Remote CMC Writer

Beacon

Boston Massachusetts

United States

Advertising / Marketing / Public Relations
(No Timezone Provided)

Job Summary

Beacon Hill Pharma is currently hiring a CMC Writer for a REMOTE opportunity!


This individual will 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.



ACCOUNTABILITIES:



  • 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



  • REQUIRED EXPERIENCES TO APPLY FOR POSITION:



  • Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent

  • 3+ years 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



  • Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.




    Company Profile:

    Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

    Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.

    Remote CMC Writer

    Beacon

    Boston Massachusetts

    United States

    Advertising / Marketing / Public Relations

    (No Timezone Provided)

    Job Summary

    Beacon Hill Pharma is currently hiring a CMC Writer for a REMOTE opportunity!


    This individual will 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.



    ACCOUNTABILITIES:



  • 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



  • REQUIRED EXPERIENCES TO APPLY FOR POSITION:



  • Bachelor's, Master's Degree, or PhD in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, Biology, Biochemistry or equivalent

  • 3+ years 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



  • Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.




    Company Profile:

    Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.

    Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.