Proclinical is currently recruiting for a Regulatory Writer for a gene therapy program located in Philadelphia, PA.
- Support the development of various scientific and regulatory documents necessary for the submission of IND applications.
- Oversee all report writing activities for the projects you are supporting.
- Ensure consistency across documents and improve overall document quality.
- Provide the appropriate background information, guidance, and training to any writer producing documents to support their tasks.
- Prepare and/or review all final documents (i.e., study reports/protocols/ Investigator Brochures/IND submission elements, etc.).
Skills and Requirements:
- PhD or PharmD preferred, Masters degree in Life Sciences, Writing or related field and 3 to 5 years of medical/scientific writing experience (or equivalent combination of education and experience
- Thorough understanding of the applicable Title 21 Code of Federal Regulations and ICH guidelines
- Superior writing skills with strong attention to detail a must!
- eCTD experience strongly preferred.
- Ability to analyze and interpret complex data from a broad range of scientific disciplines.
- Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team.
- Understanding of documentation requirements related to IND submissions
- Ability to mentor and train others.
- Superior computer skills, including high-level word processing and graphic presentations.
- Experience with Microsoft Office including PowerPoint.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sarah Beshara at (+1) 267-477-3355 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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