Troikaa Pharmaceuticals has announced an opening for a Medical Writer in Ahmedabad for candidates with expertise or academic backgrounds in pharmacology, pharmacokinetics, clinical efficacy studies and scientific writing.
This Medical Writer opportunity is particularly relevant for MD Pharmacology freshers as well as experienced Ph.D, Pharm.D, M.Pharm and M.S. Pharmacology professionals looking to build a career in clinical medical writing, regulatory writing and pharmaceutical research.
The selected Medical Writer will contribute to the preparation and review of clinical study documents, regulatory submission documents and scientific manuscripts while working with clinical development, pharmacovigilance, regulatory affairs, biostatistics, data management and other cross-functional teams.
Who Can Apply?
Candidates should meet one of the following qualification and experience combinations:
- MD (Pharmacology): Freshers can apply
- Ph.D (Pharmacology): 0–2 years of experience
- Pharm.D / M.Pharm / M.S. (Pharmacology): 4–6 years of experience
Candidates who have worked across both pharmacokinetic studies and clinical efficacy studies are preferred.
Medical Writer Responsibilities
The Medical Writer will act as an author or reviewer for a broad range of clinical, scientific and regulatory documents. Major responsibilities include:
- Authoring, reviewing, finalizing and revising Investigator’s Brochures (IB).
- Preparing clinical study synopses and Clinical Study Protocols (CSP).
- Developing and reviewing Informed Consent Documents (ICD) and Participant Diary Cards (PDC).
- Supporting Clinical Outcome Assessment documentation, including PRO, ClinRO, ObsRO and PerfO.
- Developing and reviewing Case Report Forms (CRFs) and CRF completion guidelines.
- Supporting User Acceptance Testing (UAT) for electronic CRFs in collaboration with clinical data management teams.
- Preparing and reviewing Clinical Study Reports (CSR).
- Ensuring consistency, scientific accuracy and regulatory compliance across clinical documents.
- Working in accordance with applicable ICH guidelines, regional regulatory requirements and internal SOPs.
- Supporting document templates, style guides, authoring standards and medical writing process documents.
- Evaluating automation, technology-enabled solutions and AI-assisted medical writing approaches to improve quality and efficiency.
- Preparing clinical components of regulatory submissions, including CTD Modules 2.5 and 2.7.
- Contributing to clinical summaries, clinical overviews, scientific justifications and health authority responses.
- Preparing scientific and regulatory presentation materials, including SEC and investigator meeting slide decks.
- Authoring or reviewing scientific manuscripts developed from clinical study reports.
- Coordinating document reviews and approvals with internal and external stakeholders.
Regulatory & Clinical Documents
Candidates selected for this Medical Writer job may work across several important pharmaceutical documents, including:
IB | CSP | ICD | PDC | COA | PRO | ClinRO | ObsRO | PerfO | CRF | CSR | CTD Modules 2.5 & 2.7 | Clinical Summaries | Clinical Overviews | Scientific Manuscripts | Health Authority Responses
This makes the position particularly relevant to professionals seeking exposure to both clinical medical writing and regulatory medical writing.
Key Skills
Important skills for the Troikaa Pharmaceuticals Medical Writer position include:
Medical Writing, Scientific Writing, Clinical Study Report Writing, Pharmacokinetics, Clinical Efficacy Studies, Clinical Research, Regulatory Writing, ICH Guidelines, Clinical Study Protocols, Investigator Brochures, CTD Documentation, Manuscript Writing, CRF, eCRF UAT and Regulatory Submissions.
Strong scientific interpretation, technical writing, document review and cross-functional communication skills will be valuable for this position.
Cross-Functional Collaboration
The Medical Writer is expected to collaborate with teams across:
- Clinical Development
- Medical Affairs
- Clinical Operations
- Biostatistics
- Clinical Data Management
- Regulatory Affairs
- Pharmacovigilance
- Quality Assurance
- Project Management
This cross-functional exposure can provide valuable experience across the pharmaceutical clinical development lifecycle.
Why Consider This Medical Writer Opportunity?
The role offers exposure to a broad portfolio of clinical and regulatory documentation rather than focusing exclusively on one type of medical writing deliverable.
Professionals joining this role can gain experience in clinical study protocols, investigator brochures, clinical study reports, CTD clinical modules, regulatory submissions and scientific manuscripts.
Another notable aspect of the position is its focus on evaluating automation and AI-assisted approaches for medical writing, which can provide exposure to emerging technology-enabled pharmaceutical documentation workflows.
Salary
For informational purposes, an estimated market range for a Medical Writer with the stated qualification and experience profile in Ahmedabad may be approximately ₹5–12 LPA. Actual compensation may vary significantly depending on qualification, relevant medical writing experience, current compensation and company policy.
How to Apply
