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Job

Associate Director, Regulatory Operations

  • Location

    San Francisco

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    $130,000- $150,000

  • Contact:

    Marissa Saunders

  • Contact email:

    m.saunders@hamlynwilliams.com

  • Salary high:

    0

  • Salary low:

    0

  • Published:

    about 2 months ago

  • Expiry date:

    2020-03-04

A Pharmaceutical client of ours is looking for an Associate Director of Regulatory Operations to aid in all clinical and regulatory documentation. This position can be either on site or remote depending on residence. 

Responsibilities

  • Edit and format all documents to meet the clinical and regulatory needs for electronic submission and agency review
  • Provide technical QC review of clinical/ regulatory documents to ensure proper formatting, accuracy, and consistency
  • Collaborate with colleagues and develop timelines for all clinical and regulatory documents
  • Perform "pre-publishing" of documents to ensure that they are ready for publishing and submission
  • Maintain standards for styles and formatting of all clinical documents 
  • Assist in training and support of employees and external contractors using company document templates and authoring 

Requirements

  • BA/BS in English or relevant scientific area
  • 8 years of experience or more in document production for the pharmaceutical industry

Preferred Qualifications

  • Knowledge of US and EU regulatory requirements for document submissions
  • Great attention to detail 
  • Comfortable in a fast paced environment being adaptable
  • eCTD experience

This role is actively interviewing, so if interested please feel free to contact Marissa at m.saunders@hamlynwilliams.com