Manager-Regulatory Medical Writing

Job Purpose

Clinical Development department is one of the key departments at SPIL which handles, analyzes, and portrays scientific data and information. Providing authentic, objective, and accurate information to regulatory agencies, the scientific community, healthcare professionals, and patients in a consistent and timely fashion across the entire drug development cycle is fundamental to SPIL.

The purpose of SPIL Medical Writer is to work with cross-functional, multidisciplinary teams to author, manage, and lead the development of documents intended for regulatory agencies and audiences (including but not limited to Protocols, Clinical Study Reports, Investigator Brochures, Briefing Documents, Submission Documents, Health Authority Regulatory responses, IND/NDA Applications and Marketing Authorization Applications).

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

Full Time Part time

Job Location

Mumbai/ Gurgaon, INDIA

Reporting To

Global Medical Writing Lead/ Head - Global Medical Writing