Director, Regulatory Document Quality Control

Company: Exelixis
Location: King Of Prussia
Posted on: February 20, 2025

Job Description:

SUMMARY/JOB PURPOSE: Leads a group of regulatory document quality control specialists to ensure content accuracy, consistency of information, and appropriateness of source documentation for multiple types of documents for regulatory submission. Examples include clinical and nonclinical CTD Module 2 summaries, briefing documents, protocols, investigator brochures, clinical study reports (CSRs), and other types of crossfunctional documents and reports. Requires knowledge of product areas and current developments.ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Build and maintain an effective team by recruiting, hiring, and managing appropriate scientific specialists (FTE or contractors) as needed to execute tasks related to quality control review of regulatory documents.
• Develop, plan, manage, and execute processes for quality control review of complex documents for regulatory submission according to timelines and company standards and processes.
• Ensure that data and information in complex documents are accurate, consistent with source documents, internally consistent, and meet company standards of style and quality.
• Identify and ensure the availability of regulatorycompliant source documentation that is reliable, accurate, and adequate. Recommend changes to source documents to ensure attributes meet regulatory requirements.
• Develop appropriate SOPs and work instructions and continuously improve, update, and communicate processes for quality control review.
• Negotiate adequate time for document quality control review within aggressive timelines.
• Facilitate the document quality control review process with crossfunctional teams.
• Other duties as needed.SUPERVISORY RESPONSIBILITIES:
  • Directly supervises document quality control specialists.
  • Supervises staff, including hiring, reviewing performance, and recommending salary increases, promotions, transfers, demotions, or terminations.
  • May support and direct work of contract scientific specialists.EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:
    • BS/BA degree in a life sciencerelated discipline and a minimum of thirteen years of related experience; or,
    • MS/MA degree in a life sciencerelated discipline and a minimum of eleven years of related experience; or,
    • PhD in a life science related discipline and a minimum of eight years of related experience; or,
    • Equivalent combination of education and experience.
    • May require certification in assigned area.Experience/The Ideal for Successful Entry into Job:
      • Experience in Biotech/Pharmaceutical industry required.
      • Seven to nine years of quality assurance, clinical development, or laboratory experience; or equivalent experience in the pharmaceutical industry.
      • Experience reviewing documents for regulatory submissions (e.g., INDs, NDAs, BLAs, CTDs, clinical protocols, CSRs).Knowledge/Skills:
        • Familiarity with therapeutic area of oncology is essential.
        • Knowledge of the drug development process, regulatory requirements, and general science concepts.
        • Advanced knowledge of scientific review of regulatory and clinical documents and compliance with source documents.
        • A solid understanding of clinical data analysis and reporting.
        • Proven attention to detail and ability to identify discrepancies and inaccuracies (factual, numerical, and typographical) in dense, complex documentation.
        • Ability to perform calculations to verify data with no direct source.
        • Ability to understand content of scientific literature references.
        • Ability to analyze data in biostatistical outputs.
        • Ability to manage multiple projects in fastpaced environment with challenging timelines and rapidly changing priorities.
        • Good judgment and willingness to adapt working style and work product as required while adhering to quality standards.
        • Record of collaborative multidisciplinary teamwork and problem solving; ability to help facilitate crossfunctional team agreement and complete projects.
        • Proficient in Windows suite.
        • Has good general knowledge of other related disciplines.
        • Has good timeline development and management skills.
        • Applies strong analytical and business communication skills.JOB COMPLEXITY:
          • Supervision of document quality control specialists, emphasizing collaboration, skill development, and career growth.
          • Works on significant and unique issues where analysis of situations requires an evaluation of intangibles. A high degree of independent work and strategic flair are required.
          • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
          • Uses professional concepts and company's policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
          • Networks with key contacts outside own area of expertise.WORKING CONDITIONS:
            • Environment: primarily working indoors, performing clerical work.Notice to Recruiters/Staffing AgenciesRecruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.#LI-MB1If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $196,000 - $278,000 annually. The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.DISCLAIMERThe preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

Keywords: Exelixis, Philadelphia , Director, Regulatory Document Quality Control, Executive , King Of Prussia, Pennsylvania