Regulatory Medical Writer

Parexel
Full Time • Hybrid • Remote
₹6 Lakhs - ₹9 Lakhs
Hyderabad, Bengaluru, Mohali
Posted 50m ago

Regulatory Medical Writer

Parexel

Job description

Are you considering a career in medical writing and pharmacovigilance? Explore this job opening at Parexel for the role of Medical Writer I / Medical Writer II.

 Company Description 

Parexel is a global clinical development and consulting organisation that works with biopharmaceutical companies and research sites to advance clinical research. With teams operating worldwide, the company supports the design and delivery of clinical trials, helping bring new treatments to patients. Its work focuses on scientific quality, patient-centred research, collaboration, and improving access to clinical studies.

 

 Job Summary 

The Medical Writer I / Medical Writer II - Patient Safety post is based in Hyderabad, Bengaluru, Mohali, and other locations across India. The role as a clinical writer entails preparation of regulatory safety reports, review of material from clinical databases and scientific literature, and preparation of assessments of potential drug safety signals. The scientific writer participates in the development of risk management paperwork, keeps records, and works with customers and internal teams. Medical Writer IIs also provide coaching to junior colleagues and help with complex reviews and process improvements.

 

 Key Responsibilities 

  • Prepare and compile regulatory safety reports including but not limited to Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs) and Development Safety Update Reports (DSURs) in an accurate and timely manner.

  • Independently review safety information from clinical databases, scientific literature and regulatory websites to detect potential medication safety signals using qualitative and quantitative methodologies.

  • Prepare Drug Safety Reports (DSRs) and Signal Evaluation Reports (SERs). Gather information from many sources and give evidence-based judgments.

  • Conduct organised literature searches and reviews to identify emerging safety trends and to support signal evaluation and epidemiologic evaluations.

  • Follow track signals and dig into discrepancies in safety data and documents to verify accuracy.

  • Assist in the preparation and revision of Risk Management Plans (RMPs) based on safety findings and relevant regulatory requirements.

  • Liaise with clients, provide progress updates, address regular concerns, and escalate complex situations as required.

  • Organise source papers, keep records audit-ready, and assist with regulatory inspection preparation.

  • Medical Writer II’s will mentor junior colleagues, lead challenging client discussions, organise document reviews, and participate in process improvement projects.

 
Educational Qualification 

  • University degree in Life Sciences, Health Sciences or Biomedical Sciences like Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Dentistry and Physiotherapy.

  • Equivalent combination of training and work experience may also be considered.

  • Medical Writer I: Minimum 2 years experience in medical writing, pharmacovigilance or related subject.

  • Medical Writer II: Minimum 4 years experience in pharmacovigilance, medical writing or related subject.

 
Skills Required  

  • Good scientific writing and critical thinking skills.

  • Understanding of pharmacovigilance practices and international regulatory regulations.

  • Understanding of medical language and ideas of medication safety.

  • Ability to analyse complex safety data and generate concise and accurate reports.

  • Knowledge of medical writing tools and Microsoft office software.

  • Knowledge of pharmacovigilance databases and coding dictionaries like MedDRA and WHO-DD.

  • Excellent communication and customer management skills.

  • Good time management and organizational abilities.

  • Attention to detail.

  • Ability to handle various assignments and meet deadlines.

  • For Medical Writer II, proven ability to coach colleagues, conduct difficult reviews and contribute to process improvements.

  • Other preferred qualities are prior safety assessment experience, hospital-based clinical exposure, direct clinical research experience, therapeutic area expertise, and knowledge of regulatory submissions across regions.


Salary Structure

The average salary of a Regulatory Medical Writer in India is in the range of ₹6 Lakhs - ₹9 Lakhs per year.


Career Development

This role, as a  Regulatory Medical Writer provides an opportunity to get experience in medical writing, pharmacovigilance, regulatory safety reporting and signal assessment. Medical Writer II professionals are also able to develop leadership abilities through mentoring, customer involvement and process improvement activities.

 

 How to Apply 

  • Visit our job portal and look for Regulatory Medical Writer role.

  • Click on the vacancy to read the full job description and eligibility.

  • Fill in the necessary personal, educational and professional information and attach your updated CV.

  • Review your application and submit it through the official recruitment portal.

 

Employment Type: Full Time • Hybrid • Remote
Industry: Healthcare
Role Category: Non Clinical Jobs
Application: External (Company Site)

Education

Bachelor's Degree

Key Skills

Non Clinical JobsMedical AffairsPharmacovigilance

Market insights & trends

Salary Insights

The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.

Hiring Trends

The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.

Frequently Asked Questions

Everything you need to know about the process

Jobslly curates specialized corporate healthcare listings tailored for medical graduates seeking a career pivot. Instead of sifting through general medical job boards, doctors can use our platform to directly access high-paying non-clinical opportunities in Pharmacovigilance, Medical Writing, and Clinical Trial Management with top pharmaceutical companies and CROs. Most MBBS/BDS grads don't realise — clinical background is already enough to get into pharma. The problem is nobody explains this clearly. On Jobslly each listing shows salary range, fresher eligibility, and certifications worth getting before applying. Pharmacovigilance roles for example keep asking for RQAP-GCP. All this is on the listing itself, no separate research needed.
Yes. Jobslly features dedicated filtering for remote and hybrid healthcare roles, which are highly sought after by medical professionals looking for better work-life balance. Doctors can easily track and apply for verified work from home positions, such as Telehealth Consultants, Medical Chart Reviewers, and Drug Safety Associates, directly through the platform Real problem with remote medical jobs — half are fake, half are badly described. You join and realise it's a night shift for a US team nobody mentioned. Jobslly listings show shift timings, contract type, whether company gives equipment or WFH allowance. All upfront before you apply.
Generic job portals often bury specialized clinical roles under thousands of unrelated listings. Jobslly is purpose-built exclusively for the healthcare and health-tech sectors. We provide doctors with targeted career alerts for niche specialties, direct application routes to premium employers in major hubs like Mumbai and Bangalore, and real-time insights into medical salary benchmarks. Salary benchmark is something doctors switching careers genuinely need. No idea what number to quote, quote low, stuck with it forever. Jobslly shows pay ranges — by role, city, experience level. Career alerts are filtered by specialty and location so inbox isn't flooded with irrelevant stuff daily.
To protect medical professionals from recruitment fraud and unverified agencies, Jobslly operates a strictly vetted ecosystem. We exclusively partner with verified employers, prioritizing NABH-accredited hospitals, established health-tech innovators, and recognized multinational pharma brands so you can apply with complete confidence. Fake agencies, ghost listings, upfront fee scams — very common in medical recruitment, especially pharma and international roles. Jobslly doesn't allow unregistered agents on platform at all. Each listing shows actual audit date, not just an old generic verified badge. Suspicious listing — report button is there, compliance checks within 24 hours.
Yes. Backed by the Academically Global network, Jobslly goes beyond domestic job listings by providing access to structured International Placement Programs. We connect ambitious doctors, nurses, and clinical staff with credible, high-paying healthcare contracts in global markets like the UK, Australia, and the UAE, while outlining the necessary credentialing steps. UK needs PLAB, Australia needs AMC, UAE needs DHA or HAAD depending on emirate. Most doctors know this but the full picture — exam pattern, timeline, cost, official links — is scattered everywhere. Jobslly puts the credentialing roadmap directly on each international listing. Academically Global counsellors also available — people who've actually placed Indian doctors in these countries, know exactly where candidates get stuck.
Forget the assumption that only senior doctors make the big money. That's outdated. Right now, some of the best packages in Indian healthcare are going to people you wouldn't expect — Senior Medical Writers, Clinical Data Managers, Pharmacovigilance Specialists working with global pharma firms or CROs. These aren't rare unicorn jobs. They exist, they hire regularly, and the salaries are negotiable in ways hospital jobs rarely are. Most candidates just don't know to look for them.
Not all cities are equal on this front, and applying blindly wastes time. Bangalore is where health-tech and clinical research hiring is concentrated. Hyderabad is pharma country – manufacturing, QC, formulation, R&D. Mumbai and Navi Mumbai handle specialized hospital care, advanced nursing roles, and pharmacovigilance admin, medical writing, policy work all coexist there without one dominating the other. If you're open to relocating, knowing this upfront changes which jobs you even bother applying for.
Both. That's the honest answer. Legitimate remote roles in healthcare have existed long before anyone started calling things "hybrid." Medical Coders, Pharmacovigilance Associates, Telehealth Coordinators, Freelance Medical Writers — these positions have been hiring remotely for years through companies that are very much real. The fake ones almost always have one thing in common: they ask for money. Registration fees, document processing charges, security deposits — whatever the label, it's a scam. No actual employer takes money from a candidate before they join. That rule holds without exception.
EMR platforms, digital documentation tools, data tracking systems, AI-assisted reporting software. These aren’t “nice to have” anymore. They’re baseline. Clinical Knowledge is still the foundation but walking into an interview unable to navigate the systems the team uses daily is a problem. Candidates who are already familiar with these tools don’t need to be trained from scratch, and that matters when hiring managers are comparing two otherwise similar profiles.
Short answer: yes, and it's happening constantly. Long answer: it depends on what you want. If structured hours, no emergency calls, and a salary that doesn't plateau after three years sound appealing — corporate healthcare is worth your attention. Medical Writing, Drug Safety Review, Insurance Auditing, Health-tech Program Management — these roles specifically want people who understand clinical realities. A nursing degree or MBBS isn't a handicap here. It's often the reason you get the interview.