Manager, Medical Writing

Bangalore, Karnataka
Permanent
Full-time

1 day ago

Who we areTogether, we're on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It's a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world's leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.The opportunityA Manager, in Global Regulatory Medical Writing, writes and edits clinical regulatory documents, including submission summaries and other complex documents, provides basic-level oversight and guidance, as well as resource management for the direct medical-writing support in the production of clinical research documentation used in drug development and product registrations.How you'll spend your day

Primarily works at a project level.
Writes and edits clinical regulatory documents including study reports, protocols, briefing books, investigator's brochures, health authority responses, and other submission documents (e.g., module 2.5 and modules 2.7.x).
Compiles, analyzes, and summarizes data from various sources.
Conducts proofreading, editing, document formatting, and comment resolution.
Ensures documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
May participate in the preparation/revision of document templates and SOPs.
May train and support medical writers or external vendors/contractors on document planning, processes, and content development.

Your experience and qualifications

Bachelor's, Master's, MD, PhD, PharmD in life sciences (or other related field).
Preferred Master's, MD, PhD, PharmD.
University degree with a minimum of 5+ years of relevant experience; advanced degree preferred.
Proficient as lead author writing protocols/protocol amendments, clinical study reports, investigator's brochures, and clinical summary documents (modules 2.5 and 2.7.1-2.7.4)
6+ years with an advanced degree.
Travel Requirements: Up to 10%

Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to 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 entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

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