דרושים Medical Writer - ב-טבע ב-India, Bengaluru

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%

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

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