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5.0 - 10.0 years
7 - 12 Lacs
hyderabad
Work from Office
Summary We are seeking for a highly skilled and motivated Forecasting Manager that is responsible for leading development of long- range, global forecasts that shape the future of Novartis portfolio. Located in Hyderabad and part of the Strategy & Growth (S&G) organization, you will report to the Forecasting Lead of Cardio- Renal- Metabolism (CRM) Therapy Area. You will get opportunity to closely collaborate with Therapeutic Area Strategy (TAS) Executive Directors and Directors, Commercial Marketing leads and other cross functional teams, for pipeline product assessments, supporting critical investment decisions (go/no go), whitespace analysis informing the strategy of the therapeutic area. You will be expected to contribute to innovation activities to enhance efficiency, robustness, and simplification of forecasting processes and deliverables. About the Role Key responsibilities: Foster strong stakeholder engagement to drive innovation and execute new projects across key areas, including but not limited to: Strategic forecasting for pipeline products Lifecycle management forecasting for inline and pipeline products BD&L opportunity assessments Critical business cases and investment decisions Ad- hoc forecasting support Collaborate with forecasting team members, strengthen functional capabilities, cross- functional stakeholders, and external vendors to deliver critical projects and build new capabilities. Establish and manage knowledge repositories capturing qualitative and quantitative insights on brands, and disease areas across Novartis operating markets. Deliver forecasting support through structured approach with appropriate documentation and communication throughout the delivery Actively participate in knowledge- sharing sessions to enhance expertise and improve the quality of S&G forecasting deliverables across the business unit. Leverage new data and technologies to enhance TA forecasting delivery and overall forecasting function Support the development and implementation of advanced data visualization and information presentation techniques. Work closely with other functions, including Competitive Intelligence, Primary Marketing Research, and Business Analytics, to leverage cross- functional synergies. Ensure full compliance with Novartis operational guidelines, including legal, IT, and HR requirements. Adhere to internal functional operating procedures, including time tracking, KPI monitoring, reporting, and compliance with internal systems and processes. Support the forecasting team in recruiting and onboarding new associates. ssential Requirements 5+ years in pharmaceutical/ healthcare forecasting, pipeline/ epidemiology forecasting. Strong ability to comprehend and synthesize data into actionable insights. Solid domain knowledge of the Global pharma market, including the US, JP, and EU regions. Proficiency in using pharma and clinical trial databases. Experience in conducting secondary data research or desk research on forecasting parameters. Expertise in epidemiology- based forecast modeling and long- range forecasting. Understanding of patient/forecast flow and Target Product Profile (TPP). Graduate / Postgraduate in Engineering / Pharmacy / Medicine / Science / Statistics / Business Desirable Requirements Exceptional business acumen and stakeholder management skills. Proven experience working in a matrix environment.
Posted 1 week ago
5.0 - 12.0 years
7 - 14 Lacs
bengaluru
Work from Office
IQVIA is looking for candidates who have expertise in regulatory writing to join our Real World Evidence team. The Ideal candidate will have 5- 12 years of experience working as Regulatory Medical Writer, adept in developing and authoring clinical study protocols, informed consent documents, clinical study reports. Expectations: Familiarity with the structural and content requirements of clinical study reports, clinical study protocols, and similar documents (not safety documents like PADERs, PBRERs etc. or clinical or non- clinical overviews at the moment); experience on real world studies will be an added advantage Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner Competence in completing a good first draft clinical study report or a clinical study protocol in a routine therapeutic area within are reasonable timeframe with limited guidance and/or supervision Good understanding of common statistical methods used in clinical studies and interpretation of their results Ability to give a simple presentation to a project team and/or customer, e. g. on Medical Writing processes Ability to identifying consistencies and deficiencies in statistical output/s Ability to work on several projects at once while balancing multiple and overlapping timelines Demonstrated abilities in collaboration with clients and internal stakeholders Knowledge of regulations relevant to regulatory framework/s Ability to work with cross functional team Experience in grooming /training junior writers and review their work Experience in leading small project team Education & Experience: Master s degree or PhD in the field of healthcare (e. g. Bio- medical sciences/ life sciences/ Pharmacy/ Bio- Tech, MBA in Pharmaceutical Management etc. ) Experience 8 to 12 Years . We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide .
Posted 1 week ago
5.0 - 12.0 years
7 - 14 Lacs
bengaluru
Work from Office
IQVIA is looking for candidates who have expertise in regulatory writing to join our Real World Evidence team. The Ideal candidate will have 5-12 years of experience working as Regulatory Medical Writer, adept in developing and authoring clinical study protocols, informed consent documents, clinical study reports. Expectations: Familiarity with the structural and content requirements of clinical study reports, clinical study protocols, and similar documents (not safety documents like PADERs, PBRERs etc. or clinical or non-clinical overviews at the moment); experience on real world studies will be an added advantage Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner Competence in completing a good first draft clinical study report or a clinical study protocol in a routine therapeutic area within are reasonable timeframe with limited guidance and/or supervision Good understanding of common statistical methods used in clinical studies and interpretation of their results Ability to give a simple presentation to a project team and/or customer, e. g. on Medical Writing processes Ability to identifying consistencies and deficiencies in statistical output/s Ability to work on several projects at once while balancing multiple and overlapping timelines Demonstrated abilities in collaboration with clients and internal stakeholders Knowledge of regulations relevant to regulatory framework/s Ability to work with cross functional team Experience in grooming /training junior writers and review their work Experience in leading small project team Education & Experience: Master s degree or PhD in the field of healthcare (e. g. Bio-medical sciences/ life sciences/ Pharmacy/ Bio-Tech, MBA in Pharmaceutical Management etc. ) Experience 8 to 12 Years
Posted 1 week ago
3.0 - 6.0 years
0 - 3 Lacs
hyderabad
Work from Office
Immediate Openings for-Business analyst Exp :3 to 6 years Skills:Pharma ,Life Sciences,QA, UI/UX,MS Word,Azure DevOps,Agile/Scrum,Waterfall. Location :Hyderabd Mode of interview : Virtual Mode of Employement:Permanent
Posted 1 week ago
3.0 - 6.0 years
3 - 4 Lacs
mohali
Work from Office
What You'll Do: Oversee daily store operations and ensure smooth functioning. Drive sales performance to meet revenue targets. Lead, train, and motivate the team for exceptional customer service. Manage inventory, stock replenishment, and merchandising. Ensure compliance with company policies and operational standards. What Were Looking For: Bachelors degree in any field. Prior experience in pharmacy store management preferred. Strong leadership, organizational, and communication skills. Ability to multitask and work efficiently under pressure. Proficiency in MS Excel and knowledge of the pharmaceutical industry. About Tata 1mg: Tata 1mg is a trusted health partner for end consumers and large institutions. Our Mission is to make healthcare understandable, accessible, and affordable for all Indians. Over the past three years, we've worked to build a healthcare platform that guides customers to the right and affordable care. Today, Tata 1mg is present in 1000+ cities And were just getting started. Leading the chart as one of the top consumer health platforms through ePharmacy, eDiagnostics, e-consult and offline stores, Tata 1mg has delivered over 15M ePharmacy orders, 2M eDiagnostics orders & 1M+ organic users/day in 2022 and we are just getting started. Our strongest asset is our 6400+ people enabling us to deliver on our mission consistently. Know more about us: https://www.1mg.com/aboutUs Contact us: 9810410943 Role: Retail Sales Associate IndustryType: Pharmaceutical & Life SciencesDepartment: Merchandising, Retail & eCommerce EmploymentType: Full Time, Permanent RoleCategory: Retail Store OperationsEducation UG: Bachelor Degree in any field.
Posted 1 week ago
3.0 - 6.0 years
3 - 4 Lacs
panchkula
Work from Office
What You'll Do: Oversee daily store operations and ensure smooth functioning. Drive sales performance to meet revenue targets. Lead, train, and motivate the team for exceptional customer service. Manage inventory, stock replenishment, and merchandising. Ensure compliance with company policies and operational standards. What Were Looking For: Bachelors degree in any field. Prior experience in pharmacy store management preferred. Strong leadership, organizational, and communication skills. Ability to multitask and work efficiently under pressure. Proficiency in MS Excel and knowledge of the pharmaceutical industry. About Tata 1mg: Tata 1mg is a trusted health partner for end consumers and large institutions. Our Mission is to make healthcare understandable, accessible, and affordable for all Indians. Over the past three years, we've worked to build a healthcare platform that guides customers to the right and affordable care. Today, Tata 1mg is present in 1000+ cities And were just getting started. Leading the chart as one of the top consumer health platforms through ePharmacy, eDiagnostics, e-consult and offline stores, Tata 1mg has delivered over 15M ePharmacy orders, 2M eDiagnostics orders & 1M+ organic users/day in 2022 and we are just getting started. Our strongest asset is our 6400+ people enabling us to deliver on our mission consistently. Know more about us: https://www.1mg.com/aboutUs Contact us: 9810410943 Role: Retail Sales Associate IndustryType: Pharmaceutical & Life SciencesDepartment: Merchandising, Retail & eCommerce EmploymentType: Full Time, Permanent RoleCategory: Retail Store OperationsEducation UG: Bachelor Degree in any field.
Posted 1 week ago
1.0 - 3.0 years
1 - 3 Lacs
mohali
Work from Office
Qualification-D Pharma, B Pharma, M Pharma What You'll Do: Manage day-to-day pharmacy operations, dispense medications, ensure accurate inventory and stock management, drive sales, and deliver excellent customer service while ensuring compliance with company policies and operational standards. About Tata 1mg: Tata 1mg is a trusted health partner for end consumers and large institutions. Our Mission is to make healthcare understandable, accessible, and affordable for all Indians. Over the past three years we've worked to build a healthcare platform that guides customers to the right and affordable care. Today, Tata 1mg is present in 1000 cities And were just getting started. Leading the chart as one of the top consumer health platforms through ePharmacy, Diagnostics, e-consult and offline stores. Tata 1mg has delivered over 15M ePharmacy orders, 2M Diagnostics orders & 1M+ organic users/day in 2022 and we are just getting started. Our strongest asset is our 6400+ people enabling us to deliver on our mission consistently. Know more about us: https://www.Img.com/aboutUs Interested candidates can Share their CV's at: 92895 67981 Role: Pharmacist / Senior pharmacist Industry Type: Healthcare Employment Type: Full Time, Permanent Role: Healthcare & Life Sciences-Other industry Type: Pharmaceutical & Life Sciences Department Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences-Other Education UG: B.Pharma in Pharmacy PG: M.Pharma in Pharmacy Role: Retail Operations Manager industry Type: Pharmaceutical & Life Sciences Department: Merchandising. Retail & eCommerce Employment Type: Full Time, Permanent Role Category: Retail Store Operations Education Doctorate: Ph.D/Doctorate in Medicine, Pharmacy
Posted 1 week ago
1.0 - 3.0 years
1 - 3 Lacs
panchkula
Work from Office
What You'll Do: Manage day-to-day pharmacy operations, dispense medications, ensure accurate inventory and stock management, drive sales, and deliver excellent customer service while ensuring compliance with company policies and operational standards. About Tata 1mg: Tata 1mg is a trusted health partner for end consumers and large institutions. Our Mission is to make healthcare understandable, accessible, and affordable for all Indians. Over the past three years we've worked to build a healthcare platform that guides customers to the right and affordable care. Today, Tata 1mg is present in 1000 cities And were just getting started. Leading the chart as one of the top consumer health platforms through ePharmacy, Diagnostics, e-consult and offline stores. Tata 1mg has delivered over 15M ePharmacy orders, 2M Diagnostics orders & 1M+ organic users/day in 2022 and we are just getting started. Our strongest asset is our 6400+ people enabling us to deliver on our mission consistently. Know more about us: https://www.Img.com/aboutUs Interested candidates can Share their CV's at: 92895 67981 Role: Pharmacist / Senior pharmacist Industry Type: Healthcare Employment Type: Full Time, Permanent Role: Healthcare & Life Sciences-Other industry Type: Pharmaceutical & Life Sciences Department Healthcare & Life Sciences Employment Type: Full Time, Permanent Role Category: Healthcare & Life Sciences-Other Education UG: B.Pharma in Pharmacy PG: M.Pharma in Pharmacy Role: Retail Operations Manager industry Type: Pharmaceutical & Life Sciences Department: Merchandising. Retail & eCommerce Employment Type: Full Time, Permanent Role Category: Retail Store Operations Education Doctorate: Ph.D/Doctorate in Medicine, Pharmacy
Posted 1 week ago
0.0 - 3.0 years
1 - 2 Lacs
becharaji, mandal
Work from Office
Job Title : Pharmacist Designation : Associate Pharmacist Location : Sitapur Note:- Gujarat State Council Registration is mandatory Roles and Responsibilities To Assist in Issue & Return of Material against Patient indents from Stores as dispatched by pharmacist. Issue & Return of Material against Departmental indents Receiving the material at Receiving Bay & Processing of Invoices Emergency Cash Purchase Receipt of consignment goods & Processing their Invoices on Consumption Physical Stock Verification Checking expires of medicine before dispensing to patients Ensure compliance to NABH and such other accreditations. Ready to do any other jobs assigned by superior/Incharge. Skills & Abilities Understanding written sentences and paragraphs in work related documents. Excellent Communication Skills (Written/Verbal) Problem Solving Skills Other requirements Can work on computer
Posted 1 week ago
0.0 - 5.0 years
3 - 4 Lacs
bangalore/bengaluru
Work from Office
We are hiring for Hospital Pharmacists @ Sakra World Hospital, Bangalore Requirements: Qualification: Diploma in Pharmacy/Bachelor of Pharmacy Experience: 0 to 5 years of experience KPC Registration Required Good Communication & Interpersonal skills Please mail your updated resume to raaz.chowdhary@sakraworldhospital.com Walk-in interviews Monday to Friday (10:00 AM to 2:30 PM)
Posted 1 week ago
0.0 - 1.0 years
1 - 3 Lacs
chennai
Work from Office
Immediate Hiring !! Designation: Medical Coding fresher Job Life science/Paramedical Fresher Salary: Upto 20k PM + Incentives. Shift : General, Day. Skills: Anatomy, Physiology, Pathology. Location: Chennai, Coimbatore, Bangalore. Required Candidate profile Eligibility: UG or PG or Diploma ( 3 Years) Specialization: Life Science, Non - Life science , Para-Medical & Medical Studies. Passout: 2020- 2024
Posted 1 week ago
2.0 - 7.0 years
2 - 5 Lacs
noida
Work from Office
The Clinical Pharmacist is responsible for ensuring the safe, and cost-efficient use of medications in patient care. Ensure compliance with hospital policies, federal regulations, and accreditation standards NABH.Improvement, and clinical audits.
Posted 1 week ago
1.0 - 5.0 years
6 - 42 Lacs
bengaluru
Work from Office
Responsibilities: Prescription Fulfilment Stock Management & Substitution Patient Counseling Delivery Coordination Customer Support & Inquiries Cash Handling Proper Storage & Security Inventory Verification Stock Entry
Posted 1 week ago
0.0 - 3.0 years
2 - 3 Lacs
hyderabad
Work from Office
Greetings From Scorelabs !! To follow the departmental SOPs strictly for all the responsibilities assigned. To dispense right medications based on the prescription received after checking the expiry, batch number and the MRP Required Candidate profile B Pharma / M Pharma with Pharmacy Council certificate holder Candidate with minimum 1 years of experience Freshers are also fine Should have PCI certification Hr Mounika - 8688334476
Posted 1 week ago
2.0 - 5.0 years
1 - 4 Lacs
bengaluru
Work from Office
The Pharmacist at Manipal Hospitals plays a crucial role in ensuring the safe and effective use of medications for patients. This position involves a variety of responsibilities, including but not limited to providing pharmaceutical care, managing medication therapy, and counseling patients on the correct usage of medications. The Pharmacist will collaborate with healthcare professionals to ensure optimal patient outcomes and participate in medication management programs. Roles and Responsibilities - Dispense medications accurately and promptly to patients, ensuring compliance with legal and professional standards. - Review and interpret physician orders to ensure appropriateness of therapy. - Provide medication counseling and education to patients and caregivers, addressing any concerns or questions. - Monitor patient outcomes and troubleshoot any medication-related problems. - Maintain accurate records of medications dispensed and controlled substances. - Participate in the development and implementation of clinical protocols and guidelines. - Collaborate with healthcare teams to optimize treatment plans based on patient-specific needs. - Stay up-to-date with current pharmacy practices, medication updates, and healthcare regulations. - Assist in inventory management, including ordering, stocking, and ensuring the quality of pharmaceutical supplies. Skills and Tools Required: - Bachelor's or Doctor of Pharmacy (Pharm.D.) degree from an accredited institution. - Valid pharmacist license in the respective state or country. - Strong knowledge of pharmacology, medication management, and pharmaceutical care principles. - Excellent communication skills, both verbal and written, for effective patient and team interactions. - Proficiency in using pharmacy management software and electronic health records (EHR). - Ability to work in a fast-paced environment and handle multiple tasks efficiently. - Strong analytical and problem-solving skills to assess medication therapies and patient needs. - Attention to detail and a high level of accuracy in dispensing medications. - Commitment to continuous professional development and knowledge of emerging pharmaceutical trends.
Posted 1 week ago
1.0 - 5.0 years
2 - 3 Lacs
thanjavur
Work from Office
Dispense medications accurately and efficiently. Counsel patients on proper medication usage, and storage. Maintain accurate records of medicines, stock levels, and expiry dates. Coordinate with doctors, nurses, and other for smooth operations.
Posted 1 week ago
0.0 - 5.0 years
1 - 3 Lacs
jaipur
Work from Office
Job Description :- Clinical Work Provide direct & indirect patient care in emergency care situations. Provide any & every detail about the procedures, medications, and answer patient queries & subsequent follow-up. Reporting & documenting USG findings/treatment plan in File/Portal. Documenting the prescribed mediation/Stimulation/HRT drugs etc. & in file/portal/ providing Trigger time. Executing all Donor Related Activity, in association with Donor Coordinator. Administer injection to patient/donor, as prescribed in file. Maintain stock of all required injections/drugs. Elicit accurate & relevant patient/donor medical history Co-ordinate procurement of necessary documents from patient/donor, per PCPNDT regulations. Update all patient records in both physical, as well as digital format. File all regulatory forms/consents before each procedure. Submit PCPNDT forms timely, as required by PCPNDT office. Identify & provide for physical, emotional, and developmental needs of patients. Counsel patients & their families; explain procedures planned for them. Ensure all procedures are carried out as per the SOP, and are compliant with the Policies on Universal Protection, Biomedical Hazard & Infection Control. Should have valid state registration Only immediate joiners apply for the role
Posted 1 week ago
3.0 years
2 - 2 Lacs
kochi, ernakulam
Work from Office
Qualification: - D pharm/B pharm Experience: - Minimum 3 years
Posted 1 week ago
2.0 - 7.0 years
3 - 8 Lacs
nagpur, pune
Work from Office
Were Hiring Across Multiple Functions | Join Our Expanding Team! Are you looking for a workplace where growth is fast , opportunities are limitless, and your work makes a real difference? We are on an exciting expansion journey and inviting talented professionals to join us. At our organization, you dont just build a career—you create impact, grow rapidly, and enjoy rewards that recognize your efforts. Current Openings: Nurse – Provide patient-centric care and be the backbone of clinical excellence. Financial Counsellor / Centre Manager – Patients Counselling & guiding patients with financial aspect. Drive smooth processes, manage centres, and ensure world-class service. Patient Relations Executive – Be the face of care, guiding patients with empathy and efficiency. Andrology Technician – Deliver specialized diagnostic and treatment support with precision. OT (Operation Theatre) Technician – Ensure safe and efficient clinical procedures in a state-of-the-art environment. Doctor Relations Executive – Build partnerships, drive growth, and shape the future of our brand. Why Join Us? Be part of an organization in expansion mode with fast career progression Medical Insurance for you & your family’s well-being
Posted 1 week ago
2.0 - 5.0 years
1 - 5 Lacs
nirmal, mumbai
Work from Office
Write and edit a variety of scientific and medical communication documents. Develop content and messaging for marketing materials related to healthcare and pharmaceuticals. Conduct thorough research to support ongoing projects and ensure accuracy of information. Interacting with designers. Ensure all written materials adhere to regulatory and compliance guidelines in the medical and pharmaceutical industries. Qualifications: Expertise in scientific and medical writing. Experience in medical communication. Strong research and writing skills. Degree in Life Sciences, Medicine, or Pharmacy. (B-pharm/ M-pharm
Posted 1 week ago
2.0 - 7.0 years
25 - 30 Lacs
hyderabad
Work from Office
Co-ordinate activities of data managers either internally or externally. Make data management decisions and propose strategies at project or disease level. May act as a local manager of global associates including providing supervision and advise to these data managers on functional expertise and processes Build and maintain effective working relationship with cross-functional teams incl. Trial Management, Trial Monitoring and Statistical Reporting counterparts, able to summarize and discuss status of deliverables and critical Data Management aspects impacting outcomes. Comply with company, department and industry standards (e.g. CDISC) and processes, ensuring data management innovations and foster data management solutions, ensure their efficient implementations and knowledge sharing within the project(s) or disease area. Maintain up-to-date advanced knowledge of industry software and reporting tools (e.g. Jreview/Spotfire) as well as industry requirements (e.g. CDISC SDTM/ADaM), attend functional meetings and trainings. Represent Data Management at audits and in Health Authority (HA) meetings for assigned project(s), or on data management aspects in external conferences or groups (e.g. SCDM). Provide authoritative technical and professional recommendations as representative of the data management function at project level or for a major non-clinical initiative. Provide thought leadership level support and guidance. Develops risk management strategies to prevent data quality issues from derailing projects. Carries out lessons learned in order to feedback and further enhance the DM processes Help with the recruitment of talent, coach and develop data managers. Leads/supports non-clinical special projects and initiatives like process simplification, automation, capability build. Provides subject matter expertise to special projects as needed Maintain external focus by interacting and influencing industry working groups and organizations
Posted 1 week ago
4.0 - 9.0 years
8 - 12 Lacs
hyderabad
Work from Office
Provide subject matter expertise to support digital endpoint deployment across clinical, scientific, and technology domains Provide digital health technology SME knowledge to support the qualification and onboarding of third-party digital health technology providers for clinical trials Manage vendor selection, oversight, and execution across all phases of trial start up, conduct and close out Drive operational integration of digital endpoints within Novartis processes and global clinical operations Monitor patient recruitment and device compliance, escalating risks and resolving issues as needed Support data management and data operations in database setup, data standards, transfer, cleaning, and analysis Lead process development and training initiatives to expand digital endpoint capabilities across teams Essential Requirements Advanced degree or PhD in Engineering, Life Sciences or Pharmacy with strong digital health and/or clinical development knowledge Minimum 4 years experience in clinical research, ideally with technologies, biomedical engineering, or bioinformatics Familiarity in developing and validating digital endpoints Familiarity of regulatory requirements across EMA, and USA regions Proven leadership, negotiation, and project management skills with ability to manage competing priorities Excellent interpersonal and communication skills across scientific and business contexts Strategic thinker with proactive problem-solving skills in trial design and delivery Knowledge of ICH/GCP and clinical trial technology landscape
Posted 1 week ago
5.0 - 8.0 years
5 - 9 Lacs
mumbai
Work from Office
Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents according to EU regulatory requirements. To identify and classify the changes as per EU regulatory variation guidance. To prepare response to regulatory deficiencies letters according to EU regulatory requirements To collaborate with other departments/partners To maintain lists/documents/records Responsible for keeping Orion internal regulatory system up to date and accurate To achieve his/her responsibilities within the agreed timescales To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating Other possible tasks appointed by Supervisors What we offer An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group Possibility to utilize your own strengths with the support of the professionals Flexible, high-spirit working environment where your skills are appreciated Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times). Good work-life balance Clear, transparent processes and responsible supervisors are our benefits to the personnel
Posted 1 week ago
1.0 - 4.0 years
15 - 19 Lacs
bengaluru
Work from Office
Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements. Partner with the CMC RA Scientist to plan and prepare submission content to support clinical studies and manufacturing process changes for development and marketed products. Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions. Responsible for triage of Lilly affiliate inquiries and requests and when necessary, consults with CMC RA Scientist for guidance in effort to prepare responses to questions. Implement and in some cases interpret global regulations and guidance s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Regional Submission Associate, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements. Partner with Regional Submission Associate to align on submission strategies and timeline for deliverables and manage communications between Regional Submission Associate, GRA-CMC scientists, RD&E specialists and Quality/Regulatory representatives.
Posted 1 week ago
8.0 - 13.0 years
30 - 35 Lacs
bengaluru
Work from Office
Lead a pioneering team at Amazon Pharmacy as we build our next-generation Pharmacy Warehouse Management System (WMS) from the ground up in Bangalore. As the founding development manager, youll establish and scale a high-performing engineering team focused on mission-critical fulfillment technology that ensures medication safety for millions of customers across America. Youll drive the technical vision and execution of complex distributed systems handling inventory management, order orchestration, and compliance-critical workflows, while integrating with cutting-edge robotics and AI/ML capabilities. This role requires a strong technical leader who can balance rapid innovation with unwavering quality standards in a highly regulated healthcare environment. Amazon Pharmacy is transforming healthcare delivery by combining Amazons customer obsession and operational excellence with pharmacy services. Youll partner closely with senior leadership to shape the technical strategy of this rapidly growing business, while building and mentoring a team of talented engineers. Your organization will be instrumental in scaling Amazons pharmacy operations nationwide, working with teams across the globe to deliver solutions that could fundamentally change how Americans access their medications. The ideal candidate brings experience leading complex technical programs, expertise in building highly available services at scale, and a track record of growing and developing engineering talent. If youre passionate about solving challenging technical problems while building and inspiring teams that deliver results, we want to talk to you. Building, leading and growing diverse, inclusive and high-performing engineering product teams, including recruiting, mentoring, motivating, promoting and performance management. Collaborate effectively with cross-functional teams including customers, product managers, stakeholders and leaders to ensure the successful delivery of product capabilities. Timely execution and prioritization of goals for the team and effectively mitigating risks. Strategic leadership to create product roadmaps, set the vision for the team and collaboratively partner with other stakeholder teams. Technical leadership including architecture and design discussions for science and engineering problems and technical deep dives to ensure resolution of root causes of complex issues. About the team Amazon s mission is to make it dramatically easier for customers to access the healthcare products and services they need to get and stay healthy.. Towards this mission, Amazon Pharmacy Fulfillment Tech strives to build technology to fulfill the world s healthcare needs as fast as possible at the highest quality, lowest cost, and greatest convenience. While our near-term focus is building fulfillment technology to support Amazon Pharmacy, our North Star Vision is to support the fulfillment of any type of healthcare experience at Amazon. To that end, our systems are flexible enough to integrate with other in-house and third-party systems and extensible to accommodate the ever-growing and changing healthcare needs of our customers. Whether it is building our own software or integrating with other in-house and/or third-party services, we strive to leverage the best-in-class technology available to deliver delightful healthcare experiences to Amazon customers, starting with Pharmacy. 8+ years of engineering experience 3+ years of engineering team management experience 8+ years of leading the definition and development of multi tier web services experience Knowledge of engineering practices and patterns for the full software/hardware/networks development life cycle, including coding standards, code reviews, source control management, build processes, testing, certification, and livesite operations Experience partnering with product or program management teams Excellent communication and articulation skills. Experience in communicating with users, other technical teams, and senior leadership to collect requirements, describe software product features, technical designs, and product strategy Experience in recruiting, hiring, mentoring/coaching and managing teams of Software Engineers to improve their skills, and make them more effective, product software engineers Familiarity with GenAI tools and their application in software development
Posted 1 week ago
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