Oxford Global Resources

Medical Writer

Oxford Global Resources • $114K — $149K *
Raritan, NJ 08869In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
1 month ago
Job Overview by Ladders

Qualifications

  • 5+ years in Medical Writing within Biopharmaceuticals, especially NDA support
  • Regulatory writing background preferred
  • Strong independent working ability
  • Direct management or coordination experience with external resources
  • Exceptional written and verbal communication skills
  • Proficiency in English grammar and punctuation
  • Expertise in relevant software, especially Microsoft Word

Responsibilities

  • Author or oversee clinical documents like Study Protocols and Clinical Study Reports
  • Develop and manage Regulatory Documents including CTD sections and briefing documents
  • Coordinate submissions for manuscripts and posters, ensuring robust internal and external reviews
  • Manage external medical writing teams and resources
  • Organize key Framework Meetings to align on document scope and insights
  • Ensure document reviews are conducted thoroughly and on schedule
  • Collaborate with cross-functional teams to align document timelines with project goals

Benefits

  • Opportunity to work at the forefront of drug development
  • Involvement in diverse scientific and regulatory writing tasks
  • Collaboration with multidisciplinary teams
  • Potential for career advancement in a growing field
  • Supportive environment for skill development and expertise enhancement
Full Job Description
Summary:

The purpose of this role is to write, or coordinate the preparation of, all clinical, regulatory and scientific documents intended to support clinical and regulatory deliverables for drug development project teams. The scope of the role includes authoring, review, and quality assurance check of documents, and management of external medical writers.

Project Details:
  • Author or coordinate the authoring of the following Clinical Documents: Study Protocols, Clinical Study Reports, Clinical Study Summaries (for posting to study registries)
  • Author or coordinate the authoring of the following Regulatory Documents:
  • Common Technical document (CTD) clinical and nonclinical sections for IND, NDA and MAA documents
  • Briefing Documents for Regulatory Interactions, e.g., FDA Meetings, EMA
  • Scientific Advice
  • Responses to Regulatory Agency questions Author or coordinate the authoring of the following multidisciplinary documents: Investigator Brochure
  • Orphan Drug Designation Requests
  • Manuscripts and posters, including support for primary author, writing or coordinating first drafts, managing internal and external reviews and journal submission
  • Manage external medical writing resources
  • Organize Framework Meetings prior to the initiation of key clinical or regulatory documents to ensure alignment on essential insights and scope
  • Coordinate the review and quality check of all documents
  • Work with Clinical Development, Biostatistics, Safety, Regulatory Affairs and Project Management to ensure document preparation timelines are consistent with Program goals


Job Experience:
  • Five or more years experience in Medical Writing in the Biopharmaceutical industry, with experience supporting NDA filings
  • Regulatory writing experience is preferred
  • Ability to work without close supervision
  • Direct management experience or experience coordinating external resources
  • Excellent written and verbal communication skills
  • Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
  • Ability to multi-task and complete assignments on time
  • Excellent problem-solving capabilities and organizational skills
  • Knowledge of medical, pharmaceutical, and clinical research concepts
  • A high degree of familiarity with statistical and data output
  • Expert level skills in relevant computer software including Microsoft Word, and familiarity with bibliographic citation tools and software
  • Knowledge of the methods, techniques, and procedures of medical writing tasks
  • Prior clinical protocol and CSR writing experience
  • Prior experience with documents for submissions in electronic Common Technical Document (eCTD) format.
  • Detailed and experienced-based understanding of applicable regulations, and the CTD structure.

Hourly Rate: 55-72

About Oxford Global Resources

Oxford Global Resources is a staffing and recruiting company that provides temporary and permanent staffing solutions to clients in a variety of industries. The company was founded in 1984 and is headquartered in Cambridge, Massachusetts. Oxford Global Resources offers a range of services, including contract staffing, direct hire, and temp-to-perm staffing. The company's clients include some of the world's leading companies in the biotechnology, pharmaceutical, and medical device industries, as well as government agencies and other organizations. Oxford Global Resources is committed to providing high-quality staffing solutions that meet the unique needs of each client.
Learn more about Oxford Global Resources
Size
500 employees
Industry
Staffing
Founded
1984
* Ladders Estimates

Similar Jobs

Ad banner background

Get Ready For Your
Next Interview

More Jobs at Oxford Global Resources

  • Oxford Global Resources
    L&D Sales Enablement Trainer
    $80K — $110K *
    Beverly, MA 01915 (Essex County)
    Reposted 3 days ago
    Business Services
    In-Person
  • Oxford Global Resources
    Project Controls
    $131K — $172K *
    Alma, WI 54610 (Buffalo County)
    5 days ago
    Technical Services
    In-Person
  • Oxford Global Resources
    Construction Manager
    $131K — $172K *
    Gary, IN 46404 (Lake County)
    Reposted 6 days ago
    Real Estate & Construction
    In-Person
  • Oxford Global Resources
    Mechanical Engineer
    $181K — $234K *
    San Jose, CA 95123 (Santa Clara County)
    6 days ago
    Manufacturing & Automotive
    In-Person
  • Oxford Global Resources
    Data Scientist
    $95K — $127K *
    Akron, OH 44312 (Summit County)
    6 days ago
    Information Technology
    In-Person

More Pharmaceuticals & Biotech Jobs

Find similar Medical Writer jobs:

NationwideRaritan, NJ