Amneal Recruitment 2026 offers an opportunity for experienced professionals to join its Clinical Affairs function as an Executive – Clinical Affairs (Medical Writer, Clinical Development) in Ahmedabad, Gujarat. The role focuses on preparing, reviewing and managing clinical and regulatory documents that support global clinical development programs.
The selected candidate will work closely with teams including Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance and Regulatory Affairs, as well as external partners. The position requires strong scientific writing capabilities, clinical research knowledge and an understanding of regulatory requirements.
This opportunity may be suitable for candidates with a scientific or pharmaceutical background and professional experience in medical writing, regulatory affairs, technical writing or the pharmaceutical industry.
Amneal Recruitment 2026 – Job Highlights
| Particulars | Details |
|---|---|
| Company | Amneal |
| Job Title | Executive – Clinical Affairs |
| Role | Medical Writer, Clinical Development |
| Job Identification | 8945 |
| Job Category | Technical / Medical Writing |
| Location | Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015 |
| Job Type | Full Time |
| Required Qualification | Bachelor’s Degree in Science |
| Preferred Background | Master’s / PharmD / MD or advanced degree in relevant field |
| Experience | 5+ years in Regulatory Affairs, Technical Writing, Pharmaceutical Industry or related field |
| Medical Writing Experience | 3+ years mentioned in role requirements |
| Key Areas | Clinical Research, Medical Writing, Regulatory Documentation |
| Salary / CTC | Not Specified |
About Amneal
Amneal is a pharmaceutical company committed to developing and delivering healthcare solutions while maintaining a diverse and inclusive workplace.
The company states that it is an equal opportunity employer and aims to create a work environment where employees from different backgrounds and experiences can contribute and grow.
Job Description
The Executive – Clinical Affairs (Medical Writer, Clinical Development) will be responsible for authoring, reviewing and managing clinical and regulatory documents used throughout global clinical development programs.
The role requires the ability to understand scientific and clinical information, convert complex data into clear documentation and ensure that deliverables meet applicable quality and regulatory standards.
The Medical Writer will collaborate with multiple internal functions and external partners to support clinical trial documentation and global regulatory submissions.
Role: Medical Writer – Clinical Development
The Medical Writer will contribute to clinical development programs by preparing a range of documents used in clinical research and regulatory activities.
The role combines scientific writing, document management, cross-functional coordination and regulatory compliance.
Key Responsibilities
Clinical and Regulatory Document Writing
The selected candidate will be responsible for authoring and compiling documents such as:
- Clinical Study Protocols and protocol amendments.
- Investigator’s Brochures (IBs).
- Clinical Study Reports (CSRs).
- Informed Consent Forms (ICFs).
- Statistical Analysis Plan summaries.
- Clinical sections of regulatory submissions.
- Investigator Meeting materials.
- Study manuals and related clinical documents.
- Safety narratives.
- Clinical development reports.
Scientific and Regulatory Review
- Ensure clinical documents are scientifically accurate and consistent.
- Review documents for compliance with applicable regulatory requirements.
- Apply relevant ICH-GCP principles to clinical documentation.
- Consider requirements applicable to agencies such as the FDA and EMA.
- Maintain documentation standards required for regulatory and inspection purposes.
- Support the preparation of high-quality documents for global clinical development programs.
Cross-Functional Collaboration
- Work with Clinical Operations to gather relevant clinical information.
- Collaborate with Medical Affairs and Biometrics teams.
- Coordinate with Pharmacovigilance and Regulatory Affairs functions.
- Work with external partners involved in document development.
- Gather, interpret and present clinical data appropriately.
- Coordinate stakeholder input during document development and review.
Document Review and Management
- Manage document review cycles.
- Collect and incorporate comments from relevant stakeholders.
- Maintain document version control.
- Track revisions and ensure appropriate updates are incorporated.
- Help maintain consistent formatting and writing standards across documents.
Regulatory Submission Support
- Support preparation of clinical documentation for health authority submissions.
- Assist with responses to regulatory queries.
- Contribute to documentation required for global regulatory activities.
- Ensure relevant clinical content is presented accurately and clearly.
Writing Standards and Templates
- Develop and maintain document templates.
- Support creation and maintenance of style guides.
- Help establish consistent medical and technical writing standards.
- Promote consistency across clinical and regulatory documents.
Educational Qualification
The vacancy specifies the following educational requirements:
Required Qualification
- Bachelor’s Degree (BA/BS) in a Science field.
Preferred Qualification
The role description indicates that an advanced degree in a relevant discipline is preferred, such as:
- Master’s degree in Life Sciences or a related field.
- Pharmacy.
- PharmD.
- Medicine / MD.
- Biotechnology.
- Other relevant scientific disciplines.
Experience Required
The vacancy information contains two related experience requirements:
- 3+ years of medical writing experience in the pharmaceutical, biotechnology or CRO industry is stated in the role requirements.
- The job qualification section specifies 5 years or more of experience working with Regulatory Affairs, Technical Writing, the Pharmaceutical industry or a related field.
Candidates should therefore carefully review the employer’s current application requirements and ensure their experience aligns with the position.
Technical Knowledge and Skills
Candidates should have a strong understanding of areas relevant to clinical and medical writing, including:
- Clinical research.
- Clinical trials.
- Drug development.
- Pre-clinical development.
- ICH guidelines.
- Regulatory requirements.
- Pharmacovigilance.
- Biostatistics.
- Medical devices.
- Biologics License Applications (BLA).
- Scientific and technical writing.
- Style guides and document standards.
- Analytical skills.
- Clinical development documentation.
Key Competencies
The position requires both technical expertise and professional collaboration skills.
Important competencies include:
- Strong scientific writing ability.
- Excellent attention to detail.
- Scientific rigor.
- Strong analytical capabilities.
- Effective interpersonal and communication skills.
- Cross-functional collaboration.
- Project management ability.
- Ability to manage multiple projects and deadlines.
- Strong document organization and version-control practices.
- Commitment to quality and regulatory compliance.
- Ability to work effectively with different stakeholders.
- Focus on operational excellence.
Key Success Indicator
The primary success measure for this role is the ability to deliver accurate, high-quality and regulatory-compliant clinical documentation that supports efficient clinical trial execution and successful global regulatory submissions.
Work Location and Job Schedule
The position is based at:
Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015, India
- Job Category: Technical / Medical Writing
- Job Schedule: Full Time
- Work Location: Ahmedabad, Gujarat
- The vacancy information does not specify whether the position is remote, hybrid or fully office-based.
Salary / CTC
Amneal has not specified the salary or CTC for the Executive – Clinical Affairs (Medical Writer, Clinical Development) position in the provided vacancy details.
Candidates should refer to the official recruitment communication for compensation and other employment terms.
Selection Process
The detailed selection process has not been mentioned in the provided job information.
Candidates should follow the company’s official recruitment process. The hiring process may assess relevant educational qualifications, medical writing experience, clinical research knowledge, regulatory understanding, scientific writing skills and other role-specific competencies.
How to Apply
Interested and eligible candidates should apply through the official Amneal recruitment process for Job Identification 8945 – Executive, Clinical Affairs.
Before applying, candidates should:
- Review the educational requirements.
- Check their relevant experience in medical writing, regulatory affairs or the pharmaceutical industry.
- Highlight experience with clinical and regulatory documents on their resume.
- Mention relevant knowledge of clinical research, drug development, ICH guidelines and regulatory requirements.
- Highlight experience with medical writing, technical writing or clinical development documentation.
- Submit accurate professional and educational details through the official application channel.
Important Details Before Applying
- Company: Amneal
- Position: Executive – Clinical Affairs
- Role: Medical Writer, Clinical Development
- Job ID: 8945
- Job Category: Technical / Medical Writing
- Location: Ahmedabad, Gujarat
- Job Type: Full Time
- Required Degree: Bachelor’s Degree in Science
- Preferred Education: Advanced degree in a relevant scientific field, including Master’s, PharmD or MD
- Medical Writing Experience: 3+ years stated in the role requirements
- Overall Experience: 5+ years in Regulatory Affairs, Technical Writing, Pharmaceutical Industry or related field stated in the qualification section
- Key Knowledge: Clinical research, clinical trials, drug development, ICH guidelines and regulatory requirements
- Regulatory Exposure: FDA, EMA and other applicable regulatory requirements
- Salary: Not specified
Important Note
The experience requirements in the vacancy information include both 3+ years of medical writing experience and 5+ years of experience in Regulatory Affairs, Technical Writing, Pharmaceutical Industry or a related field. Candidates should review the official job posting carefully to determine whether their background meets the employer’s current requirements.
Job status, eligibility criteria, application conditions and other recruitment details may change. Candidates are advised to verify the latest information through the official Amneal recruitment source before applying.
FAQs – Amneal Executive Clinical Affairs Recruitment 2026
1. What position is Amneal hiring for?
Amneal is hiring for Executive – Clinical Affairs, with the role described as Medical Writer, Clinical Development.
2. What is the Job ID?
The Job Identification number is 8945.
3. Where is this Medical Writer position located?
The position is based at Shapath-V, Near Hotel Crown Plaza, Ahmedabad, Gujarat – 380015.
4. What educational qualification is required?
A Bachelor’s Degree (BA/BS) in a Science field is listed as required. An advanced degree such as a Master’s, PharmD or MD in a relevant field is preferred.
5. How much experience is required?
The role description mentions 3+ years of medical writing experience, while the qualification section specifies 5 years or more of experience in Regulatory Affairs, Technical Writing, Pharmaceutical Industry or a related field.
6. What documents will the Medical Writer prepare?
The role includes preparation of clinical protocols, protocol amendments, Investigator’s Brochures, Clinical Study Reports, Informed Consent Forms, regulatory submission sections, safety narratives, study manuals and other clinical development documents.
7. Does the position involve regulatory submissions?
Yes. The Medical Writer will support clinical documentation for health authority submissions and responses to regulatory queries.
8. Which regulatory guidelines are relevant to this role?
The position requires an understanding of ICH-GCP, FDA, EMA and other applicable regulatory requirements.
9. What skills are important for the Medical Writer role?
Important skills include scientific and technical writing, analytical ability, attention to detail, clinical research knowledge, regulatory understanding, communication, project management and cross-functional collaboration.
10. Is the Amneal position full time?
Yes. The job schedule is listed as Full Time.
11. Has Amneal mentioned the salary?
No specific salary or CTC has been provided in the vacancy details.
This article is ready for publication and keeps the 3+ years medical-writing requirement and 5+ years overall experience requirement clearly separated, rather than incorrectly presenting them as the same criterion.