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Medical Writer - Preclinical Pharmacology


  • Tech Observer
  • 11/17/18
  • Cambridge, MA
  • 02138
  • Very Competitive / Yearly
  • Contractor
Long-term W2 contract with direct pharma client based in Cambridge, MA - Massachusetts - willing to consider remote workers - ideal would be someone working onsite to train others

Summary:
Assisting team to write Clinical and preclinical pharmacology sections of 3 documents
Briefing document for the Phase III trial in relapsed refractory multiple myeloma
Writing of the supporting document and data clinical sections
Writing of the supporting document and data for preclinical and clinical sections
Briefing document for protocol assistance (non-similarity report)
Writing of the supporting document and data for preclinical Pharmacology sections
Prepare draft(s) of the document as agreed with the Sponsor, assisting team to write and format both clinical and preclinical pharmacology documents to support regulatory submissions following ICH and Sponsor guidelines and templates, with a final version provided in electronic format.
QC the document against source documents.
Check for consistency with other documents and guidelines provided for reference.
Medical Writer will use documented version control, QC, and tracking procedures to ensure that all input provided by the Sponsor is dealt with, and integrated into the document appropriately.
The MW Lead meetings and write minutes as appropriate, dispatches them to the meeting attendees and the reviewers.

Skills:
Candidates must have Medical Writing experience
Knowledge of Oncology and/or Multiple Myeloma indication is ideal.
At least 2 years experience clinical experience doing standard regulatory medical writing documents (CSRs, protocols, Investigator Brochures, IND Annual reports) including some experience with more complex documents (CTD summaries, Briefing Packages etc.)
Knowledge of ICH requirements and ability to quickly adapt to new procedures.
Experience: 3 to 6 years

Required experience:
regulatory medical writing documents (CSRs, protocols, Investigator Brochures, IND Annual reports): 2 years
clinical experience including CTD summaries, Briefing Packages etc.: 2 years
medical writing including preclinical / pre-clinical and pharmacology sections: 1 year

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