We are currently seeking a Medical Writer based in Mumbai for one of the leading Pharmaceutical, a role that offers an exciting opportunity to contribute to the creation of high-quality, scientifically accurate medical documents, including clinical study reports, regulatory submissions, and educational materials.

Please find below a brief overview of the role:

Job Title: Medical Writer

Location: Mumbai

Company: Wockhardt Pharma

Job Overview:

As a Medical Writer you will be responsible for creating high-quality, scientifically accurate medical documents, including clinical study reports, regulatory submissions, publications, and educational materials. This role demands adherence to relevant guidelines and standards, along with a deep understanding of the therapeutic areas and products within the Wockhardt portfolio.

Key Responsibilities:

Document Development:

- Draft and revise clinical study reports (CSRs), protocols, Investigator Brochures, and safety narratives.

- Write and edit scientific manuscripts for peer-reviewed journals.

- Develop patient information materials and healthcare professional educational content.

- Prepare presentations and summaries of clinical data for internal and external stakeholders.

Data Analysis and Interpretation:

- Analyze clinical trial data to identify key findings and translate them into clear, concise reports.

- Interpret complex scientific information to ensure accurate representation in medical documents.

- Collaborate with clinical research teams to understand study designs and objectives.

Compliance and Quality Assurance:

- Adhere to regulatory guidelines (ICH, FDA, etc.) and internal SOPs for medical writing.

- Review and edit documents thoroughly for accuracy, consistency, and clarity.

- Deliver high-quality documents within project timelines.

Therapeutic Area Expertise:

- Develop and maintain expertise in assigned therapeutic areas, including disease states and treatment options.

- Stay updated on scientific advancements and regulatory requirements.

Required Skills and Qualifications:

Education:

Ph.D. in Pharmacology, Clinical Research, Life Sciences, or a related field is preferred.

Experience:

2- 5 years of medical writing experience in the pharmaceutical industry, with a focus on regulatory submissions.