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Job

Associate Director Regulatory Operations (Clinical Documentation)

  • Location

    Palo Alto

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    Competitive

  • Contact:

    Bobby DeMarco

  • Contact email:

    b.demarco@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Job ref:

    BD - 20

  • Published:

    18 days ago

  • Expiry date:

    2020-07-26

  • Startdate:

    ASAP

Associate Director Clinical Documentation

Location: Palo Alto, CA

Type: Full Time Permanent

Salary: Excellent salary, bonus and accompanying benefits package

Exciting opportunity with a commercialized pharmaceutical company with a strong clinical pipeline looking to revolutionize maetabolic/oncology treatment.

Competitive Pay ~ Excellent Bonus Structure ~ Full Product Portfolio ~ Great Benefits

The Regulatory Operations Associate Director will be assisting in the leading and ensuring the compilation of regulatory submission documentation into the eCTD dossier as well the readiness for inspection by regulatory agencies. This person will be editing and formating clinical/regulatory documents to meet regulatory technical requirements and allow electronic submission and Agency review.

RESPONSIBILITIES:

  • Collaborates with colleagues to efficiently produce high-quality, strategically aligned clinical/regulatory documents supporting the regulatory requirements of a clinical development program
  • Process and publish eCTD documents for proper submission
  • Development, management, and oversight of SOPs
  • Lead the establishment and maintenance of a global Regulatory Information Management systems and database
  • Review the QC of submissions documentation

EDUCATION/EXPERIENCE:

  • BA/BS or equivalent experience, advanced degree preferred
  • At least 6 years with demonstrated experience in clinical-document production and experience in document production in the pharmaceutical industry,
  • Experience with filing eINDs

SKILLS:

  • Must have a hands-on approach and a willingness to take on projects
  • Understanding of eCTD, electronic publishing systems for preparing a regulatory submission
  • Strategic thinker with the ability to thrive in a collaborative, fast paced environment
  • Working knowledge of the drug development process
  • Demonstrate ability to work effectively in a cross functional manor while applying regulatory compliance knowledge
  • Proven communication skills (written/verbal) and organizational skills in regard to prioritizing tasks in a deadline-oriented environment

I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Bobby DeMarco at 646-349-4344