Sr Publishing Specialist Job Vacancy in Syneos Health Clinical Bengaluru, Karnataka – Latest Jobs in Bengaluru, Karnataka

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Company Name : Syneos Health Clinical
Location : Bengaluru, Karnataka
Position : Sr Publishing Specialist

Job Description : Sr Publishing Specialist – (22003026)

Description
Senior Publishing Specialist
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.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.
Job responsibilities
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.

Qualifications
What we’re looking for
BA/BS with preference given to a science degree.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
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.

Primary Location: Asia Pacific – IND-Home-Based (Bangalore)
Other Locations: Asia Pacific – IND-Gurugram-Cyber-City, Asia Pacific – IND-Home-Based
Job: Regulatory Affairs
Schedule: Full-time
Travel: No
Employee Status: Regular

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