Medical Writer

Job Title:

Medical Writer

Business Unit:

MACR

Location:

Mumbai

“Create your own sunshine”

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.”

JOB SUMMERY:

A Team member of the Trademark department contributes to the execution of trademark-related tasks under the supervision of the Head of Trademark and the Lead Trademark. This role involves supporting brand clearance, prosecution, new brand registration, trademark renewal, litigation, and domain name misuse activities. The team member plays a proactive role during outdoor seizure operations in case of misuse of a brand logo by Infringer.

YOUR TASKS AND 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

1. Clinical Study Protocol
2. Clinical Study Report3. Inform Consent Document4. Abstract Preparation5. Manuscripts - Reviewing & Writing6. Publications and Index Medical Journals7. Research Article, Review Article and Meta Analysis8. Overall Project and Budget Management

WHO YOU ARE:

• Preferably Pharmacy post-graduate /graduate
• 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

Job Requirements

Educational Qualification

Bachelor's or Master's degree in a field related to Science, Healthcare, Clinical Research or Life Sciences like Biology, Pharmacology, Nursing, or a related discipline, and/or Post-graduate in Clinical Research.

Experience

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

PHYSICAL REQUIREMENTS/WORKING CONDITIONS

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