medical writer
Title posted on Jobillico -
Principal Medical Writer (Early Phase)
Posted on
December 14, 2024
by
Employer details
Syneos Health
Job details
<div> <p><b>Description</b> </p> <p><strong>Principal Medical Writer</strong></p> <p>Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.</p> <p>Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.</p> <p>Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you?ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.</p> <p>Discover what our 29,000 employees, across 110 countries already know: <br><strong>WORK HERE MATTERS EVERYWHERE</strong></p> <p><strong>Why Syneos Health</strong></p> <ul> <li>We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.</li> <li>We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. </li> <li>We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we?re able to create a place where everyone feels like they belong.</li> </ul> <p><strong>Job responsibilities</strong></p> <ul> <li><span>Mentors and leads less experienced medical writers on complex projects, as necessary.</span></li> <li><span>Represents the Medical Writing department on clinical study teams, at conferences, meetings and for presentations to the client regarding a writing project.</span></li> <li><span>Advises clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met, and quality standards are maintained.</span></li> <li><span>Develops good working relationships with internal and external colleagues.</span></li> <li><span>Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. </span></li> <li><span>Develops or supports a variety of documents that include but not limited to:</span></li> </ul> <p><span><span>o<span> </span></span></span><span><span>Clinical study protocols and clinical protocols amendments.</span></span></p> <p><span><span><span>o<span> </span></span></span><span>Clinical study reports.</span></span></p> <p><span><span><span>o<span> </span></span></span><span>Patient narratives.</span></span></p> <p><span><span><span>o<span> </span></span></span><span>Clinical development plans.</span></span></p> <p><span><span><span>o<span> </span></span></span><span>IND submissions and annual reports;</span></span></p> <p><span><span><span>o<span> </span></span></span><span>Integrated summary reports;</span></span></p> <p><span><span><span>o<span> </span></span></span><span>NDA and (e)CTD submissions;</span></span></p> <p><span><span><span>o<span> </span></span></span></span><span><span>Investigator brochures, as well as;</span></span></p> <p><span><span>o<span> </span></span></span><span><span>Clinical journal manuscripts, clinical journal abstracts, and client presentations.</span></span></p> <ul> <li><span>Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.</span></li> <li><span>Serves as peer reviewer providing review comm
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LocationQuébec, QC
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Workplace information
On site
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SalaryNot available
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Starts as soon as possible
- vacancies
1 vacancy
- Source
Jobillico
#14839828
Advertised until
2025-01-12
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