Global Regulatory Writing - Senior Associate

Amgen
Full Time
₹14.6 Lakhs - ₹16.7 Lakhs
Hyderabad
Posted 1h ago

Global Regulatory Writing - Senior Associate

Amgen

Job description

Amgen is hiring a Global Regulatory Writing Senior Associate in Hyderabad, offering a great career opportunity for experienced medical writers in regulatory documents.

Company Description 

Amgen is a biotechnology pioneer that uses biology and technology to fight the world’s diseases. The company is a leader that discovers, develops, makes, and delivers medicines that help millions of patients. Amgen helped build the biotechnology industry forty years later than forty years ago and has been a pioneer since 1980. The company focuses on areas of unmet medical need and uses human genetic data to push beyond what is known. Amgen continues to push beyond known boundaries.

Job Summary  

This position is for a Global Regulatory Writing Senior Associate located in Hyderabad. The person will create simple to complex regulatory documents like consent forms, sections of study reports, and changes to protocols. The job involves handling document versions, responding to comments from reviewers, and getting approvals from beginning to end. It also requires working with clinical teams, safety teams, regulatory teams, and study teams.

Key Responsibilities 

  • Write regulatory documents on your own, including informed consent forms and their changes.

  • Write plain language summaries and clinical study report sections, with guidance for key reports.

  • Write protocol changes and country-specific protocol additions.

  • Write minor updates to investigator brochures.

  • Manage document versions, reviewer comments, and approval steps from start to finish.

  • Make sure documents are scientifically accurate, consistent, and match the source data and program goals.

  • Prepare documents that are ready for quality checks and inspections, as per guidance, SOPs, and regulations.

  • Work with clinical, safety, regulatory, and study teams to clear up questions and add feedback.

  • Join document-related meetings when needed.

  • Take part in training, knowledge sharing, and process improvement work.

Educational Qualification 

A master's degree is required, along with 5 to 8 years of directly related experience.

Skills Required 

  • Strong skills in managing work with many teams.

  • Clear communication and presentation skills.

  • Good timeline planning and ability to manage several deliverables at once.

  • Skill in spotting and reducing risks.

  • Review coordination and comment resolution skills.

  • Good use of document management systems, RIM tools, SharePoint, and document authoring tools.

Salary Structure 

The average salary for a Global Regulatory Writing Senior Associate at Amgen in Hyderabad ranges from ₹14.6 Lakhs to ₹16.7 Lakhs per year.

Career Development 

This role builds strong skills in regulatory writing and document management within a leading global biotech company. It can help you grow into a principal regulatory writer or wider regulatory and medical writing leadership roles over time.

How to Apply 

  • Visit our job portal and search for the Global Regulatory Writing Senior Associate role at Amgen, Hyderabad.

  • Click on the job posting to see all the details about the job.

  • Enter your information and add your resume.

  • Send your application.

Employment Type: Full Time
Industry: Healthcare
Role Category: Clinical Research
Application: External (Company Site)

Education

Postgraduate Degree (Master's/PhD)

Key Skills

Clinical ResearchNon Clinical Jobs

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.