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Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
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 deliver - for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
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 building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

The Document Specialist is responsible for providing document management, formatting, and publishing services to support the creation of electronically compliant documents for global regulatory submissions and transparency requirements. This role provides expertise and guidance on regulatory document standards and electronic publishing requirements to ensure submission-ready content that meets health authority and industry specifications, including those of the FDA, EMA, and other global regulatory agencies.

The Document Specialist collaborates closely with cross-functional teams to prepare, format, review, and publish regulatory submission documents, scientific reports, and external publications. The role is actively involved in document production activities, ensuring consistency, quality, compliance, and adherence to established templates, style guides, and regulatory standards.

Key responsibilities include supporting the preparation and publication of regulatory submission content, applying electronic document compliance requirements, managing document quality control processes, resolving formatting and technical issues, and contributing to the continuous improvement of document production workflows and best practices.

The successful candidate will possess strong attention to detail, excellent organizational skills, and a thorough understanding of electronic document publishing principles, regulatory submission requirements, and document lifecycle management within a regulated environment.

Primary Responsibilities:

Provide support and guidance for the Document Finalization Team.

• Provide guidance and training for other team members.
• Assist management with assigning and prioritizing publishing projects and tasks.
• Anticipate and resolve key technical and operational problems.
• Respond to and/or anticipate customer needs and handle non-standard requests.
• Contribute to and/or implement SOPs or work instructions to ensure regulatory documents and systems are well controlled and comply with applicable regulations.
• Influence management on key decisions impacting the team.
• Represent as subject matter expert in cross functional projects/initiatives.

Perform document finalization/publishing services, including:

• Function as subject matter expert in document finalization/publishing.
• Produce final eCTD-compliant PDFs of medical regulatory documents using publishing software.
• Review and format Word files to ensure as many compliance requirements are in the source file as possible
• Render the Word files into PDFs. Perform bookmarking and hyperlinking as needed.
• Review the PDFs and edit them as needed to ensure that all regulatory requirements are met.
• Perform peer review of documents published by other colleagues.

Perform other document tasks as needed:

• Formatting documents to meet style/template requirements
• Uploading and/or retrieving documents from document management databases to meet customer needs
• Delivering new document types as internal and external environment changes
• Editing / Quality reviews

Partner effectively with other document delivery areas to ensure smooth delivery of final documents.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

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 Syneos Health.

http://www.syneoshealth.com

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 Job Description. 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.