There is an announcement for the Vacancy for Medical Writer at CAMRIS International in the USA. Interested candidates can apply for the position now.

CAMRIS is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective programs and research management services. Additionally,  it combines proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Its core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

Duties

The incumbent will do the following duties

• Write, review, edit, and/or advice during the development of documents such as IND annual reports, protocols, Investigator’s Brochures, chemistry, manufacturing, and controls [CMC] information amendments, etc.
• Additionally, he/she will use Microsoft Office and Adobe software applications, PDF editing software to be able to research and review content effectively.
• Also, the candidate should interpret information into clear and concise scientific writing and apply applicable FDA regulations for the writing and publishing of regulatory submissions.
• Likewise, use project management principles to communicate effectively within the Integrated Product Team (IPT) development framework.
• Furthermore, write, review, edit multi-volume documents requiring advanced word processing and formatting, indexing. Also, the generation of the table of contents, and manual pagination according to FDA regulations.

Working Conditions

Work environment characteristics described here are representative of those that employees must meet to successfully perform the essential functions. Additionally, the company will provide reasonable accommodations to enable individuals with disabilities to perform the essential functions.

Qualifications

• Bachelors or better in Science or related field.
• Additionally, 8-10 years: experience in regulatory medical writing for pharmaceutical, biotechnology, or contract research.
• Furthermore, the understanding of FDA regulatory documentation requirements.

Visit the official page for further details.

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