Regulatory Publishing Specialist (ARG & Serbia Only)

Regulatory Publishing Specialist (ARG & Serbia Only)

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

-Must be located in Argentina or Serbia with no sponsorship needs to be considered for this role.

Under limited supervision, will support filtering, cleaning, migration, analysis, reporting and publication of regulatory data and information, undertaken according to defined processes and operating procedures, which will be subject to internal and external audit.

Under limited supervision and with minimal guidance from more senior service line colleagues:

• Performs Assembler tasks within the document publishing system, including, but not limited to, creating publications, modifying outline, assigning and transforming documents, and adding cross references, compliance checking, Hyper-linking, bookmarking, rendering multiple documents to PDF, creation of external links, completion of Modules 1-5 in eCTD format, compilation of NeeS, compilation of paper submission, publishing and validation.
• Performs publishing tasks within the electronic publishing system, including, but not limited to, adding special sheets, applying rules, preparing for publishing, and publishing.
• Performs QC tasks within the electronic publishing system and QC of the published output, including internal QC and QC of client documentation.
• Creates, keys, and assembles client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat and others).
• Takes lead role in preparing full application submission builds.
• Troubleshoots issues with eCTD builds and provide guidance to the entry level publishers.
• Provides assistance and guidance to entry-level publishers.
• Reviews documents for legibility, completeness, and accuracy.
• Logs and tracks regulatory documents, publications, and other relevant materials.
• Organizes and compiles regulatory documentation, perform pagination, clean-up, and duplication tasks.
• May receive and deliver client information/documents, with limited supervision.
• Provides alternatives for completing assigned tasks.
• Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.
• Able to prioritize and multi-task a number of projects.

Qualification Requirements

• Moderate experience in a regulatory environment with preference given to drug/device/biologic-related industry, and experience with electronic publishing of regulatory submissions preferred.
• Good working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel.
• Experience with relevant software such as Extedo’s eCTDManager and eSUBmanager, CoreDossier, ISI Toolbox, ISI Publisher, eCTDXpress, eValidator, Acrobat, Documentum, , Ezsubs, IMS Word for Windows, and Access. 
• Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred.  Knowledge of submission requirements of various markets such as USFDA, EMA etc. an advantage.
• Good communication, organizational, and interpersonal skills.
• Ability to work independently and to understand and carry out detailed instruction.
• Attentive to the detail and accuracy of information. 
• Ability to work concurrently on several projects, each with specific instructions that may differ from project to project.

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.