CMC Content Analyst

CMC Content Analyst

5-8 years
Not Specified

Job Description

Main Purpose of Job:
The content specialist is responsible for providing accurate and timely regulatory CMC intelligence information for specific countries highlighting the differences with the standard CTD format. The content specialist will have a solid experience in the industry and will be familiar with CMC requirements worldwide.
Duties and responsibilities:
  • Monitor the evolution of CMC regulatory landscape worldwide
  • Analyze the changes in the CMC requirements and implement them in the database. The content specialist must act as internal expert for a set of countries
  • Work in collaboration with a pool of external consultants.
  • Undertake the research and identification of local CMC experts, negotiation of contract terms and copyrights when needed.
  • Provide support to CMC Product Manager
  • Provide support and act as team representative for customers when required
  • Communicate relevant information to concerned stakeholders.

Knowledge, Skills, and qualification
  • Minimum BS degree in Life Sciences
  • 5 years experience on Pharmaceutical development, CMC manufacturing or CMC regulatory affairs.
  • Strong knowledge of quality aspects of drug development and ICH requirements.
  • Knowledge of Biological entities would be appreciated
  • Experience on submissions, responses to deficiency letters and communications with health authorities on quality aspects of the product is required.
  • Experience working with teams globally
  • Demonstrated ability to work collaboratively and resolve conflict across different functional areas in a highly matrixed organization.
  • Good problem solver and able to demonstrate good judgment in decision making and setting priorities.
  • Capability to work remotely with peers in an international environment
  • Team spirit, good communication skills and proactivity.
  • Fluent in English. Another European language would be appreciated.

It is the policy of Clarivate to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, pregnancy, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Clarivate will provide reasonable accommodations for qualified individuals with disabilities.

Job Details

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About Clarivate

Clarivate(tm) is a global leader in providing solutions to accelerate the lifecycle of innovation. Our bold mission is to help customers solve some of the world's most complex problems by providing actionable information and insights that reduce the time from new ideas to life-changing inventions in the areas of science and intellectual property. We help customers discover, protect and commercialize their inventions using our trusted subscription and technology-based solutions coupled with deep domain expertise. We now have more than 8,500 colleagues in over 40 countries worldwide, and we work with over 200 partners to deliver value and success for our customers. Today, Clarivate is a publicly traded company, listed on the New York Stock Exchange under the ticker NYSE:CLVT. Clarivate is committed to building, nurturing, and developing a diverse culture of belonging where new colleagues can bring their authentic self to work every day! Join us!

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