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  • ID
    #8332515
  • Job type
    Permanent
  • Salary
    $DOE
  • Source
    Pantar Solutions, Inc.
  • Date
    2021-01-11
  • Deadline
    2021-03-12
 
Permanent

Vacancy expired!

Job Title: Sr. Medical Writer/Consultant Location: Cambridge, MA Duration: Long Term Duties:

  • This Job Description is applicable to both the Senior Medical Writer and the Senior Medical Writer Consultant.
  • For the sake of this job description, these 2 position titles are interchangeable, and for the sake of readability, the following text will refer to the role as Senior Medical Writer.
  • The Senior Medical Writer is responsible for producing medical writing deliverables that support the clinical oncology portfolio at SDP Oncology.
  • The Senior Medical Writer will prepare clinical study documents (eg, clinical study protocols/amendments, clinical study reports, investigator's brochure), as well as clinical sections of regulatory submissions.
  • As a key member of the Clinical Study Team, the Senior Medical Writer will have the opportunity to collaborate cross-functionally and ensure key messages are consistently aligned in the preparation of clinical regulatory documents.
Key Responsibilities:
  • Draft, edit, format, and finalize clinical regulatory documents including, but not limited to: clinical protocols and amendments, investigator's brochures (IBs), and clinical study reports (CSRs).
  • Provide quality control (QC) review of clinical regulatory documents, as appropriate.
  • Produce high quality and on-time writing deliverables to support the activities and goals of the clinical study team(s), clinical program, and the Medical Writing function.
  • Ensure a consistent style of presentation of clinical documents to maintain quality and ease of review, and adherence to company standards.
  • Facilitate efficient review and finalization process of documents produced internally and externally by contractors and vendors.
  • Assist in the development of templates and standard operating procedures (SOPs). Represent Medical Writing on one or more program teams
  • Participate in Medical Writing initiatives, and process improvement, as appropriate
  • Oncology experience preferred
  • A minimum of 5 years medical writing experience in the biopharmaceutical industry with in-depth knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process.
  • Strong written and verbal communication skills, including fluency in oral and written English, with the ability to clearly present clinical data.
  • Regulatory submissions and knowledge of eCTD formatting preferred.
If You are interested, Please share your Updated Resume to or can call me on .

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