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 Are You Ready to Create Your Own Sunshine 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