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Senior Publishing Specialist (Ectd )

0-2 years
Not Disclosed
10 Nov. 5, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Publishing Specialist (eCTD)

Location: India - Remote
Updated: October 31, 2025
Job ID: 25102356
Company: Syneos Health®


About Syneos Health

Syneos Health® is a leading, fully integrated biopharmaceutical solutions organization built to accelerate customer success. Our Clinical Development model places both the customer and the patient at the center of everything we do.

We continually simplify and streamline our processes to make Syneos Health easier to work with and for — fostering collaboration, innovation, and agility in delivering life-changing therapies.

With a global team of 29,000 employees across 110 countries, Syneos Health has partnered in developing:

  • 94% of all Novel FDA Approved Drugs

  • 95% of EMA Authorized Products

  • 200+ studies across 73,000 sites and 675,000+ trial patients

Work Here Matters Everywhere.


Why Join Syneos Health

  • Career growth through structured development and progression programs

  • Supportive leadership and a collaborative environment

  • Technical and therapeutic area training opportunities

  • Recognition through peer programs and total rewards

  • Commitment to our Total Self Culture — fostering authenticity, inclusion, and belonging across global teams

We believe diverse perspectives drive innovation and create a workplace where everyone feels valued.


Job Responsibilities

As a Senior Publishing Specialist (eCTD), you will:

  • Perform assembler and publishing tasks within the publishing system under limited supervision

  • Support activities such as data filtering, cleaning, migration, analysis, reporting, and regulatory data publication

  • Ensure compliance with established processes and operating procedures

  • Participate in internal and external audits as required

This is a mid-level position requiring technical precision, regulatory acumen, and attention to detail in electronic submission management.


Key Qualifications

  • Relevant degree in Life Sciences, Pharmacy, or a related field

  • Prior experience in eCTD publishing, document assembly, or regulatory operations preferred

  • Strong understanding of submission standards and quality systems

  • Excellent organizational and analytical skills

  • Ability to work independently and collaboratively in a remote setting


Additional Information

  • Duties and responsibilities may evolve as per business needs

  • Equivalent education, skills, and experience will be considered

  • Syneos Health is committed to providing reasonable accommodations under the Americans with Disabilities Act (ADA)

  • We uphold full compliance with the EU Equality Directive and all relevant employment legislation


How to Apply

Interested candidates can apply directly through the Syneos Health Careers Page or join our Talent Network to stay updated on future opportunities.

At Syneos Health, we value transferable skills and encourage applicants from diverse backgrounds to apply — even if you don’t meet every listed qualification.

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