Medical Writer

Sun Pharmaceutical Industries Ltd; Mumbai; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd in Mumbai seeks a Medical Writer to support trademark-related tasks and lead publication writing in alignment with ICH-GCP and regulatory guidelines.

You will develop SOPs, prepare clinical study documents, manuscripts and abstracts, and coordinate with internal teams and external investigators to ensure high-quality publications and compliance.

Qualifications

• 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-analyses, 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.

Responsibilities

• Develop and update process documents, SOPs and trackers for Medical Writing Function.
• Prepare, review and edit clinical trial protocols, investigator’s brochure, Case Report Form, Informed Consent Document and Patient diaries (if applicable).
• Prepare, review and edit Clinical Study Report, executive summary and study-specific logs.
• Ensure all study documents are prepared in alignment with ICH-GCP, CDSCO guidelines and applicable regulatory guidelines.
• Conduct QC of protocols, protocol amendments, CRF, ICD, CSR and other documents; lead review cycles with stakeholders for timely completion.
• Finalize publication plan for each manuscript in coordination with medical affairs personnel.
• Prepare and review manuscripts – original research articles, review articles, meta-analyses, consensus/opinion, abstracts, posters.
• Collaborate with Clinical Research, Medical Affairs, Regulatory, Legal, Compliance and other functions.
• Coordinate with external stakeholders including investigators, KOLs, biostatisticians and data management.
• Vendor management for Medical writing vendors; ensure MSAs, project contracts and invoice management.
• Oversee overall project and budget management.

Skills

Medical Writing

Publication Knowledge

Stakeholder Coordination

ICH-GCP Knowledge

Education

Bachelor's or Master's in Life Sciences

Post-graduate in Clinical Research

Job description

Job Title:

Medical Writer

Business Unit:

MACR

Location:

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.”

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. 1. Clinical Study Protocol
2. 2. Clinical Study Report
3. 3. Inform Consent Document
4. 4. Abstract Preparation
5. 5. Manuscripts - Reviewing & Writing
6. 6. Publications and Index Medical Journals
7. 7. Research Article, Review Article and Meta Analysis
8. 8. 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).