Position: Medical Writer
Location: New Jersey
Contract Length: 6-months +
The Role: The Medical Writer will focus on the preparation, assembly, writing, and reviewing of the documentation necessary to support Phase I-IV clinical development programs.
- Development or updating of Investigator's Brochures, Periodic and Developmental Safety Update Reports, and related regulatory documents.
- Incorporation of text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner consistent with the target audience and regulatory requirements.
- Consolidation and evaluation of review comments from colleagues to determine needed revisions
- Editorial review of documents for grammar, punctuation, and submission-compliant formatting
- As needed, preparation of or assistance with clinical study protocols and protocol amendments, clinical study reports and appendices, or other regulatory documents.
- Reliance on instructions, templates, and pre-established guidelines (eg, Standard Operating Procedures, Amicus Style Guide) will be expected to perform the above functions. Additionally, you must be able to work independently and efficiently with cross-functional team members.
- Bachelor's degree with 5-7 years experience, Master's degree with 2-5 years experience, Ph.D or Pharm.D with 1-2 years experience.
- Previous experience in the writing of clinical/regulatory documents, such as protocols, investigator brochures, safety updates, and clinical study reports
- Training in the biomedical sciences, particularly in areas such as pharmacology, biology, chemistry, and/or biotechnology
- Understanding of medical terminology and AMA style
Why Work Here?
This Pharmaceutical Corporation seeks to deliver the highest quality therapies for persons living with rare diseases and support the disease communities along with their families.
Sthree US is acting as an Employment Business in relation to this vacancy.