Sr. Manager-Regulatory Medical Writing

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Job Purpose

Key Roles And Responsibilities

• Preparation of the medical writing documents under the purview of Clinical Development department that may be required for domestic and international regulatory submissions across the globe.
• Effectively collect, and evaluate data, information, and inputs from multiple functions, sources to create a cohesive content strategy for writing projects
• Plan including organizing/preparing outlines, write, edit, review, co-ordinate, obtain approval, and complete the regulatory documents supporting Clinical Development
• Conduct effective document initiation meetings and comments resolution meeting(s) to ensure review team alignment and understanding
• Ensure data are presented in a clear, complete, accurate, and concise manner.
• Ensure key data, statements, and conclusions are consistent across related documents and that inferences/conclusions are integrated, accurate, and supported by appropriate data.
• Coordinate scientific reviews, collate reviewer’s comments, develop content of document as required based on internal/external inputs, and prepare final version.
• Ensure and coordinate quality checks for accuracy; perform quality checks of documents
• Perform peer review of documents
• Exhibit flexibility in working across multiple document types and therapeutic areas
• Influence or negotiate content of document and timelines, with cross functional teams to deliver optimum quality documents
• Escalate issues if any, to medical writing supervisors/HOD
• Anticipate and mitigate risks to delivery
• Maintain and enhance TA knowledge of SPIL portfolio
• Maintain and be abreast of medical writing regulatory guidelines / policies/ procedures
• Maintain and enhance scientific knowledge skills to align with audience needs and changes in technology and platforms
• Provide coaching to others by sharing technical information and providing guidance
• Maintain/ support metrics, tracking sheets, and training records as per the process requirements
• Complete required trainings within stipulated due dates
• Be audit compliant and audit ready per organizational needs
• Network with others (medical writing team and other functions) to identify and share best practices.
• Contribute to process improvements
• May build and manage relationships with vendors, if required.
  

Qualification, Skill And Competencies Requirements

• Qualification: A doctoral or post-graduate degree in Life Science/Pharmacy disciplines or clinical degrees (MBBS/BDS/BAMS/BHMS, etc.) with minimum of 3 years of experience and good knowledge in regulatory medical writing, with proven and progressive leadership capabilities is required. Advanced degree (e.g., MD, PhD) is preferred…
• Skills and Competencies
• Good knowledge of scientific, statistical, and research principles and regulatory guidelines such as ICH requirements.
• Demonstrated written and/or communication skills.
• Demonstrated project management and decision-making skills.
• Demonstrated interpersonal skills to build relationships, act as change agent, and adapt to rapidly changing organizational & business challenges.
• Demonstrated innovative thinking to allow for optimal execution of clinical development strategies.
• Good knowledge of global regulations and pharma industry standards
  

Job Duration

Job Location

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