-
ID
#8332515 -
Job type
Permanent -
Salary
$DOE -
Source
Pantar Solutions, Inc. -
Date
2021-01-11 -
Deadline
2021-03-12
Sr. Medical Writer/Consultant
Massachusetts, Cambridge, 02163 Cambridge USAPermanent
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.
- 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.
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