Regulatory Medical Writer Jobs at Primus Global for drug documentation with hybrid work, global exposure, and long-term growth opportunities.
About the Company
Primus Global is a globally recognized consulting and staffing organization providing specialized services across clinical research, regulatory affairs, pharmacovigilance, and life sciences. The company partners with pharmaceutical sponsors, CROs, and healthcare organizations to support global drug development and regulatory submissions. Regulatory Medical Writer Jobs at Primus Global
Primus Global is known for delivering high-quality regulatory and medical writing solutions that comply with international guidelines and regulatory expectations. With a strong presence in India and global markets, the company offers professionals exposure to multinational projects, regulated environments, and flexible work models. Regulatory Medical Writer Jobs at Primus Global
By fostering a collaborative culture and emphasizing scientific excellence, Primus Global enables experienced professionals to advance their careers in regulatory documentation and clinical research. Regulatory Medical Writer Jobs at Primus Global
Job Details
- Job Title: Regulatory / Medical Writer (Drugs)
- Company: Primus Global
- Job Type: Full-Time
- Work Mode: Hybrid
- Industry: Pharmaceuticals / Clinical Research
- Experience Required: 4 to 10 years
- Job Locations:
- Bangalore
- Hyderabad
- Pune
- Mumbai
- Delhi NCR
- Education Required: Master’s Degree, Pharm.D, or Ph.D.
- Application Mode: Email Application
- Job Status: Verified Job
- Published On: January 14, 2026
Job Description
Primus Global is hiring experienced Regulatory and Medical Writers (Drugs) to support pharmaceutical regulatory documentation under a hybrid work model. This role is designed for professionals with strong hands-on experience in clinical and regulatory document authoring related to drug development (excluding medical devices). Regulatory Medical Writer Jobs at Primus Global
The selected candidates will be responsible for preparing high-quality clinical documents that support global regulatory submissions. This role offers long-term career growth, exposure to international regulatory standards, and the opportunity to work with cross-functional global teams. Regulatory Medical Writer Jobs at Primus Global
Professionals with expertise in Clinical Study Reports, CTD Modules, protocols, and investigator documentation will find this position highly rewarding in terms of learning, stability, and professional advancement. Regulatory Medical Writer Jobs at Primus Global
Key Responsibilities
- Author, review, and finalize clinical and regulatory documents for pharmaceutical products
- Prepare Clinical Study Reports (CSRs) in compliance with regulatory requirements
- Develop clinical trial protocols, protocol amendments, and related documents
- Draft and review Informed Consent Forms (ICFs) and Investigator Brochures (IBs)
- Prepare and support Common Technical Document (CTD) Module 2 and/or Module 5 content
- Ensure compliance with ICH-GCP guidelines, regulatory authority expectations, and sponsor standards
- Collaborate with clinical, regulatory affairs, biostatistics, and medical affairs teams
- Support global regulatory submissions such as IND, NDA, and ANDA where applicable
- Maintain document quality, version control, timelines, and submission readiness
- Address review comments and ensure scientific accuracy and consistency
Regulatory Medical Writer Jobs at Primus Global
Skills / Qualifications
Educational Qualifications
- Master’s degree in Life Sciences or Pharmacy
- Pharm.D
- Ph.D. in a relevant life sciences discipline
Experience Requirements
- 4 to 10 years of relevant experience in regulatory or medical writing
- Proven experience in pharmaceutical drug development documentation
- Experience strictly related to drugs (non-medical devices)
Regulatory Medical Writer Jobs at Primus Global
Technical & Professional Skills
- Strong hands-on experience with CSRs, CTD Modules 2 and 5, protocols, ICFs, and IBs
- In-depth knowledge of ICH guidelines and regulatory frameworks
- Familiarity with global regulatory submission processes
- Excellent scientific writing, editing, and review skills
- Strong communication and cross-functional collaboration abilities
- Ability to manage multiple documents and deadlines efficiently
Regulatory Medical Writer Jobs at Primus Global
Salary & Benefits
- Estimated Salary Range: ₹8,00,000 to ₹18,00,000 per annum (based on experience)
- Hybrid work model offering flexibility and work-life balance
- Exposure to global regulatory submissions and multinational clients
- Long-term career growth in regulatory and medical writing
- Professional and collaborative work environment
- Opportunity to work on complex and high-impact drug development projects
Regulatory Medical Writer Jobs at Primus Global
Why You Should Join
Joining Primus Global as a Regulatory or Medical Writer provides a unique opportunity to work on global pharmaceutical projects while enjoying the flexibility of a hybrid work model. Professionals gain valuable exposure to international regulatory submissions, evolving guidelines, and cross-functional collaboration.
The organization values scientific accuracy, regulatory compliance, and professional growth. This role allows experienced writers to strengthen their expertise in drug development documentation while contributing to therapies that impact global patient health.
With structured processes, experienced leadership, and long-term projects, Primus Global offers stability and continuous learning for regulatory and medical writing professionals. Regulatory Medical Writer Jobs at Primus Global
FAQs
Who can apply for this Regulatory / Medical Writer role?
Professionals with 4–10 years of experience in regulatory or medical writing within the pharmaceutical (drug) domain can apply.
Is this role applicable to medical device writers?
No. This role is strictly for drug-related regulatory and medical writing. Medical device experience is not applicable.
What is the work model for this job?
This is a hybrid role, combining remote and office-based work depending on project requirements.
Which locations are eligible for this position?
Candidates from Bangalore, Hyderabad, Pune, Mumbai, and Delhi NCR are eligible.
What type of documents will I work on?
You will work on CSRs, CTD Modules 2 and 5, protocols, ICFs, Investigator Brochures, and submission-related documents.
How to Apply
Interested and eligible candidates should share their updated CV via email:
Email ID: snath@primusglobal.com
Applicants are advised to clearly highlight their experience with Clinical Study Reports, CTD Modules, and regulatory submissions to improve shortlisting chances.
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