Medical Writer

Job Title:

Medical Writer

Business Unit:

Clinical Research

Location:

Sun House, Mumbai

At Sun Pharma, we commit to helping you "Create your own sunshine"— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."

Key responsibilities:

• Develop and update process documents, SOPs and trackers for Medical Writing Function
• Prepare, review and edit clinical trial protocols, investigator's brochure (IB), Case Report Form (CRF), Informed Consent Document (ICD) and Patient diaries (if applicable) 
• Prepare, review and edit Clinical Study Report (CSR), executive summary and study-specific logs
• Ensure all study documents like protocol, ICD, CRF, patient diaries & CSRs are prepared in alignment with ICH-GCP, CDSCO guidelines and all applicable regulatory guidelines
• Conduct quality check (QC) of protocols, protocol amendments, CRF, ICD, CSR and other relevant documents
• Lead review cycles of documents with respective stakeholders for timely completion
• Finalize publication plan for each manuscript in coordination with respective medical affairs personnel
• Prepare and review manuscripts – original research articles, review articles, meta-analyses, consensus / expert opinion, abstracts, posters and other relevant documents, in alignment with IJCME, GPP3 and any other relevant guidelines
• Work cohesively with internal stakeholders including Clinical research team, Medical Affairs team, business team, regulatory affairs, legal team, compliance team and project specific other functions
• Strong coordination with external stakeholders including investigators, Key Opinion Leader (KOL) authors, Biostatisticians, Data management team & medical association office bearers
• Vendor management for Medical writing vendors, in accordance with Sun Pharma policies and procedures
• Ensure execution of MSAs, project contracts, and invoice management

Job Requirements

Educational Qualification

MBBS

Experience

3-5 years' experience in a CRO/Pharma/Biotech organization in Medical Writing for interventional and non-interventional studies

Additional Skills:

• Formal training in Medical Writing will be value add
• Well versed with IJCME, GPP3, STROBE, CONSORT, STARD, CARE guidelines and PRISMA statement
• Experience of medical writing for complex publications (e.g. Meta-analysis, consensus, guidelines) with successful outcome will be of added advantage
• Experience in publications in indexed journals
• Training in clinical trial methodologies, research design and ICH – GCP & publication guidelines
• Relevant knowledge of Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals
• Strong academic record with knowledge of research methodologies & publication processes for different type of publications

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).