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Principal Scientific Publisher Frd

12-15 years
Not Disclosed
10 Sept. 15, 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

Job Title:

Principal Scientific Publisher – FRD

Date Posted:

September 12, 2025

Location:

Ambernath, India, 421506

Company:

Teva Pharmaceuticals


Company Overview:

Teva Pharmaceuticals is committed to making health more affordable and accessible, helping millions globally live healthier lives. With operations in nearly 60 countries, Teva is a leading manufacturer of generic medicines and a producer of many WHO Essential Medicines.


Role Overview:

The Principal Scientific Publisher is responsible for preparing high-quality technical documents for Pharmaceutical Research & Development, specifically related to formulation. The role ensures all documentation complies with FDA regulations, ICH guidelines, USP methodologies, cGMP, and internal SOPs. The position requires independent work with minimal supervision while maintaining clear communication with R&D teams.


Key Responsibilities:

  • Prepare and manage R&D documentation while ensuring correctness, completeness, and clarity.

  • Develop documents such as:

    • Manufacturing Batch Records

    • Study Protocols and Reports

    • Stability Protocols

    • Product Development Reports

    • Quality Overall Summary

    • Regulatory query responses

  • Apply knowledge of QbD (Quality by Design) and DOE (Design of Experiments).

  • Perform shelf-life extrapolation and statistical analysis (preferred).

  • Prepare high-impact presentations, including graphs and charts.

  • Manage document submission, review, approval workflows, archival, and retrieval.

  • Continuously improve documentation systems to ensure compliance with cGMP and regulatory requirements.

  • Adhere to FDA guidelines and company policies, including Data Integrity.

  • Perform other duties as assigned.


Qualifications & Experience:

  • Education: Master’s degree (M.Pharm) or PhD in Pharmacy.

  • Experience:

    • 12–15 years in Formulation R&D for solid oral dosage forms in regulated markets.

    • Knowledge of other dosage forms is an advantage.

    • Strong understanding of quality and regulatory guidance for SOD products.

    • Familiarity with GMP and regulatory documentation practices.


Skills & Competencies:

Communication Skills:

  • Clear, structured writing and verbal communication in English.

  • Advanced technical writing abilities.

  • Familiarity with business and scientific communication platforms.

Computer Skills:

  • Proficient in Microsoft Word, Excel, PowerPoint.

  • Knowledge of statistical tools for data mapping/trending (preferred).

  • Familiarity with Windows-based databases, spreadsheets, and communication tools.

Other Skills:

  • Strong organization and attention to detail.

  • Ability to work independently in a fast-paced environment.

  • Strong problem-solving skills and technical knowledge.

  • Good documentation skills and understanding of technical writing principles.


Equal Employment Opportunity:

Teva Pharmaceuticals is committed to equal opportunity employment and a diverse, inclusive workplace. All accommodations for recruitment and selection are treated confidentially.