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Medical Writing Associate Ii

3-8 years
Not Disclosed
10 July 26, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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

Who We Are

At Teva Pharmaceuticals, our mission is to make good health more affordable and accessible, helping millions of people around the world live healthier lives. This mission unites our team, which spans nearly 60 countries and includes a rich diversity of nationalities and backgrounds. As the world’s leading manufacturer of generic medicines and a key producer of products on the World Health Organization’s Essential Medicines List, we impact the lives of at least 200 million people daily. We are constantly seeking new ways to enhance our contributions and invite new talent to join us in making a difference.

How You’ll Spend Your Day

  • Regulatory Affairs (RA) Writing: Utilize your background in RA writing to prepare documents for Module 2, including sections 2.4 (Nonclinical Overview), 2.5 (Clinical Overview), 2.6 (Nonclinical Written and Tabulated Summary), and 2.7 (Clinical Written and Tabulated Summary) based on specific market requirements.
  • Literature Search and Analysis: Conduct extensive literature searches to support the basic elements of documents, including summaries of safety, efficacy, and bioequivalence studies, referencing standard medical product characteristics (SmPC).
  • Database Utilization: Leverage reliable databases like Embase, Clinical Pharmacology, Cochrane Library, PubMed, ScienceDirect, and Micromedex for comprehensive information gathering.
  • Document Preparation: Interpret templates and organize literature references according to the sub-sections of Modules 4 and 5, ensuring accurate and thorough documentation.
  • Electronic Data Capture: Use tools like GRIDS to import expert reviews and support the final submission of documents.

Your Experience and Qualifications

  • Experience: 3-8 years in Regulatory Affairs Writing
  • Education: Master of Pharmacy (Pharmacology)

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is dedicated to providing equal employment opportunities for all. Our global policy ensures equal opportunity regardless of age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin, or any other legally recognized status. We are committed to fostering a diverse and inclusive workplace. If you are contacted for a job opportunity, please inform us of any accommodations needed to support you during the recruitment and selection process. All accommodation information will be treated confidentially and used solely to ensure an accessible candidate experience.