckland, New Zealand

No Positions Currently Available

Careers – San Diego


Director, Regulatory Affairs: RA050207

Description
Proacta is a privately-held drug discovery and development company with offices in San Diego, CA and Auckland, New Zealand. The Company is developing a new generation of cancer drugs that uniquely target physiological attributes of solid tumors. Currently, Proacta is seeking a qualified candidate for the position of Director, Regulatory Affairs in San Diego, reporting to the Chief Executive Officer.

Overview
This role will oversee the global regulatory strategies and activities for drug development from candidate selection, through preclinical and clinical phases in the development, registration, and commercial marketing of the Company's products. Responsibilities include, but are not limited to:

  • Participate vigorously in defining the business, clinical and regulatory strategy for each drug candidate
  • Ensure preparation and completeness of regulatory filing from all areas (CMC, preclinical, clinical)
  • Interface with regulatory authorities in US, New Zealand, and Australia
  • Maintain current knowledge and expertise of new and revised regulations and guidelines of the regulatory environment in the US, New Zealand, and Australia, including ICH guidelines
  • Identify risk areas and develop alternative courses of action including anticipation of regulators responses through scenario planning and development of contingency plans
  • Coordinate the completion of expedited safety reports ensuring reports are complete and compliant with all applicable regulations where clinical studies are being conducted
  • Coordinate regulatory workflow, track submission timelines, and contribute to the development of complex filing systems for product development
  • Management of controlled documents
  • Provide guidance to the manufacturing and pharmaceutical development groups/vendors on regulatory requirements
  • Assist with the establishment of SOPs and revise obsolete policies as appropriate
  • Lead internal and external audits
  • Prepare reports for the Board of Directors
  • Responsible for mentoring QA/RA Associate

Requirements

  • Bachelor's degree in scientific discipline or health-related field
  • Minimum of seven years pharmaceutical experience, with five years of hands-on regulatory affairs experience; international experience is a plus
  • Regulatory Affairs Certification desirable
  • Oncology experience highly desirable
  • Evidence of active participation in the successful writing, assembly and acceptance of major regulatory submissions (INDs, NDAs) and supportive amendments or supplements
  • Previous regulatory agency interactions (e.g. pre-submission meetings, EOP2, etc.)
  • Perform job duties with minimal guidance
  • Knowledge and understanding of ICH/GCP
  • Proficient computer skills across multiple applications
  • Strong oral and written communication skills, along with good organizational and planning skills are a must
  • Ability to prioritize and multitask to ensure tasks are completed on time
  • Effectively collaborate with team members
  • Ability to deal with time demands, incomplete information or unexpected events and work effectively in a team/matrix environment
  • Must be willing to travel

Oracle Clinical Programmer, Clinical Data Management

Description
Proacta is a privately-held drug discovery and development company with offices in San Diego, CA and Auckland, New Zealand. The Company is developing a new generation of cancer drugs that uniquely target physiological attributes of solid tumors. Currently, Proacta is seeking a qualified candidate for the position of Oracle Clinical Programmer in San Diego, reporting to the Senior Manager, Clinical Data Management.

Overview
Responsible for Oracle Clinical programming needs. Will participate as an active member of a multi-disciplinary team to plan and execute clinical database tasks required for clinical trials. Responsibilities include, but are not limited to:

  • Utilizing knowledge of Oracle Clinical to develop, program, test and maintain clinical trial databases
  • Reviewing protocols and Case Report Forms (CRFs) from a database perspective
  • Maintaining timelines and troubleshooting issues that may occur during the implementation of a clinical trial database
  • Annotating CRFs
  • Creating and testing data entry screens
  • Programming and testing data validation and derivation procedures
  • Creating and maintaining the Global Library
  • Programming and generating data listings for ongoing studies
  • Performing independent database and CRF review to ensure programming consistency
  • Working with service providers to ensure that database functionality is maintained and trouble shooting any database issues that may arise.
  • Reviewing all database validation documentation
  • Interacting with external vendors concerning external data structures and updates
  • Performing and verifying external data loads
  • Lab setup, including reference ranges, panic flags, and unit conversions
  • Maintenance and upkeep of study view definitions, and study view templates including extended attributes

Requirements

  • Bachelor's degree in scientific discipline or health-related field.
  • Six or more years experience in Oracle Clinical, with at least four years spent in a database programming capacity
  • In-depth experience with Oracle Clinical database design and maintenance
  • Strong organizational and time management skills
  • Ability to interact with outside vendors on a regular basis
  • Thorough knowledge and understanding of clinical trial databases and applications.
  • Solid knowledge of ICH, GCP, CGDMP, 21 CRF 11 and their application to data management practice
  • Understands the scope of clinical trials
  • Ability to prioritize and multitask to ensure tasks are completed on time
  • Perform job duties with minimal guidance
  • Strong oral and written communication skills
  • Flexible, dependable, and able to multitask
Back to top