Senior Publishing Consultant

Syneos Health, Inc.; India; Hybrid; INR 900,000 - 1,500,000; Full time

Job summary

Syneos Health is seeking a Senior Publishing Consultant to manage regulatory submissions from Gurugram/Hyderabad in a hybrid setup. You will assemble, publish and validate eCTD submissions, lead full submission builds, and provide QC across documents.

You will work with Extedo and ISI toolchains, ensure regulatory compliance, and mentor junior staff while coordinating cross-functional teams. A science background and strong communication are essential.

Qualifications

• BA/BS degree with preference for science; regulatory publishing experience preferred.
• Good working knowledge of MS Word/PowerPoint/Excel.
• Familiar with Extedo and ISI publishing tools; knowledge of US/EU submission requirements is a plus.

Responsibilities

• Assemble and publish regulatory documents for submissions.
• Lead full application submission builds and manage timelines.
• QC published output for legibility, completeness, and accuracy.
• Organize regulatory documents and perform pagination and duplication tasks.
• Prepare INDs, NDAs, ANDAs, DMFs and variations for global authorities.
• Troubleshoot eCTD builds and guide junior publishers.

Skills

Good communication

Organizational skills

Interpersonal skills

Education

BA/BS with science preference

Tools

Extedo eCTDManager

Extedo eSUBmanager

ISI Toolbox

ISI Publisher

Veeva RIM

eValidators

Acrobat

Documentum

Job description

Senior Publishing Consultant

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.

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

Job Title: Senior Publishing Consultant

Location: Gurugram/Hyderabad (Hybrid)

6+ Years Regulatory Publishing Experience | BA/BS (Science Preferred)

• 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, ISI Toolbox, ISI Publisher, eCTDXpress, eValidators, 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.
• 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.
• Receive and deliver client information/documents.
• 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

• BA/BS with preference given to a science degree and/or 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.
• Good experience with relevant software such as Extedo's eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, Veeva RIM, eValidators, Acrobat, Documentum.
• 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