What are the responsibilities and job description for the Medical Writing Manager - U.S./Canada/LATAM Remote position at Worldwide Clinical Trials - USA?
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.
We are Worldwide Clinical Trials, and we are a global team of over 3,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!
What a Medical Writing Manager does at Worldwide
The Medical Writing Manager is responsible for managing medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget and to written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).
What you will do
What you will bring to the role
What you will bring to the role
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
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 know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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.
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.
We are Worldwide Clinical Trials, and we are a global team of over 3,500 experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.
Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.
Why Worldwide
We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!
What a Medical Writing Manager does at Worldwide
The Medical Writing Manager is responsible for managing medical writing activities in accordance with client specifications in a timely, accurate, and efficient manner, within budget and to written, scientific, and ethical standards in accordance with regulatory requirements and WCT standard operating procedures (SOPs).
What you will do
- Manage the process anddelivery of studydocuments such as protocols,informed consent documents,clinical study reports(CSRs), patient narratives, and other study documents
- Manage the process anddelivery ofproduct documents such as investigator drug brochures, summary documents, and other documents
- Manage direct reports (internal employees or vendors), as assigned
- Perform review and QC of documents, as needed
- Advise project team and clients on medical writing-related issues
What you will bring to the role
- Expert knowledge ofmedical writing principles and application
- Excellent writtenand spokenEnglish,able to accuratelyinterpret data and express findingsin a clear and concise written manner
- Superior knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9)
What you will bring to the role
- University/college degree (life science or related allied health profession) andAmerican Medical Writers Association Certification or equivalent combination of educationand experience that provides the individual with the required knowledge, skills and abilities.
- Graduate degree preferred
- Minimum of 8 yearsofclinical pharmaceutical industry experience includingmedical writing
- Thorough knowledge ofapplicable regulatory guidelines related tomedical writing
- A demonstrated track record of success inmedical writing andmanaging vendors
- Available for domestic and internationaltravel, including overnight stays (valid passport)
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide !For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
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 know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. 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.
