Medical Writer - jobs at Teva in India, Bengaluru
Teva Manager Medical Writing India, Karnataka, Bengaluru
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A 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.
- 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.
- 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%
These jobs might be a good fit
Teva Manager Medical Writing India, Karnataka, Bengaluru
Share
A 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.
- Primarily works at project level
- May oversee contingent workers and/ or vendors; may provide training to others as needed
- Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents
- Writers and edits clinical regulatory documents, including submission summaries and other complex documents
- Ensures that these 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
- Phd or PharmD in life sciences (or other related field), or Master’s degree in life sciences (or other related field)
PhD or PharmD with a minimum of 2 years of experience OR Master’s degree with a minimum of 4 years of experience
These jobs might be a good fit
Teva Medical Writer - India, Karnataka, Bengaluru
Share
A 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.
- Primarily works at project level
- May oversee contingent workers and/ or vendors; may provide training to others as needed
- Offers leadership and basic accountability, provides strategic assistance, and planning support for clinical regulatory documents
- Writers and edits clinical regulatory documents, including submission summaries and other complex documents
- Ensures that these 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
- Phd or PharmD in life sciences (or other related field), or Master’s degree in life sciences (or other related field)
PhD or PharmD with a minimum of 2 years of experience OR Master’s degree with a minimum of 4 years of experience
These jobs might be a good fit
A 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.
- 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.
- 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%
These jobs might be a good fit
