Executive, Clinical Affairs

Job Description

Position Title: Medical Writer, Clinical Development

Role Summary

The Medical Writer will be responsible for authoring, reviewing, and managing high-quality clinical and regulatory documents to support global clinical development programs. The individual will work closely with Clinical Operations, Medical Affairs, Biometrics, Pharmacovigilance, Regulatory Affairs, and external partners to ensure scientifically accurate, regulatory-compliant, and inspection-ready documentation.

Key Responsibilities

Author and compile clinical trial documents, including:Clinical Study Protocols and AmendmentsInvestigator's Brochures (IBs)Clinical Study Reports (CSRs)Informed Consent Forms (ICFs)Statistical Analysis Plan summariesClinical sections of regulatory submissionsInvestigator Meeting materials and study manualsSafety narratives and development reportsEnsure consistency, scientific accuracy, and compliance with ICH-GCP, FDA, EMA, and other applicable regulatory requirements.Collaborate with cross-functional teams to gather, interpret, and present clinical data effectively.Manage document review cycles, incorporate stakeholder feedback, and maintain version control.Support health authority submissions and responses to regulatory queries.Develop and maintain document templates, style guides, and writing standards.

Qualifications

Advanced degree in Life Sciences, Pharmacy, Medicine, Biotechnology, or related field (Master's/PharmD/MD preferred).3+ years of medical writing experience in the pharmaceutical, biotechnology, or CRO industry.Strong understanding of clinical research, drug development, ICH-GCP, and regulatory guidelines.Excellent scientific writing, communication, and project management skills.Proficiency with Microsoft Office and document management systems.

Desired Competencies

Scientific rigor and attention to detail.Strong cross-functional collaboration.Ability to manage multiple projects and timelines.Commitment to quality, compliance, and operational excellence.

Key Success Indicator

Deliver accurate, high-quality, regulatory-compliant clinical documents that enable efficient execution of clinical trials and successful global regulatory submissions.

Education

QUALIFICATIONS

Bachelors Degree (BA/BS) Science field - Required

Experience:

5 years or more in Working with Regulatory Affairs, Technical Writing, Pharmaceutical industry or related field.

Specialized Knowledge: Licenses:

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.