Insignia Clinical Services is hiring experienced Medical Writers in Delhi for its clinical research operations. This is a full-time, office-based opportunity for professionals with experience in medical writing, clinical research documentation, protocol development, literature review, Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), and other clinical study documents.

Candidates with postgraduate qualifications in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related disciplines can apply. Relevant medical writing experience within a CRO, pharmaceutical company, clinical research organization, or BA/BE study centre is preferred.

This Medical Writer job in Delhi is particularly relevant for candidates with strong scientific writing capabilities and a good understanding of clinical research regulations, including ICH-GCP and applicable regulatory guidelines.

Key Responsibilities

Selected Medical Writers will be responsible for developing, reviewing, and maintaining scientific and clinical research documentation throughout the clinical study lifecycle.

• Conduct comprehensive literature reviews to support clinical study documentation.
• Draft and review Phase I, Phase II, Phase III, and Phase IV clinical study protocols for drugs, vaccines, and other clinical research projects.
• Prepare and maintain Study Protocols, Informed Consent Forms (ICFs), Investigator’s Brochures (IBs), Case Report Forms (CRFs), Patient Information Sheets, Study Manuals, and other essential documents.
• Prepare protocol amendments and update clinical study documentation when required.
• Coordinate with Clinical Operations, Pharmacokinetics, Biostatistics, Clinical Data Management, Quality Assurance, Regulatory Affairs, Investigators, Sponsors, and Project Management teams.
• Collect cross-functional inputs and incorporate them into finalized study documents.
• Organize and participate in protocol review meetings.
• Support Clinical Data Management teams in CRF design and review.
• Prepare scientific abstracts, manuscripts, presentations, posters, and slide decks for conferences and scientific meetings.
• Ensure clinical documents comply with ICH-GCP, CDSCO, WHO, sponsor requirements, and applicable regulatory guidelines.
• Maintain document accuracy, consistency, version control, quality, and timely delivery.

Qualifications

Applicants should possess a postgraduate degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related scientific discipline.

Relevant degrees may include qualifications such as M.Pharm, M.Sc Life Sciences, M.Sc Biotechnology, postgraduate Clinical Research qualifications, and other related postgraduate life-science degrees, subject to the employer’s screening criteria.

Relevant experience in Medical Writing within a CRO, BA/BE study centre, pharmaceutical company, or clinical research environment is preferred.

Skills Required

Candidates applying for the Insignia Clinical Services Medical Writer position should have:

• Strong scientific and medical writing skills
• Literature searching and literature review capabilities
• Understanding of clinical research and study documentation
• Knowledge of ICH-GCP guidelines
• Clinical study protocol writing and review skills
• Understanding of ICFs, IBs and CRFs
• Proficiency in Microsoft Office
• Excellent written and verbal communication
• Strong attention to detail
• Time-management and organizational abilities
• Ability to collaborate with multidisciplinary clinical research teams

Who Can Apply?

Postgraduates from Pharmacy, Life Sciences, Biotechnology, Clinical Research, and related scientific disciplines with relevant medical writing or clinical research documentation experience can apply.

Professionals who have previously worked in a CRO or BA/BE study centre may have an additional advantage during the selection process.

Why Consider This Medical Writer Opportunity?

This Medical Writer role provides exposure to a broad range of clinical research documentation, including protocols across Phase I-IV clinical studies, informed consent documents, Investigator’s Brochures, CRFs, manuscripts, abstracts, and other scientific materials.

The position also involves collaboration with Clinical Operations, Pharmacokinetics, Biostatistics, Data Management, QA, Regulatory Affairs, investigators, sponsors, and project management teams. This cross-functional exposure can be valuable for professionals building a long-term career in medical and scientific writing.

Job Benefits

The employer announcement does not specify a detailed benefits package. However, the position offers professional exposure to clinical research documentation, multidisciplinary study teams, scientific communication, regulatory requirements, and different phases of clinical development.

Salary and employment benefits will depend on the candidate’s experience, skills, current compensation, and the company’s employment policies.

How to Apply

Interested and eligible candidates can send their updated CV/resume directly to:

Email: careers@insigniacs.com