684 Clinical Data Management jobs in India

**JOIN AMGEN'S MISSION OF SERVING PATIENTS**
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
**Associate Vice President, Clinical Data Management**
**Live**
**What you will do**
Let's do this. Let's change the world. The Associate Vice President, Clinical Data Management is a member of the Global Development Operations (GDO) leadership team and is a strategic partner to the R&D organization.
**The AVP will lead Amgen's Clinical Data Management function within GDO, ensuring the highest quality of clinical data collection, processing, and analysis to support regulatory submissions and clinical development programs. This role is responsible for the strategic direction, leadership, and operational oversight of data management processes supporting clinical trials across all therapeutic areas and phases.**
This AVP will collaborate closely with cross-functional teams including clinical operations, biostatistics, regulatory affairs, and quality to drive data integrity and compliance with global regulatory standards.
The role requires a visionary leader with deep expertise in CDM and a proven ability to scale and lead global teams in a complex matrix environment.
**Responsibilities:**
+ **Develop and drive the global data management strategy in alignment with clinical development objectives and corporate goals.**
+ **Provide strategic and operational leadership to the Clinical Data Management (CDM) function across all clinical programs and phases.**
+ **Lead innovation initiatives, including the implementation of development integration programs and the adoption of cutting-edge technologies to enhance data workflows.**
+ Represent Clinical Data Management in executive leadership discussions, regulatory interactions, and industry forums.
+ Establish and enforce robust clinical data governance models, policies, and risk mitigation strategies to ensure quality and compliance.
+ **Make final decisions regarding standard operating procedures (SOPs), CDM best practices, and process optimization.**
+ Engage key stakeholders and ensure timely resolution on critical data integrity and regulatory compliance issues.
+ Serve as the primary CDM representative during regulatory inspections and audits, with responsibility for final decisions on findings, responses, and corrective actions.
+ Influence cross-functional clinical development, operational, and regulatory strategies through data-driven insights and analytics.
+ Partner closely with Clinical Program Operations, Regulatory, Biostatistics, and R&D to ensure seamless integration and alignment of clinical data.
+ Build and maintain strategic relationships with CROs, vendors, regulatory authorities, and industry organizations to advance CDM excellence.
+ Influence internal leadership and functional partners to promote data-driven decision-making across clinical programs.
+ Lead audit readiness efforts and promote a culture of continuous improvement and compliance within the CDM function.
+ Implement protocols and tools to ensure data security, integrity, and risk management across all platforms and studies.
+ Optimize staffing, outsourcing strategies, and technology investments to improve cost-efficiency, scalability, and delivery timelines.
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The candidate we seek is an experienced leader with the following qualifications.
**Basic Qualifications:**
+ **Bachelor's or master's degree with 25+ years of data management experience AND**
+ **10 to 15 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources**
**Preferred Qualifications:**
+ Experience within clinical data management, regulatory compliance, and strategic leadership within a pharmaceutical, biotech, or CRO environment.
+ **Expertise in GCP, ICH, FDA, EMA regulations, data governance, and clinical trial data standards (CDISC, SDTM).**
+ Experience within cross-functional collaborations, leadership, and strategic planning skills, ensuring operational excellence and compliance while driving innovation in data management to support Amgen's global clinical development efforts.
+ Expertise in AI/ML-driven data management solutions, automation, and advanced analytics.
+ **Understanding of clinical data standards (CDISC, SDTM, ADaM).**
+ **Experience leading regulatory submissions, including NDA/BLA/MAA filings and advisory committee interactions**
+ Proven ability to drive organizational change, optimize processes, and implement lean principles in clinical data management.
+ Cross-functional collaboration experience with clinical operations, regulatory affairs, biostatistics, and R&D teams.
+ **Experience managing FSP relationships and technology implementations (EDC, CTMS, RWD/RWE).**
+ **Knowledge of emerging trends in digital health, data governance, and data privacy regulations (GDPR, HIPAA).**
+ Familiarity with decentralized trial models and digital health technologies.
They will also embody the Amgen leadership attributes which are:
+ **Inspire:** Create a connected, inclusive, and inspiring work environment that empowers talent to thrive
+ **Accelerate:** Enable speed that matches the urgency of patient needs by encouraging progress over perfection
+ **Integrate:** Connect the dots to amplify the collective power of Amgen to drive results for patients, staff, and shareholders
+ **Adapt:** Lead through change by adapting to an ever-changing environment and defining a clear course of action to deliver results
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

·    Perform Migrations / Set up / Close out activities apart from Study Conduct activities under supervision and quality checks

·    Triage of Safety cases

·    Oversight of data discrepancy management

·    Owner of study documentation, including completeness, accuracy, and performing periodic review of eTMF/TMF

·    Responsible for compiling HoS content

·    Conduct the protocol amendment impact assessment and complete appropriate documentation

·    Manage migration and audit trail reports

·    Create slides for study-specific EDC investigator training

·    Generate all study related reports, status updates, and carries out all study related email conversation and communication with internal stakeholders and Client.

·    Provide study specific training to data manager (DM)

·    Contribute to the Data Management Plan (DMP)

·    Request DTS creation and ensure DTS finalized and complete for any LSH loads

·    Execute data review per IDRP (e.g. SAE reconciliation, PK reconciliation, short term-long term reconciliation)

·    Manage table in EDC for study specific inclusion/exclusion data (SDTM related to protocol)

·    Manage global and study-specific data entry conventions

·    Facilitate versioning, including Unlock/audit trail review & Archival process

·    Knowledgeable of study protocol to provide secondary feedback to SD/DWA for consistency and completeness of clinical database/study design

·    Timely communication with key stakeholders on issues and risks, including

o   Brings CDR, DWA, and SD together to discuss post-production changes when identified

·    Provide critical information to PL who will communicate with study team

·    Log any action issues into DS Hub and resolve outstanding issues assigned to DA

·    Mange assigned activities to meet milestone dates

·    Ask questions to get information needed to meet end goals

·    Manage programming only changes (Move to DWA for LSH and SD for EDC when SOP and T11/12 updated)

What you need

·    A Graduate/Post Graduate/Doctorate degree in Life sciences/ Pharmacy/Medical sciences or equivalent degree

·    Minimum 2 years to 6 years of experience in clinical data management

·    Proactively communicate ownership of studies

·    Critical thinking to identify root causes and best solutions for data discrepancy management

·    Confidence to have tough conversations and make challenging decisions

·    Enables an environment of open and honest communication and critical thinking within DSS study team

·    Influence internal team to meet timelines by holding stakeholders accountable

·    Ability to work with different personalities to get the work done

·    Willingness to seek out information to accomplish goal

·    Proactive communication

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Nagpur
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, youll 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 others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Bangalore
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, youll 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 others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Bangalore
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, youll 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 others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Hyderabad
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, youll 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 others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Hyderabad
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, youll 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 others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**Job Title:**
Clinical Research Associate
**Business Unit:**
Clinical Research
**Location:**
Kolkata
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, youll 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 others journeys.
**Key responsibilities:**
+ Perform site feasibility, identify potential investigator, negotiate study budget with potential investigators, finalization of investigators, sites, and execution of CDA and study-related contracts
+ Preparation and submission of study documents for EC permission for respective study across centers
+ Oversee & document IP dispensing, inventory management & reconciliation
+ Ensure timely site initiation, site monitoring, and site close-out activities are performed and respective reports are generated
+ Investigator and site personnel training on the Study protocol, procedures, and GCP principles
+ Ensure timely recruitment of trial participants and subsequent efficient and effective data entry, source data verification and query resolution
+ Ensure timely reporting of SAEs, SUSARs, and reporting of SAEs to all sites and investigators in alignment with regulations and Suns PV policies
+ Risk identification, analysis, and CAPA for sites not meeting expectations as per the plan
+ Co-ordinate with in-house or CRO partners for data management, statistical analysis, statistical analysis report & DBL
**Job Requirements**
**Educational Qualification**
Bachelor's or Masters degree in a health or related field, such as Biology, Chemistry, Nursing, Pharmacy, or Public Health and/or Post-graduate Diploma in Clinical Research
**Experience**
Relevant experience of 1-5 years minimum in the field of Clinical Research.
**Additional Skills:**
+ Knowledge on GCP practices, regulatory guidelines in Clinical Trials
+ Phase III and Phase IV Clinical Trials knowledge expertise
+ Site Management expertise
+ Collaboration with cross functional stakeholders
**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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.

**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, youll 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 others journeys.
**Key responsibilities:**
+ Develop and update process documents, SOPs and trackers for Medical Writing Function
+ Prepare, review and edit clinical trial protocols, investigators 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. Lets 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)._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.