Amneal Pharmaceuticals is hiring experienced life sciences professionals for two exciting opportunities in Ahmedabad, Gujarat. The company is currently looking for talented candidates for roles in Clinical Affairs and Medical Writing, Clinical Development.
These opportunities are ideal for professionals with experience in clinical research, regulatory affairs, clinical trials, ICH-GCP, FDA submissions, medical writing, pharmacovigilance, and drug development.
The selected candidates will support global clinical development programs and collaborate with cross-functional teams involved in clinical operations, regulatory submissions, safety reporting, scientific documentation, and clinical trial management.
Open Positions at Amneal
1. Senior Executive, Clinical Affairs
Location: Ahmedabad City, Gujarat, India
Experience: 6+ Years
Education: Bachelor’s Degree in Science required; Master’s Degree preferred
Industry: Pharmaceutical / Clinical Research / Regulatory Affairs
Role Overview
The Senior Executive, Clinical Affairs will provide operational and administrative support to global clinical trial teams working on New Chemical Entity (NCE) development programs.
The role involves supporting Phase 1โ4 clinical trials, maintaining clinical trial documentation, coordinating regulatory submissions, tracking study activities, communicating with clinical sites and vendors, and ensuring compliance with ICH-GCP and global regulatory requirements.
Key Responsibilities
- Provide operational and administrative support for global Phase 1โ4 clinical trials.
- Maintain the Trial Master File (TMF) and ensure quality control and timely filing of essential documents.
- Track study milestones, site initiation activities, patient recruitment, and study close-out.
- Support protocol amendments and updates to Investigator’s Brochures (IBs).
- Assist with Informed Consent Form (ICF) revisions.
- Prepare clinical study documents, monitoring plans, site manuals, and training materials.
- Support regulatory and ethics committee submission packages.
- Assist with IND and CTA submissions, amendments, and annual reports.
- Maintain regulatory correspondence and submission trackers.
- Coordinate safety reporting documentation, including SUSARs, DSURs, and PSURs.
- Coordinate communication with global clinical sites, CROs, laboratories, and vendors.
- Support site feasibility, selection documentation, and contract tracking.
- Assist with vendor oversight documentation.
- Reconcile clinical trial documents, data listings, and monitoring reports.
- Ensure compliance with ICH-GCP, FDA, EMA, CDSCO requirements, and internal SOPs.
- Participate in audit and inspection readiness activities.
- Support digital and AI/ML-enabled clinical trial operations.
- Maintain clinical project documentation repositories and version control.
- Prepare meeting minutes, trackers, action items, and management reports.
Required Skills
- Clinical Research
- Clinical Trial Operations
- Good Clinical Practices (GCP)
- ICH Guidelines
- Regulatory Affairs
- FDA Regulatory Requirements
- TMF Management
- CTMS and EDC systems
- Project Planning
- Risk Management
- Documentation and Technical Writing
- Stakeholder Management
- Attention to Detail
2. Executive, Clinical Affairs โ Medical Writer, Clinical Development
Location: Ahmedabad, Gujarat, India
Experience: 5+ Years
Education: Bachelor’s Degree in Science required
Preferred Education: Master’s Degree / Pharm.D / MD or related Life Sciences qualification
Job Category: Technical / Medical Writing
Job Schedule: Full-Time
Job ID: 8945
Apply Before: September 13, 2026
Role Overview
The Medical Writer, Clinical Development will be responsible for authoring, reviewing, and managing high-quality clinical and regulatory documents supporting global clinical development programs.
The successful candidate will collaborate with Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance, Regulatory Affairs, and external partners to develop scientifically accurate, regulatory-compliant, and inspection-ready documentation.
This is an excellent opportunity for experienced professionals looking for medical writer jobs in Ahmedabad, clinical development jobs, pharmaceutical writing roles, or regulatory medical writing opportunities.
Key Responsibilities
- Author and compile clinical trial and regulatory documents.
- Develop Clinical Study Protocols and Protocol Amendments.
- Prepare and review Investigator’s Brochures (IBs).
- Author and manage Clinical Study Reports (CSRs).
- Support development of Informed Consent Forms (ICFs).
- Prepare Statistical Analysis Plan summaries.
- Develop clinical sections of regulatory submissions.
- Prepare Investigator Meeting materials and clinical study manuals.
- Support preparation of safety narratives and development reports.
- Ensure scientific accuracy and consistency across clinical documents.
- Maintain compliance with ICH-GCP, FDA, EMA, and applicable regulatory requirements.
- Collaborate with cross-functional teams to interpret and present clinical data.
- Manage document review cycles and stakeholder feedback.
- Maintain document version control and document management systems.
- Support health authority submissions and regulatory responses.
- Develop and maintain document templates, style guides, and writing standards.
Required Qualifications
Candidates applying for this Medical Writer job at Amneal should have:
- Bachelor’s Degree in a Science field.
- Advanced degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related fields preferred.
- Master’s Degree, Pharm.D, or MD candidates may be preferred.
- 5+ years of experience in Regulatory Affairs, Technical Writing, Pharmaceutical Industry, or related fields.
- Strong experience in clinical research and drug development.
- Knowledge of clinical trials and regulatory documentation.
- Understanding of ICH Guidelines and ICH-GCP.
- Strong scientific and technical writing skills.
- Excellent analytical and communication skills.
- Experience collaborating with cross-functional teams.
Required Skills
- Medical Writing
- Technical Writing
- Clinical Research
- Clinical Trials
- Drug Development
- Regulatory Requirements
- ICH Guidelines
- Pharmacovigilance
- Biostatistics
- Analytical Skills
- Style Guides
- Detail Orientation
- Interpersonal Communication
- Regulatory Documentation
Why Consider a Career at Amneal?
Working in Clinical Affairs or Medical Writing provides exposure to the complete clinical development and regulatory lifecycle.
These roles offer opportunities to work with:
- Global clinical development teams.
- Clinical research and drug development programs.
- Regulatory authorities and submission processes.
- Clinical Operations and Medical Affairs teams.
- Pharmacovigilance and safety reporting teams.
- CROs, clinical sites, laboratories, and external vendors.
- TMF, CTMS, EDC, and clinical trial technologies.
- Digital and AI/ML-enabled clinical trial operations.
Who Should Apply?
These Amneal jobs in Ahmedabad are suitable for experienced professionals with backgrounds in:
- Clinical Research
- Clinical Operations
- Clinical Affairs
- Medical Writing
- Regulatory Affairs
- Pharmacovigilance
- Pharmaceutical Sciences
- Life Sciences
- Pharm.D
- Pharmacy
- Biotechnology
- Drug Development
Candidates with strong knowledge of clinical trials, GCP, ICH guidelines, regulatory submissions, scientific writing, and clinical documentation are encouraged to apply.
Job Location
Both positions are based in Ahmedabad, Gujarat, India.
Amneal Location:
Shapath-V, Near Hotel Crowne Plaza, Ahmedabad, Gujarat โ 380015, India
Salary and Compensation
Salary is expected to be competitive and will depend on the candidate’s experience, qualifications, technical expertise, and relevant industry background.
Estimated salary range:
- Senior Executive, Clinical Affairs: โน8โ15 LPA
- Medical Writer, Clinical Development: โน7โ14 LPA
Note: The salary ranges above are estimated market-based ranges and have not been officially disclosed by Amneal.
How to Apply
Application Link For Senior Executive, Clinical Affairs
Application Link For Executive, Clinical Affairs โ Medical Writer, Clinical Development