Get Clinical Research JobsGet Clinical Research Jobs

Medical Writer - Preclinical Pharmacology


Ad
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

Please leave blank
Minimum of 400 (0) characters
Please leave blank
Good news! We have your resume on file, you can use our Quick Apply function to easily apply to this job.

Critical Need Jobs


Employer Information

Previous Page New Search

I appreciate having the opportunity to review the current Pharmaceutical industry positions at the Director of Clinical Research level. There is always at least one position of great interest.

Larry Hofmann, Medical Monitor

Join 3,412 other Clinical Research Professionals receiving FREE weekly job listings to their inbox every week.

We value your privacy. We will not rent your email to anyone.

Browse other Clinical Research Jobs in Massachusetts

  1. Senior Research Scientist - Machine Learning for...

    Cambridge, MA
    Job Title Senior Research Scientist - Machine Learning for Healthcare Job Description In this...
  2. Orthopedic Surgeon

    Cambridge, MA
    . Our surgeons excel in clinical, research, operational, academic and health administration arenas...
  3. Internal Medicine Physician

    Cambridge, MA
    physicians excel in the clinical, research, operational, academic and health administration arenas. Many...
  4. Clinical Research Associate (CRA)

    Cambridge, MA
    Job Description Clinical Research Associate (CRA) Oncology is required (Ideally 7+ years) 11 month...
  5. Clinical Research Scientist

    Newton, MA
    within the assigned clinical development team. The Clinical Research Scientist (CRS) works closely with...
  6. Clinical Research Scientist Immuno-Oncology

    Billerica, MA
    Job Description A career with EMD Serono is an ongoing journey of discovery: our 52,000 people are...
  7. Senior Research Scientist - Machine Learning for...

    Cambridge, MA
    Job Title Senior Research Scientist - Machine Learning for Healthcare Job Description In this...
  8. Clinical Research Scientist - perm/direct hire...

    Lexington, MA
    Job Description Title of Position: Clinical Research Scientist (can be Associate Director...
  9. Research Scientist

    Cambridge, MA
    for cell-based drug delivery. We are seeking a Ph.D. level research scientist to function as a...
  10. Research Scientist - Cell Biology

    Cambridge, MA
    Job Description Research Scientist - Cell Biology We are seeking a skilled and motivated scientist...
Browse all Clinical Research Jobs in Massachusetts
Previous Page New Search