Regulatory Publishing Specialist (eCTD )

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.

Job Responsibilities:

• 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.
• Performs Assembler tasks within the document publishing system, including 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 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 provides 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, performs 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.

Benefits:

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality‑of‑life balance. The benefits for this position may include a company car or car allowance, health benefits to include medical, dental and vision, company match 401k, eligibility to participate in Employee Stock Purchase Plan, eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.