Senior Medical Writer - US/Canada - Home-based
Multiple Locations: Austin, TX, USA • Canada • United States
Requisition Number: 5478
Position Title: Senior Medical Writer
Who we are?
We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.
What is Medical Writing at Worldwide?
- Dynamic global team with comprehensive peer, leadership and administrative support
- Multi-levelled team, with ongoing training and opportunities for career development
- Writing a wide range of documents across many therapeutic areas
- Liaising with Subject Matter Experts across Worldwide including regulatory strategists and clinical methodologists in high level protocol and clinical development discussions
What you will do?
- Write study documents such as protocols, informed consent documents (ICF, investigator brochures (IB), clinical study reports (CSRs), and other documents in accordance with regulatory requirements and WCT SOPs.
- Carry out medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, and to the written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).
- Coordinate internal and client document review cycles. Attend project-related meetings, as needed. Advise project team and clients on medical writing-related issues.
- Create and manage project-specific timelines, adaptation of timing and milestones based on client needs/feedback.
What you will bring to the role?
- Proven experience in writing regulatory documents incl. but not limited to CSRs, protocols, IB, ICF
- Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.
- Project/time management and organizational skills, and ability to work independently and as part of a team
- Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9)
- Ability to communicate with professionals from a variety of backgrounds. Attention to detail—style, consistency, grammar, syntax, scientific accuracy
- Excellent written and spoken English and competency in Microsoft Office
- Minimum of 2 years’ experience of medical writing in the clinical pharmaceutical industry, preferably in a clinical research organization
- Degree in life science or other applicable area, or equivalent combination of education and experience
At Worldwide, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient’s life depends on it – because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.
Employment Type: Regular
Community / Marketing Title: Senior Medical Writer - US/Canada - Home-based
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.
Location_formattedLocationLong: Austin, Texas US
CountryEEOText_Description: Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law. Worldwide is committed to working with and providing reasonable accommodations to applicants with disabilities. We are proud to be an equal opportunity workplace where people thrive by being themselves and are inspired to do their best work every day.