Clinical Research Medical Writer

Founded in 2015, Healthark began as a healthcare and life sciences consulting firm and is rapidly transforming into a tech-first organization specializing in Data Engineering, Data Science, Analytics, Generative AI, and Intelligent Automation.

We are a cross-disciplinary team that fuses deep healthcare domain expertise with cutting-edge technological capabilities to tackle complex, data-driven challenges across the healthcare ecosystem. Our services span Growth and GCC Advisory, Real-World Evidence (RWE), digital health innovation, AI/ML solutioning, and the development of modern data platforms.

With a team of 150+ consultants, data scientists, engineers, and healthcare experts, we have delivered over 1000 high-impact projects across 60+ global markets. Our clientele includes nimble startups as well as global healthcare and life sciences leaders.

From our innovation hubs in Ahmedabad, Bangalore, and Hyderabad, Healthark is driving the next wave of healthcare transformation—leveraging scalable data platforms, automation frameworks, and GenAI-powered insights to deliver measurable outcomes.

**Position**:Clinical Research Medical Writer

**Experience**:6 to 10 yrs

**Location**:Hyderabad (Mon-Fri)

Position Overview:
Key Responsibilities
- Draft and revise Study Design, Clinical Trial Protocols, Informed Consent Forms (ICFs), Case Report Forms (CRFs), Clinical Study Reports (CSRs), and Investigator Brochures (IBs) in accordance with ICH-GCP guidelines and other regulatory requirements (e.g., CDSCO, ICMR, FDA, EMA)
- Develop content for scientific abstracts, posters, and manuscripts for peer-reviewed journals and international conferences.
- Conduct literature reviews and summarize key findings relevant to ongoing and upcoming studies.
- Reviewing Statistical Analysis Plans (SAPs) to ensure alignment with study objectives, protocols, and regulatory requirements
- Review and interpret statistical outputs to accurately present efficacy and safety data in clinical documents
- Assist in the preparation of responses to regulatory bodies or ethics committees as needed.
- Support regulatory writer for preparing documentation required for regulatory submissions
- Ensure all documents meet internal quality standards and adhere to regulatory, journal, and company guidelines.
- Collaborate with clinical, data management, regulatory, and quality teams to ensure alignment on study deliverables.
- Collaborate with the Germany team and support global clinical trials and documentation efforts
- Maintain high standards of scientific integrity, accuracy, and compliance in all documentation.
- Track document timelines and ensure timely submissions across deliverables.

**Requirements**:

- Master’s degree or equivalent in Life Sciences, Clinical Research, Public Health,

Epidemiology, Pharmacy, or related field.
- Minimum **6-10 years**of experience in study design and clinical trial documentation within the pharmaceutical, CRO or clinical research setting.
- Prior experience in drafting clinical trial documents and publishing in peer-reviewed journals is essential.
- Must have proven experience in authoring scientific publications in reputable journals, as well as contributing to scientific abstracts presented at renowned international conferences.
- Must have experience in preparing figures and graphs for scientific publications and conference abstracts.
- Proficiency in statistical analysis, with a preferred background in epidemiology or biostatistics

**Skills**:

- Excellent written and verbal communication skills
- Familiarity with data analytics tools, including **PowerPoint, GraphPad Prism, SPSS,**

and **Adobe software.**
- Ability to review and comprehend research papers and provide concise literature summaries to the senior team.
- Ability to manage multiple projects simultaneously and adapt to evolving priorities.
- Comfortable working independently and in cross-functional teams.

Pay: ₹300,000.00 - ₹1,000,000.00 per year

**Education**:

- Master's (preferred)

**Experience**:

- medical writing: 6 years (required)

**Location**:

- Hyderabad, Telangana (required)

Work Location: In person