Planet Pharma
Website:
planet-pharma.com
Job details:
Principal Medical Writer
Location: Remote - India,
Category: Clinical Development and Operations
Salary: Apply for details
Country: India
Employment: Contract
Worksite: On-Site
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Job Description
Principal Medical Writer
Location: India (Remote/Hybrid)
About The Opportunity
We’re supporting a global clinical research organisation that is continuing to invest in its Medical Writing capability following continued growth across its Functional Service Provider (FSP) business.
This is an opportunity for an experienced Principal Medical Writer to join an established global team supporting international pharmaceutical and biotechnology clients. You’ll take ownership of complex regulatory writing projects, work directly with global sponsors and play a key role in delivering high-quality submission documents across multiple therapeutic areas.
This role offers a high level of autonomy and would suit someone who enjoys leading projects, working directly with clients and mentoring junior team members, while remaining hands-on with medical writing.
Key Responsibilities
- Lead the preparation of complex clinical and regulatory documents for global development programmes.
- Prepare Clinical Module 2 submission documents, including:
- Clinical Overview
- Summary of Biopharmaceutics
- Summary of Clinical Pharmacology
- Summary of Clinical Efficacy
- Summary of Clinical Safety
- Briefing Documents
- Responses to Health Authority Questions
- Develop and review Clinical Study Protocols, Clinical Study Reports (CSRs) and other regulatory documents.
- Work closely with Clinical Operations, Biostatistics, Regulatory Affairs and Medical teams throughout the document development process.
- Provide scientific review of clinical documentation to ensure quality, consistency and regulatory compliance.
- Manage multiple writing projects simultaneously while meeting timelines and quality expectations.
- Mentor and support less experienced Medical Writers.
- Contribute to process improvements and medical writing best practices.
- Support proposal development and client-facing activities where required.
What We’re Looking For
- Degree in Life Sciences or a related scientific discipline (Master’s or PhD advantageous).
- Approximately 6+ years’ Medical Writing experience within a CRO, pharmaceutical or biotechnology environment.
- Strong experience preparing Clinical Module 2 submission documents.
- Excellent knowledge of ICH guidelines and global regulatory requirements.
- Experience leading complex writing projects and working independently.
- Strong communication and stakeholder management skills.
Why Consider This Opportunity?
- Join a growing global Medical Writing team supporting international development programmes.
- Work directly with leading pharmaceutical and biotechnology sponsors.
- Take ownership of submission-level regulatory documentation with real impact on global drug development.
- Opportunity to mentor colleagues while remaining technically hands-on.
- Exposure to a broad range of therapeutic areas and global regulatory submissions.
- Flexible working environment with long-term contract potential.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
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