Job Description

Updated: Yesterday
Location: Canada-North America - CAN-Home-Based, Canada
Job ID: 23002811-CAN975

Description

Senior Document Management Specialist

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

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.

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.

Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

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.

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.

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.

We have an opportunity for a Senior Document Management Specialist to join our team, working with our Medical Writers. This role independently manages the team document management system, and is responsible for submission-ready formatting.

Job responsibilities

• Independently partners with the team with regards to document structure and assembly and document publishing of protocol and submission documents
• Provide training and troubleshooting assistance to team personnel using the document management system, and regarding submission readiness formatting and publishing work processes
• Collaborate with cross-function business partners providing direction in document formatting and publishing of protocol and other supported document types.
• Lead cross functional business partners in defining submission-ready requirements for externally authored regulatory documents. Independently manage submission readiness remediation, system import and publishing of externally authored Word and PDF files.
• Independently manage the end to end process for protocol administrative letters including structure assembly, ensuring submission readiness, and approval of document and structure.
• Contribute to team model document updates and system approval processes.

Qualifications

What we\'re looking for

• Bachelor of Science or Bachelor of Arts degree with relevant work experience.
• In-depth understanding of a document management system for assembly and management of regulatory documents.
• Understanding of document publishing processes across document types
• Expert proficiency in Word including Word template macros.
• Ability to manage timelines and quality of work using strong organizational, communication, facilitation, and interpersonal skills .
• Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization.

Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you\'ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about

Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the . The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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