Job Title:
Principal Scientific Publisher – Formulation R&D
Date Posted:
12 Sept 2025
Location:
Ambernath, India, 421506
Company:
Teva Pharmaceuticals
Job ID:
63885
Company Overview:
Teva Pharmaceuticals is a global leader in generic and innovative medicines, committed to making healthcare more affordable and accessible. Operating in nearly 60 countries, Teva produces many products listed on the WHO Essential Medicines List.
Role Overview:
The Principal Scientific Publisher is responsible for preparing consistent, high-quality technical documents for Pharmaceutical Research & Development, specifically formulation-related documents, ensuring compliance with FDA, ICH, USP, cGMP, and company SOPs. This role requires minimal supervision and effective collaboration with R&D teams.
Key Responsibilities:
Documentation & Scientific Writing:
Prepare and manage technical documents in R&D, ensuring correctness, completeness, and clarity.
Create documents including:
Manufacturing Batch Records (MBRs)
Study Protocols and Reports
Stability Protocols
Product Development Reports
Quality Overall Summaries
Regulatory query responses
Incorporate scientific input from the Formulation team; apply QbD (Quality by Design) and DOE (Design of Experiments) principles.
Apply shelf-life extrapolation and statistical analysis where required.
Prepare high-impact presentations, including graphs and charts.
Process & Compliance:
Submit documents for approval, coordinate their flow, archival, and retrieval.
Maintain documentation systems to improve efficiency and regulatory compliance.
Ensure adherence to FDA guidelines and company data integrity policies.
Perform other duties as assigned to support R&D documentation needs.
Collaboration & Communication:
Maintain open communication with R&D members to ensure timely delivery of high-quality documents.
Assist in facilitating cross-functional communication and documentation flow.
Experience & Qualifications:
Education:
Required: Master’s degree (M.Pharm) or PhD in Pharmacy.
Experience:
Minimum 12–15 years of Formulation R&D experience with solid oral dosage forms for regulated markets.
Knowledge of other dosage forms is a plus.
Demonstrated understanding of quality and regulatory guidance for SOD products.
Working knowledge of Good Manufacturing Practices (GMP) and regulatory documentation standards.
Skills & Competencies:
Communication Skills:
Excellent written and verbal communication in English.
Advanced technical writing abilities.
Strong presentation skills and proficiency in scientific communication platforms.
Computer Skills:
Proficient in Microsoft Word, Excel, and PowerPoint.
Knowledge of statistical tools for data mapping/trending preferred.
Familiarity with databases, spreadsheets, and structural drawing software.
Other Skills:
Strong organization, attention to detail, and problem-solving abilities.
Ability to work independently in a fast-paced team environment.
Good documentation practices and adherence to technical writing principles.
Equal Opportunity Statement:
Teva Pharmaceuticals provides equal employment opportunities without regard to age, race, creed, color, religion, sex, disability, pregnancy, sexual orientation, gender identity, or other legally protected status. Reasonable accommodations are provided throughout the recruitment process.
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