📌 Core Information
🔹 Job Title: Medical Writer Group Lead
🔹 Company: Sitero LLC
🔹 Location: Mysore, Karnataka, India
🔹 Job Type: On-site
🔹 Category: Research Services
🔹 Date Posted: April 15, 2025
🔹 Experience Level: 10+ years
🔹 Remote Status: On-site
🚀 Job Overview
Key aspects of this role include:
- Leading the development of high-quality clinical and regulatory documents across multiple therapeutic areas.
- Collaborating with sponsors and internal cross-functional teams to deliver key documents.
- Authoring and reviewing documents such as Clinical Study Reports (CSRs), Patient Narratives, Investigator’s Brochures (IBs), Protocols, and more.
- Ensuring compliance with ICH-GCP, sponsor-specific templates, and global regulatory requirements.
ASSUMPTION: This role requires a high level of expertise in medical writing and a deep understanding of clinical trial documentation and regulatory submissions.
📋 Key Responsibilities
✅ Prepare, write, and review a range of clinical and regulatory documents in compliance with ICH-GCP, sponsor-specific templates, and global regulatory requirements.
✅ Deliver high-quality, accurate, and scientifically sound documents including Clinical Study Reports (CSRs), Patient Safety Narratives, Investigator’s Brochures (IBs), Clinical Study Protocols and Amendments, Protocol Synopses, Clinical Trial Summaries, and other regulatory submissions.
✅ Interpret and present clinical data from statistical tables, listings, and figures.
✅ Liaise with cross-functional teams including clinical, biostatistics, pharmacovigilance, and project management to ensure timely document delivery.
✅ Communicate effectively with sponsor teams and manage feedback and revisions collaboratively.
✅ Maintain version control and ensure adherence to timelines, SOPs, and quality standards.
ASSUMPTION: This role requires strong attention to detail, excellent communication skills, and the ability to manage multiple projects simultaneously.
🎯 Required Qualifications
Education: Bachelor’s, Master’s, or PhD in Life Sciences, Pharmacy, Medicine, or a related discipline.
Experience: Minimum 8 - 12 years of medical writing experience in a CRO or similar clinical research environment.
Required Skills:
- Proficient in MS Office (Word, Excel, PowerPoint) and familiarity with document management systems.
- Excellent written and verbal communication skills.
- Strong analytical and organizational skills, with the ability to manage multiple projects simultaneously.
- Demonstrated experience with ICH guidelines and global regulatory requirements.
Preferred Skills:
- Experience with eCTD submissions and regulatory agency interactions.
- Familiarity with therapeutic areas such as oncology, CNS, cardiovascular, or rare diseases.
- Knowledge of tools like Adobe Acrobat Pro, and referencing software.
ASSUMPTION: Candidates with experience in a specific therapeutic area may be preferred, but a strong medical writing background is essential.
💰 Compensation & Benefits
Salary Range: INR 15,00,000 - 20,00,000 per annum (Estimated based on industry standards for a senior medical writer role in India)
Benefits:
- Health insurance
- Retirement benefits
- Paid time off
- Professional development opportunities
Working Hours: Full-time, 40 hours per week. May require flexible hours to meet project deadlines.
ASSUMPTION: The salary range provided is an estimate based on industry standards and may vary depending on the candidate's experience and qualifications.
📌 Applicant Insights
🔍 Company Context
Industry: Sitero is a next-generation, site-focused clinical research organization (CRO) that helps get treatments to market safer and faster through tech-forward services that streamline research.
Company Size: Sitero has 201-500 employees, providing a mid-sized company environment with opportunities for growth and collaboration.
Founded: Sitero was founded in 2014 and has since grown to have offices in the U.S., U.K., and India.
Company Description:
- Sitero combines the expertise of a tenured team with a nimble, innovative approach to clinical research.
- The company offers tech-forward services that streamline research, helping to accelerate clinical trials and drive compliance and safety.
- Sitero provides access to powerful technology and world-class services, unlocking innovation for life sciences and institutional research organizations.
Company Specialties:
- Clinical trial services
- Site-focused CRO solutions
- Technology-enabled clinical research
Company Website: www.sitero.com
ASSUMPTION: Sitero's focus on technology and innovation may attract candidates interested in staying at the forefront of clinical research.
📊 Role Analysis
Career Level: This role is at the senior level, requiring a high degree of expertise and experience in medical writing.
Reporting Structure: The Medical Writer Group Lead will likely report to the Head of Medical Writing or a similar senior role within the organization.
Work Arrangement: This is an on-site role, requiring the candidate to work from Sitero's office in Mysore, Karnataka.
Growth Opportunities:
- Potential to lead and mentor junior medical writers.
- Opportunities to work on diverse therapeutic areas and gain expertise in various aspects of clinical trial documentation.
- Possibility to advance to a more senior role within the medical writing department or take on a leadership position in the organization.
ASSUMPTION: Given Sitero's focus on growth and innovation, there may be ample opportunities for career advancement within the organization.
🌍 Location & Work Environment
Office Type: Sitero's office in Mysore, Karnataka is a professional, collaborative workspace designed to facilitate teamwork and innovation.
Office Location(s): 3121 Ponce de Leon Blvd, Coral Gables, Florida, US (Headquarters); Mysore, Karnataka, India (This role)
Geographic Context:
- Mysore is a mid-sized city in the state of Karnataka, India, known for its historical and cultural significance.
- The city offers a moderate cost of living and a pleasant climate, with warm weather year-round.
- Mysore is well-connected by road, rail, and air, making it easily accessible from other major cities in India.
Work Schedule: Full-time, 40 hours per week. May require flexible hours to meet project deadlines.
ASSUMPTION: Candidates should be comfortable working in a collaborative, fast-paced environment and be willing to adapt to the needs of the project.
💼 Interview & Application Insights
Typical Process:
- Online application and resume screening
- Phone or video screening
- On-site or virtual interview with the hiring manager and/or team members
- Background check and offer extension
Key Assessment Areas:
- Medical writing skills and experience
- Understanding of ICH guidelines and regulatory requirements
- Communication and interpersonal skills
- Problem-solving and analytical skills
- Cultural fit and alignment with Sitero's values
Application Tips:
- Tailor your resume to highlight your medical writing experience and relevant skills.
- Prepare examples of your medical writing work, demonstrating your ability to meet ICH guidelines and regulatory requirements.
- Research Sitero's company culture and be prepared to discuss how your values align with theirs.
- Prepare questions to ask the interviewer about the role, the team, and the company to demonstrate your interest and engagement.
ATS Keywords: Medical Writing, Clinical Documentation, Regulatory Submissions, ICH Guidelines, Statistical Data Interpretation, Cross-Functional Collaboration, Version Control, Project Management, Communication Skills, Analytical Skills, Organizational Skills, MS Office Proficiency, Document Management Systems, Therapeutic Area Knowledge, eCTD Submissions, Adobe Acrobat Pro
ASSUMPTION: Sitero uses an Applicant Tracking System (ATS) to manage job applications, so including relevant keywords in your resume can help ensure your application is seen by the hiring team.
🛠️ Tools & Technologies
- MS Office (Word, Excel, PowerPoint)
- Document management systems (e.g., Veeva Vault, Documentum, etc.)
- Adobe Acrobat Pro
- eCTD publishing tools (e.g., ArisGlobal's LifeSphere Publishing, Oracle's Argus, etc.)
ASSUMPTION: Familiarity with these tools is not required but may be an advantage for candidates.
👔 Cultural Fit Considerations
Company Values:
- Innovation
- Collaboration
- Expertise
- Integrity
- Patient focus
Work Style:
- Fast-paced and dynamic
- Collaborative and team-oriented
- Focused on continuous learning and improvement
- Adaptable and flexible
Self-Assessment Questions:
- Do you thrive in a fast-paced, collaborative environment?
- Are you comfortable working with cross-functional teams and managing feedback from multiple stakeholders?
- Do you have a strong attention to detail and a commitment to maintaining high-quality standards?
- Are you open to learning and adapting to new tools and technologies?
ASSUMPTION: Candidates who are a strong cultural fit for Sitero will be adaptable, collaborative, and committed to continuous learning and improvement.
⚠️ Potential Challenges
- Managing multiple projects simultaneously and meeting tight deadlines.
- Adapting to the needs of diverse therapeutic areas and regulatory requirements.
- Working with cross-functional teams and managing feedback from multiple stakeholders.
- Keeping up with the latest developments in medical writing and regulatory submissions.
ASSUMPTION: These challenges can be overcome by strong organizational skills, effective communication, and a commitment to continuous learning and improvement.
📈 Similar Roles Comparison
- This role is similar to a Senior Medical Writer or Medical Writing Manager position in a CRO or pharmaceutical company.
- However, Sitero's focus on technology and innovation may provide unique opportunities for growth and development.
- Career paths for this role may include advancing to a more senior medical writing position, taking on a leadership role within the medical writing department, or transitioning into a related field such as regulatory affairs or clinical operations.
ASSUMPTION: Candidates should consider their long-term career goals and how this role aligns with their desired career path.
📝 Sample Projects
- Preparing a Clinical Study Report (CSR) for a Phase III oncology trial.
- Writing an Investigator's Brochure (IB) for a rare disease program.
- Interpreting and presenting clinical data from statistical tables, listings, and figures for a regulatory submission.
ASSUMPTION: These sample projects are intended to give candidates an idea of the types of tasks they may be responsible for in this role.
❓ Key Questions to Ask During Interview
- Can you describe the team structure and how this role fits within the organization?
- What are the most challenging aspects of this role, and how has the previous incumbent approached them?
- How does Sitero support the professional development and growth of its medical writers?
- What are the key priorities for this role in the first 90 days?
- How does Sitero ensure the quality and compliance of its medical writing services?
ASSUMPTION: Asking thoughtful questions demonstrates your interest in the role and provides valuable insights into the company and the team.
📌 Next Steps for Applicants
To apply for this position:
- Submit your application through this link
- Tailor your resume to highlight your medical writing experience and relevant skills.
- Prepare examples of your medical writing work, demonstrating your ability to meet ICH guidelines and regulatory requirements.
- Research Sitero's company culture and be prepared to discuss how your values align with theirs.
- Prepare questions to ask the interviewer about the role, the team, and the company to demonstrate your interest and engagement.
- Follow up with the hiring manager within one week of submitting your application to express your continued interest in the role.
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
