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Medical Writing Associate Ii

Teva Pharmaceuticals

8-9 years

Not Disclosed

India Navi Mumbai

10 Feb. 12, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ 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: Medical Writing Associate II
Location: Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job ID: 60242
Date: January 16, 2025

About Teva Pharmaceuticals:

Teva Pharmaceuticals is a global leader in making healthcare more affordable and accessible. As the world’s leading manufacturer of generic medicines, Teva has positively impacted the lives of millions globally, providing essential medicines listed by the World Health Organization. Teva is dedicated to improving the health of individuals across nearly 60 countries, ensuring that quality medicines reach those who need them most.

The Opportunity:

Teva Pharmaceuticals is seeking a Medical Writing Associate II to join the team in Navi Mumbai, India. This role involves preparing and reviewing clinical study reports (CSRs), appendices, and other related documents, ensuring compliance with regulatory and sponsor requirements. The position also includes preparing study reports for clinical trials, coordinating with different departments, and mentoring new recruits.

Key Responsibilities:

Prepare & Review Documents: Prepare and review CSRs, appendices, bio summary tables, and other related documents in accordance with regulatory/sponsor requirements.
Coordination & Timelines: Work closely with concerned departments to ensure timely delivery and compliance of reports with regulatory and sponsor requirements.
Study Reports: Prepare reports for CE/PK studies and Brand studies, addressing any sponsor queries related to medical writing.
Amendments & Updates: Revise and update CSRs as required and prepare amended reports when necessary.
Electronic Submission: Electronically generate, review, and submit study documents and reports in CTD/eCTD format as per regulatory standards.
Adverse Event Coding: Provide MedDRA® coding for all adverse events recorded in clinical trials.
Quality Check: Perform final quality checks on compiled study reports before delivery.
Mentorship: Provide training to new recruits on the preparation of CSRs and other relevant documents. Act as a subject matter expert (SME) and mentor the team.
Project Leadership: Lead projects as assigned and contribute to system improvements as required by business needs.

Qualifications & Experience:

Experience: 8+ years in medical writing or related technical operations.
Educational Requirements: M.Sc., M.Pharm, or equivalent.
Skills & Competencies:
- Strong experience in preparing and reviewing clinical study reports.
- Knowledge of regulatory and sponsor requirements for clinical trials.
- Familiarity with eCTD/CTD submission formats.
- Proficiency in MedDRA® coding for adverse events.
- Excellent communication skills and the ability to manage multiple projects simultaneously.
- Ability to mentor and train new team members effectively.

APPLY NOW
For more details, visit Teva Pharmaceuticals Careers.

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Medical Writing Associate Ii

Job Description

About Teva Pharmaceuticals:

The Opportunity:

Key Responsibilities:

Qualifications & Experience:

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