Regulatory Publishing Specialist

3004 Syneos Health UK Limited; Gurugram District; Hybrid; INR 900,000 - 1,500,000; Full time

Benefits offered by this job

Hybrid work model

Professional development

Job summary

Syneos Health UK Limited is seeking a Regulatory Publishing Specialist for Gurugram/Hyderabad (Hybrid). The role requires 2+ years of regulatory publishing experience and a BA/BS in a science-related field.

You will assemble, publish, and QC regulatory submissions using Extedo tools and related software. Responsibilities include preparing submissions (INDs, NDAs, ANDAs, DMFs, variations), troubleshooting eCTD builds, guiding junior publishers, and maintaining accurate regulatory documents with

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 submission requirements of various markets such as USFDA, EMA etc. an advantage.

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 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.

Skills

MS Word

PowerPoint

Excel

eCTDManager

eSUBmanager

ISI Toolbox

ISI Publisher

eValidators

Acrobat

Veeva

Documentum

Education

BA/BS in Science preferred

Tools

Extedo’s eCTDManager

Extedo’s eSUBmanager

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 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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to:

• Partner with the most diverse team of experts in the industry.
• From the top down, our people are inspiring.
• Everyone has a voice and is encouraged to use it.
• Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams.
• With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.
• We are partners with purpose.
• We integrate seamlessly with our customers and do what’s best for their success.
• Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.