Are you an experienced Medical Writer looking for a rewarding career in global pharma regulatory affairs? MASUU, a leading global pharma regulatory, quality services, and software company, is expanding its team. We have immediate openings for talented and dedicated Medical Writers to author critical safety and regulatory documents for submissions worldwide. If you have expertise in CTD modules, Risk Management Plans (RMP), and PBRERs, this is your opportunity to grow with an industry innovator.
About MASUU Global
MASUU is a dynamic and growing company at the forefront of the pharmaceutical industry. We provide comprehensive regulatory, quality, and software solutions to help life sciences companies navigate the complex global compliance landscape. Our team of experts is dedicated to ensuring product safety, efficacy, and market compliance, empowering our clients to bring vital medicines to patients faster and more efficiently. Joining MASUU means becoming part of a collaborative culture that values expertise, innovation, and professional development.
Job Description: Medical Writer – Pharma Safety & Regulatory Documents
We are seeking two experienced Medical Writers to join our growing Regulatory Writing team in Hyderabad. In this crucial role, you will be responsible for authoring, reviewing, and managing key clinical and regulatory documents that support global regulatory submissions and ongoing compliance.
Vacancy Details:
- Role 1: Managerial Position – Requires 8-10 years of relevant experience.
- Role 2: Executive Position – Requires 2-4 years of relevant experience.
- Job Type: Full-Time, On-Site
- Location: Miyapur, Hyderabad (Work from Office – NO WFH option)
- Preferred Joining: Immediate Joiners or candidates with a notice period of less than 30 days.
Key Responsibilities:
As a Medical Writer at MASUU, you will:
- Author and review high-quality, critical regulatory documents, including:
- CTD Modules 2.5 (Clinical Overview) & 2.7 (Clinical Summaries)
- Risk Management Plans (RMP)
- Initial Paediatric Study Plans (iPSP)
- Study Protocols & Investigator Brochures (IB)
- Pre-IND and IND submission documents
- IMPDs (Investigational Medicinal Product Dossiers)
- Scientific Advice Packages
- Periodic Safety Update Reports (PSURs) and Periodic Benefit-Risk Evaluation Reports (PBRERs)
- Contribute to preparations for health authority interactions (including Type A, B, and C meetings).
- Ensure all documents align with ICH guidelines and global regulatory requirements.
- Collaborate effectively with multidisciplinary global teams, including Pharmacovigilance (PV), Clinical Development, Regulatory Affairs, Drug Safety, and Legal.
- Mentor junior medical writers and conduct thorough peer reviews of documents.
- Support the development and execution of regulatory writing strategies and deliverables.
Ideal Candidate Profile:
- Proven experience in authoring the aforementioned regulatory documents.
- In-depth knowledge of ICH guidelines and global regulatory submission processes.
- Strong ability to interpret and present complex clinical and scientific data.
- Excellent written and verbal communication skills in English.
- A team player with exceptional collaboration and project management skills.
- For the managerial role: Demonstrated experience in mentoring, peer review, and strategic input.
How to Apply
If you are ready to take the next step in your career as a Medical Writer, we encourage you to apply.
Please send your CV in the required format to the details below:
- Email:
hiring@masuuglobal.com - Call or WhatsApp: 9154979318 (Text Message)