Medical Writer

Sun Pharma; Mumbai; On-site; INR 1,400,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. is seeking a Medical Writer to support the Trademark and Medical Writing functions in Mumbai.

The role involves preparing and updating clinical and regulatory documents, ensuring ICH-GCP compliance, and coordinating publications with medical affairs. Responsibilities include handling protocols, CSR, ICDs, and manuscripts, while liaising with internal teams and external vendors.

Qualifications

• Bachelor's or Master's degree in Science, Healthcare, Clinical Research or Life Sciences.
• Experience in medical writing for interventional and non-interventional studies.
• Familiarity with ICH-GCP, CDSCO guidelines and publication guidelines (e.g., IJCME, GPP3, STROBE, CONSORT).

Responsibilities

• Develop and update SOPs, process documents and trackers for Medical Writing function.
• Prepare, review and edit protocols, IB, CRF, ICD and study diaries.
• Prepare and review CSR, executive summaries and study logs.
• Ensure documents align with ICH-GCP, CDSCO guidelines and regulatory requirements.
• Conduct QC of study documents and lead review cycles with stakeholders.
• Coordinate publication plans with medical affairs and prepare manuscripts for journals and conferences.
• Manage interactions with internal teams and external investigators and vendors.

Skills

Medical writing

Coordination

Vendor management

Regulatory knowledge

Education

Bachelor's or Master's in Science/Healthcare

Tools

MS Office

Job description

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

• Clinical Study Protocol
• Clinical Study Report
• Inform Consent Document
• Abstract Preparation
• Manuscripts - Reviewing & Writing
• Publications and Index Medical Journals
• Research Article, Review Article and Meta Analysis
• 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

The role is majority office based but will involve an average 8 to 10 days of travel outside Mumbai.

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).