Opella is a global leader in the Over-The-Counter (OTC) and Vitamins, Minerals & Supplements (VMS) market, ranking third globally. As a B Corp-certified company in many markets, Opella’s mission is simple: “Health. In Your Hands.”
📋 Job Description: Project Specialist – eDS
As a Project Specialist – Electronic Documentation Specialist (eDS), you will ensure submission-readiness and format validation of scientific and regulatory documents like CTD, PSMF, and Clinical Documents using electronic Document Management Systems (eDMS). You’ll work closely with Medical Writers, Regulatory Affairs, and Clinical teams globally.
Key Responsibilities:
- Perform document publishing/compilation using tools like Adobe Acrobat, ISI Toolbox, and Veeva Vault RIM.
- Validate formatting and readiness of documents for submission to Health Authorities.
- Manage eDMS workflows, including creating “binders” and setting internal document links.
- Support Medical Writing teams, ensure metadata compliance, and maintain naming conventions.
- Coordinate with vendors/CROs, providing technical guidance and managing outsourced documentation work.
- Deliver training on eDMS usage and contribute to the development of documentation tools and SOPs.
- Assist in building electronic Table of Contents (eTOC) for eCTD submissions.
🎓 Eligibility Criteria
| Criteria | Details |
|---|---|
| Education | Graduate/Postgraduate in Life Sciences |
| Experience | 1–3 years in the pharmaceutical industry, especially in eDMS, eCTD, project coordination |
| Technical Skills | MS Word, Adobe Acrobat (ISI Toolbox), Veeva Vault, eDMS systems, MS Office 365 |
| Soft Skills | Stakeholder management, communication, time prioritization |
| Language | Proficiency in spoken and written English |
Graduate/Postgraduate in Life Sciences includes:
B.Sc. in Biotechnology, Microbiology, Biochemistry, Biology, Zoology, Botany, Genetics, B.Pharm, B.Tech in Biotechnology, Bioinformatics, M.Sc. in Biotechnology, Microbiology, Biochemistry, Molecular Biology, Genetics, Pharmacology, M.Pharm, M.Tech in Biotechnology, Bioinformatics, Master of Public Health (MPH), Biomedical Engineering, Pharmaceutical Sciences, Clinical Research.
🌟 Why Join Opella?
- 🚀 Be part of a purpose-driven company revolutionizing self-care health.
- 🌍 Work with a global team committed to simplicity, collaboration, and innovation.
- 🌿 Certified B Corp status in multiple markets shows our commitment to people and planet.
- 📈 Access to learning & development programs and global exposure.
- 🧘 Health & wellness support with a focus on work-life balance.
