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Vertex Pharmaceuticals
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Vertex Pharmaceuticals
Boston, Massachusetts, United States
3 days ago

Description

Job Description

This individual would be responsible for ensuring the preparation and management of Chemistry, Manufacturing, and Controls (CMC) regulatory documents related to all pre- and post-marketing activities in all regulatory jurisdictions with a primary focus on the United States and Europe. The CMC Technical Writer works closely with contract manufacturing organizations (CMOs) as well as internal quality and regulatory affairs functions to author high quality Module 2 and 3 CMC regulatory documents for BLAs and MAAs.

Responsibilities:
  • Lead/support Project Leader in the development, writing, and editing of CMC related technical data for inclusion in Module 3 of the CTD. This will include information from SOPs, Batch Records, stability protocols, process validation reports, etc. as part of preparing INDs, BLAs and IMPD sections, related Module 2 summaries (QOS), briefing documents, and other documents needed to support regulatory meetings, marketing applications, and life cycle management documents
  • Review, prepare, manage, and lead responses to CMC related questions from Regulatory Authorities such as FDA, EMA, MHRA, Health Canada, others as required
  • Perform reviews of documents prepared by other team members for completeness, accuracy, structure, and grammar
  • Interpret and analyze quality data related to product characterization, manufacturing process, product and process control, and stability while interpreting and analyzing applicable tables, listings, and figures
  • Work closely with Regulatory Affairs, Analytical Development/QC, Quality, Process Development and Manufacturing to communicate document-specific timelines to team members to ensure on-time deliverables are completed
  • Perform other related duties and assignments as required


Requirements:
  • Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent
  • 7+ years (Bachelors), 5+ years (Masters), 3+ years (PhD) of relevant CMC experience
  • Chemistry, Manufacturing and Controls (CMC)
  • Hands-on experience with Common Technical Document (CTD) authoring
  • A background of pharmaceutical manufacturing or quality control/quality assurance
  • Experience participating in or leading regulatory submissions, BLA/MAA preparation and filing experience a plus
  • Expertise with MS Office, Word, Excel and document management systems such as Veeva


Knowledge, Skills and Abilities:
  • Excellent writing skills coupled with ability to edit complex material to ensure accuracy, clarity, consistency and effectiveness
  • Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, knowledge of cell and gene therapy products a plus
  • Thorough knowledge of biologics process development
  • Knowledge of product lifecycle - Product and process development, clinical trials, validation, and regulatory submissions
  • Working knowledge of regulatory requirements for biologics, pharmaceuticals, and/or medical devices
  • Knowledge of US and non-US pharmaceutical regulations is essential
  • Demonstrated experience working with document contributors, including analytical experts, biostatistics, manufacturing operations and regulatory affairs to ensure appropriate collaboration and input into document development
  • Previous experience with and expert knowledge of cGMP guidelines
  • Must be able to function and contribute as part of a team, have excellent interpersonal, verbal and written communication skills and contribute to team-based decisions
  • Ability to think critically, and demonstrated troubleshooting and problem-solving skills


Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.

Job Information

  • Job ID: 57997714
  • Location:
    Boston, Massachusetts, United States
  • Position Title: Temporary Regulatory CMC Technical Writer
  • Company Name: Vertex Pharmaceuticals
  • Job Function: Other / Not Listed
  • Job Type: Full-Time

At Vertex, we bring together the brightest minds in the relentless pursuit of creating transformative medicines for people with serious and life-threatening diseases. Founded in 1989 in Cambridge, Massachusetts, we are one of only a handful of biotechnology companies founded since 1976 that has discovered and developed four or more approved medicines in our own labs. In addition to the four medicines we’ve developed to treat the underlying cause of cystic fibrosis, we have ongoing research programs focused on the underlying ...

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