PRN Senior Medical Writer
Location: Texas, United States
Requisition Number: 1435
Position Title: Senior Medical Writer
SUMMARY: The PRN Senior Medical Writer is responsible for carrying out medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget and to the written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).
Tasks may include but are not limited to:
- Prepare study documents such as protocols, informed consent documents, clinical study reports (CSRs), patient narratives, and other documents in accordance with regulatory requirements and WCT SOPs.
- Prepare product documents such as investigator drug brochures, summary documents, and others in accordance with regulatory requirements and WCT SOPs.
- Coordinate internal and client document review cycles.
- Attend project-related meetings, as needed.
- Perform review and QC of documents, as needed.
- Serve as publishing point-of-contact in conjunction with the document coordinator to publish CSRs or other documents, as needed.
- Create and manage project-specific timelines, adaptation of timing and milestones based on client needs/feedback.
- Identify and appropriately communicate risks associated with document delivery and propose mitigation plans.
- Advise project team and clients on medical writing-related issues.
- Complete project-specific and company training, as assigned.
- Perform other duties as assigned.
OTHER SKILLS AND ABILITIES:
- Excellent written and spoken English, able to accurately interpret data and express findings in a clear and concise written manner.
- Excellent project/time management and organizational skills, and ability to work independently.
- Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
- Comprehensive Microsoft Office, especially WORD but also PowerPoint and Excel skills, as well as internet skills.
- Ability to communicate with professionals from a variety of backgrounds.
- Attention to detail—style, consistency, grammar, syntax, scientific accuracy.
- Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).
- University/college degree (life science or related allied health profession) and American Medical Writers Association Certification or equivalent combination of education and experience that provides the individual with the required knowledge, skills, and abilities to perform the above responsibilities.
- Graduate degree preferred.
- Minimum of 3 years of clinical pharmaceutical industry experience including skills and competency in medical writing.
- Available for domestic and international travel, including overnight stays (valid passport)
Employment Type: PRN
Community / Marketing Title: PRN Senior Medical Writer
We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.