Regulatory Publishing Specialist

Syneos Health, Inc.; India; Hybrid; INR 600,000 - 1,000,000; Full time

Job summary

Syneos Health, Inc. seeks a Regulatory Publishing Specialist to join our Clinical Solutions team in India on a hybrid basis. The role requires 2+ years of regulatory publishing experience and a BA/BS in science, with familiarity in electronic publishing of submissions.

You will assemble and publish regulatory documents, perform QC, and prepare full submission packages using Extedo, ISI, and other tools. Collaboration with senior staff and ongoing guidance for junior publishers are included.

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.
• Experience with Extedo's eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat, Veeva, Documentum, MS Word.
• Knowledge of medical/scientific terminology, ICH guidelines and regulations and procedures preferred.
• Good communication, organizational, and interpersonal skills.
• Ability to work independently and to understand and carry out detailed instruction.

Responsibilities

• 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.
• 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.
• May create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo's eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat and others).
• Takes 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.
• May review documents for legibility, completeness, and accuracy.
• May log and track regulatory documents, publications, and other relevant materials.
• May organize and compile regulatory documentation, perform pagination, clean-up, and duplication tasks.
• May receive and deliver client information/documents, with significant supervision.
• May provide alternatives for completing assigned tasks.
• Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Independence

Education

BA/BS in science

Tools

Extedo eCTDManager

eSUBmanager

ISI Toolbox

ISI Publisher

eValidators

Acrobat

Veeva

Documentum

MS Word

MS PowerPoint

MS Excel

Job description

Regulatory Publishing Specialist

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

Job Title: Regulatory Publishing Specialist

Location: Gurugram/Hyderabad (Hybrid)

2+ 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.

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. May QC materials prepared by team or client.

May create, key, and assemble client deliverable documents and submissions using standard word processing or publishing systems and utilities (Extedo's eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat and others).

Takes 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.

May review documents for legibility, completeness, and accuracy.

May log and track regulatory documents, publications, and other relevant materials.

May organize and compile regulatory documentation, perform pagination, clean-up, and duplication tasks.

May receive and deliver client information/documents, with significant supervision.

May provide alternatives for completing assigned tasks.

Prepares and assembles applications (INDs, NDAs, ANDAs, DMFs, variations, routine reports, renewals etc.) for submission to global regulatory authorities.

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.
• Experience with relevant software such as Extedo's eCTDManager and eSUBmanager, ISI Toolbox, ISI Publisher, eValidators, Acrobat, Veeva, Documentum, MS Word.
• 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 ar