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    Cmc Regulatory Technical Writer Ii

    Pyramid Consulting, Inc
    5+ years
    Not Disclosed
    Bridgewater
    10 Aug. 7, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    About the Job

    Job Title: CMC Regulatory Technical Writer II

    Duration: 12+ Months Contract with long-term potential

    Location: Bridgewater, NJ - 08807, and Boston, MA 02141 (Hybrid)

    Job ID: 24-29905

    Pay Range: $45 - $50/hour. Employee benefits include health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

    Notes:

    • Open to local candidates only
    • NJ candidates: Hybrid schedule (2x week)
    • Boston candidates: In-person training, fully remote after

    Education: Minimum qualification is a Bachelor's degree in Biology or Pharmacy.

    Must-Have Experience: VEEVA, life-cycle tools, MS Suite (especially Word & Excel).

    Preferred Experience: Regulatory affairs

    Work Experience: 5 years of industry experience.

    Key Responsibilities:

    • Contribute to various US, EU, and rest of world (ROW) dossiers such as NDA, MAA, IND, IMPD, CTA, amendments, supplements, variations, and other communications with regulatory authorities (e.g., briefing documents for meetings).
    • Define and manage the compilation of documentation required for authoring by coordinating with internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global client locations, contract manufacturing organizations (CMOs), or alliance partners.
    • Identify potential regulatory risks/challenges while ensuring regulatory compliance.
    • Autonomously author the CMC sections of dossiers using client templates and source documentation in accordance with Common Technical Document (CTD) guidances and company standards.
    • Ensure timely delivery of sections.
    • Manage the writing of responses to CMC questions from Health Authorities with support from Quality, GRA, technical experts, or CMOs.
    • Perform life cycle management for marketed products by creating and/or evaluating change controls for global regulatory impact and planning corresponding variations/amendments/supplements.
    • Maintain an up-to-date knowledge of client's ways of working and SOPs, and develop a comprehensive understanding of global CMC regulations and guidelines to enhance regulatory success and compliance.
    • Author other types of regulatory documents such as white papers, position papers, and briefing books.
    • Support non-regulatory writing projects such as SOPs and technical documents throughout the department.

    Key Requirements and Technology Experience:

    • Possess Chemistry, Manufacturing, and Controls (CMC) and CTD experience.
    • Have CTD Module 3 authoring skills.
    • Pharmaceutical manufacturing or quality control/quality assurance background is a plus.
    • At least 5 years' experience in the pharmaceutical industry.
    • Expertise with MS Office, Word, Excel, and document management systems such as Veeva or Documentum.
    • Working knowledge of cGMPs is desired.
    • Experience with CMC documentation pertinent to various dosage forms and biological products is a plus.
    • Excellent interpersonal communication skills and demonstrated ability to interact within a multi-disciplinary team.
    • Able to manage priorities independently, highly organized, and self-motivated.
    • Should enjoy writing and have knowledge of US pharmaceutical regulations. Exposure to ex-US regulations is desired but not mandatory.
    • BS/BA, MS, or PhD from an accredited school in a science/health field (e.g., Biology, Analytical Chemistry, Pharmacy, or a related field).

    Our Client: A leading healthcare industry company currently interviewing to fill this and other similar contract positions. If you are interested, please apply online for immediate consideration.

    Equal Employment Opportunity:

    Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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