Manager CMC Technical Writing

Boston, MA
Manager, CMC Regulatory 2031350
Location: Boston, MA (Hybrid/ Remote)
Science: Small Molecule Therapeutics
Job Overview: Author and manage process for CMC regulatory documents including module 3 CMC submissions, technical reports and SOPs.

Primary Job Responsibilities:
  • Author and edit CMC sections of regulatory filings for small molecule compounds in clinical development stages including IND/IMPDs, supplements and amendments
  • Collaborate with technical subject matter experts including analytical, drug substance and drug product development to review, interpret data and author technical reports
  • Manage and contribute to responses on CMC queries
  • Summarize scientific information from development reports and identify details relevant to support regulatory submissions

Primary Job Requirements:
  • BS or MS in chemistry, pharmaceutical science or a related field
  • 5+ years working in the pharmaceutical industry, and strong experience writing CMC regulatory sections (including IND’s/ CTA’s)
  • Experienced with eCTD structure and subsections
About Stratacuity:

Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

 

 

 

 

 

 

 

 

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.

Employee Type:
FullTime

Location:
Boston, MA

Job Type:
Strata: TechOps.

Date Posted:
May 31, 2024

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