Associate Director Chemistry Manufacturing and Controls (CMC) Technical Writing

Employer
Location
Waltham, MA
Salary
Competitive salary and benefits
Posted
Jun 02, 2018
Closes
Aug 02, 2018
Education
BS
Career Fair Category
Career Fair

Associate Director Chemistry Manufacturing and Controls (CMC) Technical Writing

There is nothing conditional about what we do.
Or who we are.
Or how we treat you.
We do what’s right.
We put science for patients first,
disrupting the model to go beyond
the concepts of conventional care.
We don’t treat a condition.
We treat people & partners.
We care to change the future.

Your Impact at TESARO:

Responsible for the strategic planning and management of CMC submission projects in alignment with business goals, to facilitate achievement of corporate objectives.

Job Responsibilities:

  • Develop and lead the execution of regulatory CMC submission. 
  • Contribute strategically and scientifically at the project and/or team level. Contribute to the definition of the CMC content requirements. Proactively identifies issues and solutions to keep to timelines.
  • Plan and manage document authoring resource needs for submission projects, and coordinate the authoring, review and approval of submission-ready documents. 
  • Interpret and summarize complex data.  Independently serve as the primary author and lead writer for of CMC documents intended for submissions to Global Health Authorities using assigned templates and style guide.

Requirements:

  • B.S. in a scientific or technical discipline with 6+ years of experience in pharma or related experience.
  • Experience with both small molecules and biologics preferred.
  • Extensive experience in the organization and format of ICH CTD M3 required.
  • Demonstrated track record in concise and precise technical writing for submissions,  aligned with the principles of ICH Q12 and Established Conditions guidance.
  • Experience writing QOS and Health Authority Query responses required.
  • Knowledge of drug development lifecycle, and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance required.

TESARO is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

FOR MORE INFORMATION, CONTACT US AT
careers2@tesarobio.com