Associate Director, Nonclinical Regulatory Writing

Position Summary

Cardinal Health Regulatory Sciences (CHRS) is a consultancy organization that specializes in regulatory affairs related to drug, device, and biologic product development in the pharmaceutical industry. For 45 years, our industry-trained CMC, nonclinical, clinical, and regulatory consultants have provided expertise and guidance that has enabled pharmaceutical, biotechnology, and medical device companies achieve marketing approval of products. Our mission is in part to design and execute regulatory and product development strategies that reduce the risk of failure and increase financial returns on research investments by pharmaceutical companies worldwide. We provide effective scientific and regulatory consulting services throughout the full product lifecycle.  We are growing and looking for talented nonclinical regulatory writers to help increase our global presence and lead our clients in achieving product development and marketing approval milestones.

The Associate Director, Nonclinical Regulatory Writing will support multiple programs. Key contributions of this role include preparation of nonclinical regulatory documents, interacting with project teams and leading the development and preparation of documents through finalization.  Interacting with cross-functional teams as needed to obtain information necessary for nonclinical document development.

Position Accountabilities

What is expected of you and others at this level as a Associate Director, Nonclinical Regulatory Writing:

  • Work independently or as a part of a team to compile, write, and edit regulatory documents and reports, including writing of Nonclinical documents including Module 2.4 and 2.6 eCTD submission documents for INDs, NDA, BLAs, MAAs, Investigator’s Brochure, Meeting Requests, Meeting Information Packages, Nonclinical Study Reports, gap analyses, responses to regulatory questions regarding nonclinical, across multiple therapeutic areas.
  • Strong understanding of regulatory guidances as it applies to nonclinical submissions
  • Lead project activities independently with minimal oversight
  • Interpret nonclinical data, analyze published literature, define problems, interpret data, draw valid scientific conclusions, and propose solutions or corrective actions.
  • Manage and direct a wide variety of client project teams involving aspects of medical writing, including identifying, directing, and delegating tasks necessary for successful regulatory document completion.
  • Interact directly with clients and contractors; participate in and leading discussions during meetings/teleconferences.
  • Collaborate with cross-functional teams to respond to heath authority questions and requests.
  • Work with colleagues, clients, physicians, scientists, and statisticians in a professional and organized manner to complete projects in a timely manner.
  • Direct, assist, and train other nonclinical writers in the writing, editing, and compilation of documents that are components of clinical/regulatory marketing approval applications for new and approved drugs, biologics, or devices.
  • Prepare and manage project plans and timelines.
  • Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed.
  • Organize/prioritize work with limited guidance and manage projects in a timely and effective manner, work on multiple projects simultaneously, and reorganize and reschedule work as needed in order to meet client deadlines.
  • Understand and support the nature of our business and our company’s commitment to quality and responsiveness.
  • Proactively develop/maintain technical knowledge, remain up-to-date on current trends and best practices; leverage expertise to produce solutions that enable global consistency and standardization to ensure exceptional performance.

Qualifications

  • PhD, MS, BS in a relevant scientific discipline preferred
  • 8 years' experience in pharmaceutical industry, with 2 years' experience in nonclinical regulatory writing/editing.
  • Strong understanding of drug development, nonclinical and clinical study design, regulations (CFR, FDA, and ICH guidances, EU requirements), and scientific principles (e.g., experimental design). Understanding of medical terminology and statistical methodology preferred.
  • Experience writing nonclinical regulatory documents.
  • Excellent writing, presentation, and project management skills.  
  • Understanding of model documents (templates) and how to use them correctly.
  • Demonstrated leadership capability. Good team player characteristics.  Excellent communication and interpersonal skills.  Strong project management skills.  Organized and self-motivated. Strong attention to detail.
  • This is a remote work from home position

A Covid-19 vaccination is required in order to be employed in this position. This includes either:

  • 2 doses of the Moderna or Pfizer vaccine
  • 1 dose of the Johnson & Johnson vaccine

The Colorado Department of Labor requires all employers to provide the following information for all positions that could be performed in the state of Colorado

Anticipated salary range: $98,000-$158,300

Bonus eligible: Yes

Benefits: Health insurance, 401k Contributions, Paid Time Off, Vacation, STD/LTD 

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Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.