5,256 Pharmaceutical jobs in India

**About this role**
Are you interested in building innovative technology that crafts the financial markets? Do you like working at the speed of a startup, and solving some of the world's most exciting challenges? Do you want to work with, and learn from, hands-on leaders in technology and finance?
At BlackRock, we are looking for Software Engineers who like to innovate and solve sophisticated problems. We recognize that strength comes from diversity, and will embrace your outstanding skills, curiosity, and passion while giving you the opportunity to grow technically and as an individual.
We invest and protect over $9 trillion (USD) of assets and have an extraordinary responsibility to our clients all over the world. Our technology empowers millions of investors to save for retirement, pay for college, buy a home, and improve their financial well-being.
Being a technologist at BlackRock means you get the best of both worlds: working for one of the most sophisticated financial companies and being part of a software development team responsible for next generation technology and solutions.
**What are Aladdin and Aladdin Engineering?**
You will be working on BlackRock's investment operating system called Aladdin. Aladdin is used both internally within BlackRock and externally by many financial institutions. Aladdin combines sophisticated risk analytics with comprehensive portfolio management, trading, and operations tools on a single platform to power informed decision-making and create a connective tissue for thousands of users investing worldwide.
Our Quality Assurance teams reside inside the Aladdin Engineering group. We collaboratively build the next generation of technology that changes the way information, people, and technology intersect for global investment firms. We build and package tools that manage trillions in assets and supports millions of financial instruments. We perform risk calculations and process millions of transactions for thousands of users every day worldwide!
**Being a member of Aladdin Engineering, you will be:**
+ Tenacious: Work in a fast paced and highly complex environment
+ Resourceful problem solver: Analyze multiple solutions and deploy technologies in a flexible way.
+ Great teammate: Think and work collaboratively and communicate effectively.
+ Fast learner: Pick up new concepts and apply them quickly.
**Job Purpose / Background:**
Aladdin Private Markets Quality Engineering is a globally distributed team supporting Quality Engineering initiatives for Apps on Aladdin. The team employs use of industry-leading tools (Selenium, Cypress, Cucumber, Jenkins, Azure dev ops) to support the testing activities. As a QA Engineer you will work as part of the Global testing team supporting Quality Engineering activities for applications on the Aladdin platform.
**Responsibilities include:**
+ Guide and mentor junior team members from both technical and functional standpoint. Foster a culture of continuous improvement and accountability within the team.
+ **Being hands-on and owning functional deliveries.**
+ Apply expertise in Java Script, **Performance Testing** tool **(JMeter)** , or other test frameworks to design, develop and maintain performance test suites.
+ Responsible for managing comprehensive testing phases from planning to execution for functional and non-functional requirements including design, development, and delivery.
+ Work closely with collaborators, customers, partners, and team members to capture client needs, provide design insights, and deliver outstanding work.
+ Analyze and report on QA metrics, trends, and opportunities for improvement, presenting findings to senior management and recommending corrective actions.
+ Champion a culture of quality within the organization, driving awareness and consistency with Quality standards.
+ Prioritize and develop enhancements to continuously improve application stability and scalability.
+ Conduct reviews of applications and workflow processes to target automation effectiveness.
+ Drive a strong culture by bringing principles of inclusion and diversity to the team and setting the tone through specific recruiting, management actions and employee engagement.
**Qualifications:**
+ B.E. / B.Tech. MCA degree in Computer Science, Engineering, or a related subject area or its equivalent
+ 1-3 years of proven experience
**Skills and Experience:**
+ Experience in senior QA role within the financial services industry, ideally in asset management. Deep understanding of investment management processes, risk management methodologies, regulatory compliance requirements or Investment Accounting skills.
+ **Hands on Performance Testing experience (3+ years) using tools like JMeter**
+ Good understanding of performance test frameworks, tools, and scripting languages along with strong analytical and problem-solving skills to address complex issues.
+ Consistent record of successfully leading and implementing QA programs that drive continuous improvement.
+ Comprehensive understanding of software quality assurance and engineering processes, methodologies, and proven methods. Good understanding of Agile software development methodologies.
+ Excellent communication, interpersonal and leadership skills, with the ability to influence and collaborate effectively across diverse teams.
+ Strong foundation in RDBMS, SQL and application infrastructure technologies, performance testing tools & methodologies (JMeter or other), API testing for handling complex distributed systems.
+ Self-motivator, that looks for challenges and rolls up their sleeves to identify and understand the core issues and works closely with all levels and across teams to implement solutions.
**Nice to have and opportunities to learn:**
+ Experience of working in Agile Development Team
+ AZURE Dev Ops, CI/CD integration and associated tools and processes (Jenkins, Maven, SonarQube).
+ AI and Machine Learning (ChatGPT or GitHub CoPilot)
+ Specflow/Cucumber and BDD
+ Cloud based testing.
+ API testing (Postman, Soap UI)
**Our benefits**
To help you stay energized, engaged and inspired, we offer a wide range of benefits including a strong retirement plan, tuition reimbursement, comprehensive healthcare, support for working parents and Flexible Time Off (FTO) so you can relax, recharge and be there for the people you care about.
**Our hybrid work model**
BlackRock's hybrid work model is designed to enable a culture of collaboration and apprenticeship that enriches the experience of our employees, while supporting flexibility for all. Employees are currently required to work at least 4 days in the office per week, with the flexibility to work from home 1 day a week. Some business groups may require more time in the office due to their roles and responsibilities. We remain focused on increasing the impactful moments that arise when we work together in person - aligned with our commitment to performance and innovation. As a new joiner, you can count on this hybrid model to accelerate your learning and onboarding experience here at BlackRock.
**About BlackRock**
At BlackRock, we are all connected by one mission: to help more and more people experience financial well-being. Our clients, and the people they serve, are saving for retirement, paying for their children's educations, buying homes and starting businesses. Their investments also help to strengthen the global economy: support businesses small and large; finance infrastructure projects that connect and power cities; and facilitate innovations that drive progress.
This mission would not be possible without our smartest investment - the one we make in our employees. It's why we're dedicated to creating an environment where our colleagues feel welcomed, valued and supported with networks, benefits and development opportunities to help them thrive.
For additional information on BlackRock, please visit @blackrock ( | Twitter: @blackrock ( | LinkedIn: is proud to be an Equal Opportunity Employer. We evaluate qualified applicants without regard to age, disability, family status, gender identity, race, religion, sex, sexual orientation and other protected attributes at law.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.
**The Position**
**Position Based in Malaysia**
At Roche, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about improving the lives of patients' and are bold in both decision and action. We believe that partnering with health systems around the world can create value for patients, society and for Roche. We are uniquely positioned to realize truly integrated health solutions across pharmaceuticals, diagnostics, digital health and big data solutions; positioning us as a key partner for personalized, sustainable healthcare everywhere.
The Medical Affairs Partner (MAP) demonstrates personal purpose around improving the patient journey, as well as strong passion to create value and impact on the ecosystem. The MAP is a senior level role within the affiliate, who has decision making authority to request resources of Roche (both within the affiliate and broader network) in order to have improved impact on the patient journey.
They are a core member of the disease area pod working in close collaboration with the Patient Journey Partners (PJP). The MAP spends majority of their time in the field close to customers communicating the value of Roche's science and products to physicians, investigators and institutions. They think from an enterprise level, and will also be a member of an APAC level network working across borders, to realize and scale country outcomes by contributing to virtual, cross border, cross functional work package teams.
**The Opportunity:**
The Medical Affairs Partner has a reporting line to the Country Medical, Innovation and Regulatory Lead, serves the affiliate vision with an aligned mindset and behaviors.
+ Oversee the patient journey in its entirety, acts as a system thinker with the ability to identify shared purpose among stakeholders and cocreate with them to bring better outcomes for patients faster by translating insights into strategic and actionable recommendations.
+ Bring the inside out, to bring Roche expertise, science and knowledge to the ecosystem. Steward Roche's products through their lifecycle and supports their appropriate use, which includes sharing their merits with Healthcare Professionals (HCPs) in a truthful and balanced manner. Ensure great experiences whenever stakeholders in the ecosystem engage with Roche employees, products and services.
+ Pull in expertise and resources locally and from the network as needed, prioritize and drive solutions that deliver outcomes faster. Boldly act on key decisions and opportunities and boldly stop any activity that is not adding value.
+ Identify important data gaps and opportunities designing and supporting data generation plans to address them including phase IV studies, registries and real world evidence generation.
+ Hold an altruistic approach in supporting the global network.
+ Act as a leader, coach and mentor, who supports team working and actively contributes to the learning & development of peers across strategically aligned therapy areas, key medical affairs capabilities and engagement with healthcare professionals and patient groups.
+ Display integrity in all levels (i.e. open, honest, ethical and genuine). All Roche employees are expected to practice high standards of compliance with both external and internal policies andregulations as well as participate and be involved in SHE initiatives within the Company.
+ Supports GxP-related activities to ensure quality compliance requirements are adhered to
**Who You Are:**
+ Is self-managed and self-directed, ready to take on empowerment. Demonstrates a growth mindset, able to learn and unlearn quickly, take risks and experiment.
+ Has an enabler mindset leveraging the internal and external networks to create value, sharing back and scaling. Has outstanding partnering capabilities such as coaching, consulting, ability tolisten deeply, question and understand.
+ Willing to travel when needed.
Skills and Experience :
+ Has a deep understanding of patient journey and related treatments, medical affairs strategies & tactics including clinical research as well as broad understanding of Roche's present portfolio andfuture pipeline, such that they can work on future-based solutions. Is able to effectively sharescientific information including investigational findings through direct communications andengagement at scientific conferences with healthcare professionals and/or the scientific community.
+ Has excellent stakeholder engagement skills including partnering with Therapeutic Area Experts (TAEs) and organizations isrequired. Experience partnering with Patient Advocacy Group(PAGs) is highly desired.
+ Evidence generation skills is required. Supports relevant Product Development Medical Affairs (Global Medical Affairs) (PDMA) and Country Clinical Operationstrial, Early Access Program and Compassionate Use program activities within their diseasearea/ecosystem
+ Work efficiently and harmoniously in a cross-functional team, able to formulate cross-functionalstrategies and orchestrate cross-functional teams. Experience in agile ways of working is highlydesired.
+ Experience with medical review of promotional materials is required.
+ Ability to leverage digital means and tools is required.
+ Proficiency in English is required, fluency in the local language is desired.
+ Trained in GMP and GDP requirements for pharmaceutical
Education & Expertise:
+ Medical degree and/or PHD preferred, bachelor's degree in life sciences (eg. immunology,biomedical, biology or pharmacy) required.
+ Minimum of 3 years experience within a Medical Affairs role in Pharmaceutical, Diagnostics,Health Sciences, Biotechnology or other related fields is required.
+ Experience and expertise in **Oncology** , specifically HCC and Lung Cancer is preferred.
**Who we are**
A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let's build a healthier future, together.
**Roche is an Equal Opportunity Employer.**

**It's more than a job**
When you work in Freight Logistics and Operations at Kuehne+Nagel, you play a key role in optimising processes and ensuring that inventory and shipments move efficiently. But that is not all. Your work also helps ensure that vital medicines reach patients on time and supports other essential deliveries, from wind turbines to semiconductors. At Kuehne+Nagel, our contribution counts in more ways than we imagine.
**‎**
The IL Quality Manager is an integral part of the Kuehne+Nagel Integrated Logistics (KN IL) Team and is responsible for providing expertise and necessary controls in the supply chain process in the area of quality and compliance throughout the supply chain. This position is also responsible for the implementation and oversight of a quality management system (ISO 9001 standard latest version) in line with relevant industry standards and regulatory requirements including WHO, EU GDP, FDA 21 CFR where applicable to meet both internal and external customer specific requirements.
The position will report according to KN IL organization chart, with close working relationships across the business including the Excellence Management, Operations Management, Performance Management and Business Analytics.
This is a key position within the customer dedicated set-up and represents a key interface with customers global quality and compliance team.
**How you create impact**
Problem Solving & Compliance Leadership
+ Ensure KN IL operations meet GxP, internal, and customer standards while managing escalations, CAPAs, and change processes to maintain operational integrity.
Quality Process Development
+ Develop, implement, and communicate quality standards; support regulatory approvals and certifications; align procedures with WHO GDP, EU GDP, and customer agreements; monitor compliance and performance.
Audits & Supplier Quality
+ Plan and conduct audits; manage supplier qualification; drive corrective actions and monitor effectiveness.
Training & Documentation
+ Implement GxP and quality training programs; maintain SOPs, technical agreements, and customer documents per ALCOA+ principles; ensure consistent documentation practices.
Non-Conformity & CAPA Management
+ Handle complaints, deviations, and CAPAs; perform root cause analysis; implement preventive measures; track trends to drive improvement.
Continuous Improvement & Stakeholder Engagement
+ Identify system gaps, implement improvements, enhance compliance and efficiency, and maintain strong relationships with customers and global quality teams; provide regular quality updates.
**What we would like you to bring**
+ Quality and/or regulatory experience in a pharmaceutical and/or distribution environment (minimum 5 years).
+ Six Sigma experience to be an advantage.
+ Knowledge of ISO 9001 & GDP standards (EU Guideline, WHO Technical series), common safety and health regulations.
+ Thorough GxP knowledge with proven track record.
+ Strong affinity with required customer quality standards.
+ Ability to communicate and negotiate on all levels, both internal and external .
+ Analytical way of working.
+ Flexible to travel.
**What's in it for you**
At Kuehne+Nagel, you'll be part of a global logistics leader that believes in creating real impact-on business, on customers, and on careers. Here's what you can look forward to:
+ Global Exposure: Step into a world of international opportunities with a presence in 100+ countries.
+ People-Centric Culture: Join a team where your voice matters and people genuinely care.
+ Learning & Development: Grow with us-personally and professionally-through world-class training and career pathways.
+ Innovation & Sustainability: Be part of a future-focused company driving real change in logistics and the planet.
+ Rewards & Recognition: Get rewarded for your passion, performance, and potential.
+ Stability with Agility: Enjoy the best of both worlds-a trusted global brand with a startup spirit.
**Who we are**
Logistics shapes everyday life - from the goods we consume to the healthcare we rely on. At Kuehne+Nagel, your work goes beyond logistics; it enables both ordinary and special moments in the lives of people around the world.
As a global leader with a strong heritage and a vision to move the world forward, we offer a safe, stable environment where your career can make a real difference. Whether we help deliver life-saving medicines, develop sustainable transportation solutions or support our local communities, your career will contribute to more than you can imagine.
Kuehne + Nagel is an equal employment/affirmative action employer. If you require an accommodation for any part of the online application process due to a disability, please contact the Employee Services HR Help Desk at during the hours of 8:00am - 5:00pm EST; Monday through Friday or via e-mail at: with the nature of your request. We will answer your inquiry within 24 hours.

**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role will work closely with client's Biomarker programming team and is fully remote based in India region.
**How you will contribute:**
+ Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
+ Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
+ Production and QC / validation programming
+ Support ad-hoc reports
+ Applying understanding/experience on PK/PD related analysis
+ Creating and reviewing submission documents
+ Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
+ Performing lead duties when called upon
+ Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
+ Being adaptable and flexible when priorities change
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
+ At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
+ Study lead experience, preferably juggling multiple projects simultaneously preferred.
+ Strong SAS data manipulation, analysis and reporting skills.
+ Solid experience implementing the latest CDISC SDTM / ADaM standards.
+ Strong QC / validation skills.
+ Good ad-hoc reporting skills.
+ **Experience of PK/PD analysis is a must.**
+ **Experience of oncology or immunology studies preferred.**
+ Strong knowledge in Macros/SQL and study specific macros and utilities.
+ Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
+ Submissions experience utilizing define.xml and other submission documents.
+ Experience supporting immunology, respiratory or oncology studies would be a plus.
+ Excellent analytical & troubleshooting skills.
+ Ability to provide quality output and deliverables, in adherence with challenging timelines.
+ Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Sponsor-dedicated:**
Working fully embedded within one of our pharmaceutical clients, with the support of Cytel right behind you, you'll be at the heart of our client's innovation. As a Senior Statistical Programmer you will be dedicated to one of our global pharmaceutical clients; a company that is driving the next generation of patient treatment, where individuals are empowered to work with autonomy and ownership. This is an exciting time to be a part of this new program.
**Position Overview:**
As a Senior Statistical Programmer, you will leverage your advanced SAS programming skills and proficiency in CDISC standards (SDTM & ADaM) to support or lead one or more Phase I-IV clinical trials. This role will work closely with client's Biomarker programming team and is fully remote based in India region.
**How you will contribute:**
+ Performing data manipulation, analysis and reporting of clinical trial data, both safety and efficacy (ISS/ISE), utilizing SAS programming
+ Generating and validating SDTM and ADaM datasets/analysis files, and tables, listings, and figures (TLFs)
+ Production and QC / validation programming
+ Support ad-hoc reports
+ Applying understanding/experience on PK/PD related analysis
+ Creating and reviewing submission documents
+ Communicating with and/or responding to internal cross-functional teams and client for project specifications, status, issues or inquiries
+ Performing lead duties when called upon
+ Serving as team player, with a willingness to go the extra distance to get results, meet deadlines, etc.
+ Being adaptable and flexible when priorities change
**Here at Cytel we want our employees to succeed and we enable this success through consistent training, development and support. To be successful in this position you will have:**
+ Bachelor's degree in one of the following fields Statistics, Computer Science, Mathematics, etc.
+ At least 8 years of SAS programming working with clinical trial data in the Pharmaceutical & Biotech industry with a bachelor's degree or equivalent. At least 6 years of related experience with a master's degree or above.
+ Study lead experience, preferably juggling multiple projects simultaneously preferred.
+ Strong SAS data manipulation, analysis and reporting skills.
+ Solid experience implementing the latest CDISC SDTM / ADaM standards.
+ Strong QC / validation skills.
+ Good ad-hoc reporting skills.
+ **Experience of PK/PD analysis is a must.**
+ **Experience of oncology or immunology studies preferred.**
+ Strong knowledge in Macros/SQL and study specific macros and utilities.
+ Familiarity with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials' data.
+ Submissions experience utilizing define.xml and other submission documents.
+ Experience supporting immunology, respiratory or oncology studies would be a plus.
+ Excellent analytical & troubleshooting skills.
+ Ability to provide quality output and deliverables, in adherence with challenging timelines.
+ Ability to work effectively and successfully in a globally dispersed team environment with cross-cultural partners.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.

**Job Description Summary**
Join GE HealthCare as a Lead Specialist in Regulatory Affairs and play a pivotal role in shaping the future of medical imaging. This global leadership position offers the opportunity to drive regulatory strategies and lead cross-functional teams to bring innovative X-ray imaging products to market. Be part of a dynamic environment where your expertise will directly impact patient care and healthcare outcomes worldwide.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Key Responsibilities**
+ Lead global regulatory projects to secure market authorization and promotional approval for medical devices.
+ Collaborate closely with product development teams, including engineering, marketing, clinical investigations, and regional regulatory experts.
+ Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines.
+ Identify and define product testing and clinical study requirements to support regulatory submissions.
+ Analyze and organize scientific data to demonstrate the safety and efficacy of medical devices.
+ Prepare and submit regulatory documentation to authorities across global markets including the US, Canada, Latin America, Europe, China, and Asia.
+ Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards.
+ Evaluate design changes and determine licensing or registration needs.
+ Review and approve promotional materials to ensure alignment with regulatory claims.
+ Monitor regulatory trends and communicate new requirements to internal teams.
+ Support regulatory inspections and audits as needed.
**Required Qualifications**
+ Advanced experience in Regulatory Affairs, ideally within the medical device industry, or advanced experience in product development within the medical device industry.
+ Bachelor's degree from an accredited university or college, or equivalent relevant experience.
+ Strong analytical, problem-solving, and project management skills.
+ Excellent oral and written communication abilities.
+ Proficiency in English (written and spoken).
**Preferred Qualifications**
+ Experience interacting with global regulatory agencies (e.g., FDA, Notified Bodies, NMPA).
+ Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks.
+ Proven ability to work independently in a fast-paced, dynamic environment.
+ Adaptability to change and capability to drive positive transformation.
+ Excellent team orientation and responsiveness to customer needs.
+ Detail-oriented with a focus on delivering results.
+ Experience working in multicultural and cross-functional teams.
**Inclusion and Diversity**
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
Our **total rewards** are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
#LI-RS1
#Hybrid
**Additional Information**
**Relocation Assistance Provided:** No

Let's do this. Let's change the world. In this vital role you will be responsible for manipulating large databases and generating reports to partner with epidemiologists to explore and generate RWE from real-world healthcare data assets. The ideal candidate should possess a bachelor's degree and have at least six years of relevant career experience in statistical programming. Proficiency in SQL programming and SAS or R programming is required. The successful candidate will demonstrate scientific and technical excellence, exceptional oral and written communication skills, problem-solving abilities, and meticulous attention to detail. The ability to work effectively within a large, globally distributed team is essential.
**Responsibilities:**
+ Provide technical solutions to programming problems within CfOR(Centre for Observational research).
+ Lead and develop technical programming and process improvement initiatives within CfOR
+ Represent the programming function and participate in multidisciplinary project team meetings
+ Project manage programming activities, according to agreed resource and timeline plans
+ Ensure programming activities adhere to departmental standards and SOPs
+ Write and/or review and approve programming plans
+ Write and/or review and approve analysis dataset specifications
+ Review and approve key study-related documents produced by other functions, e.g. SAPs, CRF, Data Management Plan, etc.
+ Write, test and validate software programs in Unix to produce analysis datasets and presentation output, to be included in reports for submission to regulatory agencies, publications and other communications
+ Write, test, validate and execute department-, product- and protocol-level macros and utilities
+ Oversee the work of outsourced resources assigned to projects
+ Lead and/or participate in the development and review of CfOR policies, SOPs and other controlled documents
+ Participate in study and systems audits by Clinical Quality Assurance (CQA) and external bodies, and respond to audit questions and findings
+ Participate in the recruitment of programming staff
+ Actively participate in external professional organizations, conferences and/or meetings
+ Provide input to and participate in intra-departmental and CfOR meetings
+ Contribute to the continuous improvement of programming, CfOR, and Research and Development (R&D)
+ Manage staff performance and oversee staff assignments and utilization
+ Relevant statistical programming, systems engineering or application programming experience in a clinical development or life sciences setting
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The (vital attribute) professional we seek is a (type of person) with these qualifications.
**Basic Qualifications:**
+ Doctorate degree OR
+ Master's degree and 4 to 6 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
+ Bachelor's degree and 6 to 8 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience OR
+ Diploma and 10 to 12 years of Computer Science, Statistics, Mathematics, Life Sciences, Economics or other relevant scientific subject experience
**Preferred Qualifications:**
+ Managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources in statistical programming projects
+ Training or experience using the Observational Medical Outcomes Partnership (OMOP) common data model.
Experience:
+ Real-world evidence (RWE) generation in pharmaceutical or related research industries, or statistical programming for clinical trials
+ Team management
+ Global collaboration
+ Request fulfillment oversight, clarifying requirements, project tracking, project fulfillment, statistical programming, issue resolution, expert resource, results delivery
+ Statistical programming: SQL required; SAS or R required; Python preferred
+ Experience working with real-world healthcare data (RWD) such as healthcare claims (MarketScan, Optum Clinformatics, Medicare) and EHR databases (Optum EHR PanTher, Flatiron, CPRD, MDV)
Key Competencies
+ Hands-on programming and lead role
+ Expert statistical programming knowledge using SAS or R
+ Required: SAS or R
+ Required: SQL
+ Preferred: Python
+ Excellent verbal and written communication skills in English
+ Ability to have efficient exchanges with colleagues across geographical locations
+ Agile project management
+ Real-world data (RWD) including insurance claims databases, electronic medical records and patient registries; for example, MarketScan, Optum, PharMetrics, Flatiron, Medicare
+ OMOP common data model
+ Drug development life cycle
+ Statistics and basic epidemiology: Incidence and prevalence
+ (Required for Regulatory RWE role): CDISC (SDTM, ADaM)
+ Scientific / technical excellence
+ Oral and written communication, documentation skills
+ Leadership
+ Innovation
+ Teamwork
+ Problem solving
+ Attention to detail
**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.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**

**What Will You Do:**
+ Assess regulatory intelligence for supporting development of local, regional, and global regulatory strategies.
+ Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
+ Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
+ Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
+ Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization and communicate with regulatory authorities throughout the product lifecycle.
+ Identify the need for new regulatory procedures, SOPs, and participate in development and implementation and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
+ Provide regulatory input and technical guidance on global regulatory requirements to product development teams and advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
+ Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategizes (if appropriate) for changes that do not require submissions.
+ Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
+ Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
**What Will You Need:**
**Basic Qualifications:**
+ BS in Engineering, Science, or related degree; and MS in Regulatory Science.
+ Typically, a minimum of 4 years of relevant experience.
+ MS or RAC(s) preferred.
**Preferred Qualifications:**
+ Good communication, good mentorship skills, stakeholder and time management skills, writing, coordination, and execution of regulatory items.
+ Demonstrates knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance and distribution.
+ Power platform skills and expertise in MS suite
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

**Key Accountabilities** :
The below responsibilities vary as per applicable as per the job role.
**General**
+ Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client's guidelines, and SOPs, and Global drug safety regulations
+ Maintaining an awareness of global regulatory reporting obligations and organizing work to ensure compliance with internal and regulatory timelines for the adverse event reporting
+ Assist in development of project specific safety procedures, workflows and templates.
+ Attend/Conduct internal, drug safety and project specific training sessions Completes trainings assigned on internal and client Learning Management System (LMS) as applicable
+ Preparation for, participation in, and follow up on audits and inspections Maintaining an awareness of the performance metrices measured by the client and striving to remain within established limits
+ Delegate work as appropriate to Drug Safety Assistants
+ Liaising and collaborating with the relevant function at the client's end to facilitate the delivery of high-quality work
+ Identifies areas of concern and raising the issues with senior management Assist with additional Drug Safety Specialist and/or senior management in project related activities as required
+ Mentoring new recruits in the team, if required
+ Archiving the source documents and relevant emails as required
+ Responds to clients/customers in a timely manner
**Case processing**
+ Monitoring of incoming reports from various sources viz mailboxes, Eudravigilance, literature searches etc.
+ Triage of incoming reports for completeness, legibility and validity, including literature abstracts/articles/citations
+ Preform a check on overall medical cohesiveness and consistency of the document
+ Compares and analyses data provided by the affiliate with the data available on client application
+ Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
+ Creates the case on the safety database and performs Data entry into safety database
+ Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
+ Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
+ Ensures MedDRA coding in accordance with "MedDRA Term selection: Points to Consider"
+ Request follow-up and perform query management, as applicable Prepares medically cohesive case narratives based upon the reported information
+ Routes the case to the next workflow state as applicable in the safety database Performs quality checks/validation checks
+ Perform literature searches as per search strategy, performs data entry of valid cases into the safety database
+ Case reconciliation- coordinating activities with Data Management personnel
+ Line listing and tabulation generation for safety reports i.e., periodic safety reports, ad hoc safety reports etc.
+ Supports compliance activities for ICSRs including late case investigation of ICSRs to various Health Authorities and Business Partners to determine the assignable cause for lateness and collection of lateness documentation including corrective actions, where applicable
+ Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
**Drug Safety Reporting**
+ Quality control of case reports, line listings, and tabulations Develop Expedited Reporting Procedures
+ Maintain local drug safety reporting requirements
+ Perform registration with relevant authorities for electronic reporting on behalf of sponsor
+ Perform setup and deployment of worldwide reporting as required to regulatory authorities, CECs, local ECs, and investigator sites (electronic and hard copy)
+ Submission of safety reports to investigators via SIS (Safety Information System)
+ Tracking and filing of submission cases as required Unblinding of SUSARs, as required
+ Collect and review metrics for measuring reporting compliance
+ Work with Global PV Information Office for collection and organization of global PV requirements
**Regulatory Affairs**
+ Compares the data received from client with the information present in database for the drug applications to be remediated; identifies and updates any missing information in the database
+ Creates new applications, regulatory events, product detail set, tasks, sequences and references in database based on instructions provided by client Responsible for maintaining and tracking changes in the life cycle of a medicinal product or device such as pharmaceutical strength, packaging, manufacturing sites, storage conditions or shelf life, etc. in the regulatory database per the information received from the client.
+ Creation of variations in the regulatory database to track labeling, quality or administrative changes, creation of references for responses to health authority regarding PSUSA or PBRER, Referrals etc. in the European Union region for National, Centralized, Mutual Recognition and Decentralized procedures.
+ Creation of reports for publishing in order to dispatch the dossier to affiliates or agency (EMA) and generation of marketing authorization status reports from the database for co-ordination of PV activities.
+ Validation the data content with the latest version of SmPC and performing the xEVMPD submissions via EMA Gateway for client's products and tracking the status of submissions and acknowledgement date.
**Literature Search and review**
+ Formulate and maintain the search strategy/strategies in line with parameters provided by the client to enable accurate and exhaustive identification and retrieval of scientific and medical literature articles from the literature database for ad hoc literature requests, regulatory requests and DSUR requests Send the citations retrieved to the requestor in the specified format Records are reviewed, and valid cases are entered into the client database Identification and maintenance of local journals in scope for local literature search
+ Performing Quality Check of the developed/updated search strategies and local journals.
+ Perform periodic review of database thesauri updates and implementation of necessary changes to the search strategies in a timely manner.
+ Interacting with internal or external contacts to resolve issues relatedto literature searches
**Skills:**
+ Sound knowledge of drug safety and the drug development process
+ Knowledge of and ability to interpret and apply global safety regulations
+ Experience in data analysis and evaluation of safety data
+ Good presentation skills
+ Analytical and problem-solving skills
+ Clear understanding of the regulatory submission process
+ Proficient in database/literature searches
+ Excellent interpersonal skills
+ Excellent verbal / written communication skills
+ Excellent organizational and prioritization skills
+ Ability to work collaboratively and effectively in a team environment
+ Client focused approach to work
+ Ability to evaluate data and draw conclusions independently
+ Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
+ Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point)
**Knowledge and Experience** :
+ Related experience in drug safety/ pharmacovigilance is desirable
+ Good knowledge of medical terminology
+ Excellent communication (written & spoken English + Japanese - JLPT N2 or above).
+ JLPT N2 or higher certification or equivalent
+ Experience with PMDA PV activities
+ Experience working with Japanese-speaking PV case processing teams
**Education:**
+ Degree in life Sciences, Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.), or relevant work experience in Pharmacovigilance.
+ A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage.
#LI-REMOTE
EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.