As a Medical Writer in Clinical Research, your primary responsibility will be to produce high-quality written content for various clinical research documents such as Protocol, Investigator Brochure, Clinical Study Report and Publications. You will work closely with clinical research teams, physicians, scientists, and regulatory affairs personnel to develop, review, and edit documents that support clinical trials, regulatory submissions, and scientific publications. Your role will involve synthesizing complex medical and scientific information into clear and concise language for diverse audiences.

Key Responsibilities:

Document Development:

• Prepare clinical study protocols, investigator brochures, clinical study reports, and other study-related documents in accordance with Indian and international guidelines (Indian/ICH-GCP, New Clinical Trial Rules-2019).
• Collaborate with cross-functional teams to gather and analyze clinical data, ensuring accuracy and completeness.
• Develop or contribute to the development of clinical sections of regulatory submission documents.

Scientific Writing:

• Write and edit scientific manuscripts, abstracts, posters, and presentations for conferences, scientific journals, and internal/external stakeholders.
• Communicate complex clinical and scientific concepts in a clear, concise, and engaging manner, tailoring the content to target audiences (e.g., healthcare professionals, regulatory authorities).

Literature Review:

• Conduct comprehensive literature reviews to gather relevant data and information to support clinical research projects.
• Stay updated with current literature and scientific advancements in relevant therapeutic areas, ensuring accurate referencing and incorporation of relevant data into documents.

Regulatory Compliance:

• Ensure adherence to applicable regulations, guidelines, and industry best practices (e.g., International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [ICH], Good Clinical Practice [GCP]) in all written materials.
• Collaborate with regulatory affairs teams to address queries or requests for additional information during the regulatory submission process.

Collaboration and Coordination:

• Collaborate with cross-functional teams, including clinical scientists, statisticians, and data managers, to ensure accuracy and consistency of information presented in documents.
• Participate in internal and external meetings, providing medical writing expertise, and contributing to project planning and strategy discussions.

Qualifications and Skills:

• A bachelor's degree in a scientific discipline (e.g., life sciences, pharmacy, medicine) is typically required. Advanced degrees (e.g., MSc, PhD, PharmD) are highly advantageous.
• Strong knowledge of clinical research methodologies, biostatistics, and regulatory guidelines (e.g., ICH-GCP) is essential.
• Excellent written and verbal communication skills, with the ability to effectively present complex information in a clear and concise manner.
• Proficiency in scientific and medical writing, including the ability to interpret and summarize clinical data accurately.
• Familiarity with document management systems, publication tools (e.g., EndNote, Reference Manager), and relevant software (e.g., Microsoft Office, Adobe Acrobat).
• Attention to detail, critical thinking abilities, and the ability to work independently and meet tight deadlines.
• Familiarity with therapeutic areas, clinical trial design, and drug development processes is desirable.
• Prior experience in medical writing for clinical research in the pharmaceutical, biotechnology, or contract research organization (CRO) industry is preferred.

Patanjali Research Foundation is an equal opportunity employer and does not discriminate against any applicant because of race, colour, religion, gender, national origin, age and physical disability.

How to Apply

• Write to jobs@patanjali.res.in with your detailed CV and career aspirations.
• Mention Medical Writer, citing respective Job Code.
• List three professional references other than your friends and family.