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3.0 - 7.0 years
5 - 9 Lacs
Pune
Work from Office
Job Description 1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets. 2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations. 3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures. 4) Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation. 5) Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries. 6) Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company. Work Experience 3 to 7 years Education Graduation Post Graduation in Pharmacy or Pharmaceutical Technology Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility
Posted 3 weeks ago
2.0 - 5.0 years
9 - 10 Lacs
Gurugram
Work from Office
Drafting, reviewing, negotiating and end to end management of company contracts with clients, vendors, NDAs etc Interpreting contracts and advising business team on contractual issues Automation of contracts Litigation Management Required Candidate profile Legal professionals with LLB and with a minimum of 2+ years in-house corporate legal departments only. Excellent comprehension, analytical and problem-solving skills
Posted 3 weeks ago
3.0 - 8.0 years
11 - 13 Lacs
Hyderabad
Work from Office
~Provide analytical support to Novartis internal customers (CPOs and Regional marketing and sales teams) on a variety of low-medium complexity analytical reports. ~Support and facilitate data-driven decision making for Novartis internal customers by providing and communicating qualitative and quantitative analytics . ~Support the GBS ~GCO business in application creation by being involved in various initiatives such as knowledge sharing, onboarding and training support, support team lead on all business related tasks/activities, process documentation and creation of knowledge repositories. ~Be an integral part of a comprehensive design team responsible for designing promotional marketing materials. Major Accountabilities ~ Build and deliver below client requirements against agreed SLAs. ~ Deliver services through a structured project management approach with appropriate documentation and communication throughout the delivery of services ~ Quality assurance; Ensure outputs are at the highest level for quality and accuracy. On-time project delivery within stipulated timeframes. ~ Support in establishing and maintaining standard operating procedures (SOPs) ~ Support in developing and maintaining knowledge repositories capturing qualitative and quantitative reports. ~ Participate in various knowledge sharing sessions Key Performance Indicators ~ Provide analytical support to Novartis internal customers (CPOs and Regional marketing and sales teams) on a variety of low to medium complexity analytical reports. ~ Support and facilitate data-driven decision making for Novartis internal customers by providing and communicating qualitative and quantitative analytics ~ Support GBS ~ GCO business in application creation by being involved in various initiatives such as knowledge sharing, onboarding and training support, support team lead on all business related tasks/activities, process documentation and creation of knowledge repositories. ~ An integral part of a comprehensive design team responsible for designing promotional marketing materials. Work Experience ~ Pharmaceutical industry experience ~ Project Management ~ Operations Management and Implementation Skills ~ Advertising Campaigns ~ Alteryx (Alternative) ~ Analytical Thinking ~ Brand Awareness ~ Business Networking ~ Curiosity ~ Digital Marketing ~ Email Marketing ~ Marketing Communications ~ Marketing Plans ~ Marketing Strategy ~ Media Campaigns ~ Process Documentation ~ Strategic Marketing
Posted 3 weeks ago
3.0 - 5.0 years
4 - 7 Lacs
Gurugram, Bengaluru, Mumbai (All Areas)
Work from Office
Role & responsibilities Performs range of legal & finance tasks under oversight of attorneys; specific responsibilities may include (but are not limited to): Allocate work assignments to counsels and keep track of progress in accordance with guidance provided by senior attorneys Draft and/or review NDAs, RFPs and waivers Support attorneys in responses to legal requests, track progress of matters, contract execution process, and filing of executed documents. Support attorneys in enforcing document retention policies and procedures Timely escalating for review by Contracting Coaches (Finance and Legal) and Senior management, against set parameters for the client contracting process Maintain databases for various initiatives/compliance processes Maintain all records and contracts and report, as needed, on active and closed matters Collaborate with team members on special projects Responsible for exception reporting by highlighting client studies/projects with delays in the contracting process. Be able to think and create various communication avenues for the legal team. Analyze data coming from volumes handled by the legal team and be able to make and lead presentations. Bi-monthly reporting/ updates to legal and finance Good skills on excel and PowerPoint.
Posted 3 weeks ago
6.0 - 11.0 years
22 - 27 Lacs
Hyderabad
Work from Office
The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions Documentation (SD) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements: PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement: Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology
Posted 3 weeks ago
3.0 - 5.0 years
5 - 9 Lacs
Hosur, Bengaluru
Work from Office
Roles Responsibilities : Execute legal agreements (NDAs, MSAs) with internal legal approval. Handle vendor registration with various platforms or customers. Manage internal accounts and documentation. Track regional sales opportunities ensure C4C system updates. Manage empanelment on PSU and government tender portals. Download and review relevant RFPs. Prepare pre-qualification (PQ) and technical qualification (TQ) checklists. Coordinate legal approvals for RFP clauses. Obtain internal approvals Prepare documents with required notarization and stamp paper. Liaise with internal teams to gather documents as per RFP checklist. Communicate with tender authorities regarding deadline extensions or clause clarifications. Consolidate submit final bid documentation according to portal submission requirements. Handle invoice submission at customer locations post-award.
Posted 3 weeks ago
9.0 - 13.0 years
35 - 40 Lacs
Vadodara
Work from Office
1. Characterization of RLD pack samples. 2. Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement. 3. Identification of new packaging material & new vendor development for packaging materials. 4. Mold development for primary packaging material & secondary packaging material & its validation. 5. Support to Regulatory team on ANDA s/NDA s filling for regulated market. 6. Coordination with NPI & planning team for launch of ANDA s/NDA s. 7. Preparation & revision of packaging material specification. 8. Preparation & review of MPC, FMEA, TA, DHF & AFMEA. 9. Preparation & review of Development Study protocol & report & execute the study. 10. Performing functional test as per regulatory requirement. 11. Coordination with Cross functional team like (FDD/RA/Plant/Marketing/PMO) for completion of task. 12. Participating in FAT of machines. 13. Support to plant for validation, trouble shooting and market complaints. 14. SOP preparation, periodic review and packaging lab equipment handling/maintain calibration records. 15. Preparation of Packaging documentation (Pack Style, Justification Report etc. as per Product/Regulatory) as required. 16. Handling of primary and secondary packaging material in storage area & maintaining the PM quantity for stability packaging at R&D.
Posted 3 weeks ago
5.0 - 7.0 years
7 - 11 Lacs
Pune
Work from Office
Energy feeds on energy. If you flourish in a fast paced, results-oriented environment, if you want to achieve individual success within a team first organization, and if you believe you can contribute and succeed in a demanding yet collegial atmosphere, then Lattice may well be just what you re looking for.Responsibilities & Skills What Will You Get to Do? Do you enjoy being an integral and valued member of a high-functioning legal team? Would you like to work for an innovative and dynamic multinational corporation? As a Commercial Transactions Counsel at Lattice Semiconductors, you will work on all aspects of commercial contracts at Lattice and work with the Sales, Marketing, Research & Development, and Global Operations functions to create, negotiate, and finalize various commercial agreements. This position will also oversee the company s NDA process, from beginning to end, including making any improvements to databases, working with the business to advise and execute NDAs, and becoming the in-house expert on NDA-related issues. This position requires exceptional time management skills, strong attention to detail, outstanding verbal and written communication skills, and the ability to nurture positive long-term relationships with internal clients, customers, and vendors. At Lattice one of our key values is collaboration. In this role, you will engage with energetic, driven, and kind professionals that work together to accomplish business objectives. You re Good At - The Ideal Candidate Has Extensive Experience with the Following: Drafting, reviewing, and negotiating relevant commercial agreements (including software licenses, sales, distribution, partnership, supply, subcontracting, agency, and confidentiality agreements ) in accordance with company policies, guidelines, internal policies and risk tolerance; Supporting contract negotiations in accordance with strategies defined with relevant functions and Legal; Collaborating with internal business clients and departments and coordinating the preparation of contractual risk assessments to obtain internal approvals before concluding contracts; Providing prompt legal advice and responding to a wide range of legal requests from internal clients across functional groups; Summarizing and communicating legal concepts that business clients can understand and apply; Identifying and addressing risks and issues in the daily business operations to ensure compliance with laws, regulations and internal processes and procedures; and Understanding the companys business model and applying that knowledge to minimize risk factors with customers and vendors. You Have: Bachelors Degree (LLB), Post Graduate Diploma, Professional Degree, Masters Degree in Law or equivalent is required At least 5 to 7 years of experience at a law firm and/or as in-house counsel supporting multinational corporations Prior experience in the development and implementation of negotiating information technology contracts for a multinational corporation preferred Strong presentation and communication skills - clear communicator with a good ability to communicate complex issues in a clear and simple manner in both writing and in person Excellent negotiating and drafting skills Exceptional time management skills and strong attention to detail; Excellent organizational, project management and interpersonal skills; ability to effectively work in teams, across functions, and with customers and vendors Possess technical excellence and a professional, commercial approach to problem solving Ability and desire to work collaboratively and autonomously Ability to navigate complex issues in developed and emerging markets Ability to perform in a fast-paced environment and handle multiple assignments and prioritize based on business need Strong teamwork mentality, with a willingness to pitch in and help when asked, even though it may not be in this role s core set of responsibilities Flexibility and agility to adjust a project or a deal as needed to deliver for clients and teammates should facts, circumstances, and timelines change Strong ownership of projects and matters from beginning to end Must be willing to attend meetings during morning or evening hours, as some clients may be located in other time zones. Who Are We? At Lattice, we are good at collaboration and problem solving. We re also good at having a bit of fun. We develop technologies that we monetize through differentiated programmable logic semiconductor products, system solutions, design services and licenses. We are the low power programmable leader. We solve customer problems across the network, from the Edge to the Cloud, in growing communications, computing, industrial, automotive and consumer markets. Our technology, long-standing relationships and commitment to world-class support enable our customers to create a smart, secure and connected world. Join Team Lattice and help us continue to drive innovation that creates a smarter, better-connected world. Together, we enable what s next. What are you waiting for? Apply today!
Posted 3 weeks ago
0.0 - 1.0 years
2 - 3 Lacs
Noida
Work from Office
Designation : Supervisor Posted Date : 21 May 2025 0 Yrs Not Disclosed Noida No.of Openings : 50 Notice Period : 1 Month Job description We have an opening of 50 Supervisor in Spot Billing Pvvnl Cluster project at Noida having 0 years experience . Qualification ITI,B.TECH (ELECTRICAL),B.TECH (COMPUTER SCIENCE),B.TECH (ELECTRONICS) Supervise and manage daily operations and staff. Ensure compliance with company policies and regulations. Monitor and report on performance metrics and KPIs. Collaborate with cross-functional teams on business initiatives. Provide training and support to team members. Maintain accurate records of operations and activities.
Posted 3 weeks ago
0.0 - 1.0 years
2 - 3 Lacs
Noida
Work from Office
Designation : Supervisor Posted Date : 21 May 2025 0 Yrs Not Disclosed Noida No.of Openings : 50 Notice Period : 1 Month Job description We have an opening of 50 Supervisor in Spot Billing Pvvnl Cluster project at Noida having 0 years experience . Qualification B.Com,B.TECH (MECHANICAL),DIPLOMA ELECTRONICS,B.TECH (ELECTRONICS) Supervise and manage daily operations and staff. Ensure compliance with company policies and regulations. Monitor and report on performance metrics and KPIs. Collaborate with cross-functional teams on business initiatives. Provide training and support to team members. Maintain accurate records of operations and activities.
Posted 3 weeks ago
2.0 - 4.0 years
4 - 6 Lacs
Bengaluru
Work from Office
About Scrumconnect Scrumconnect is a leading force in technology consultancy, contributing to over 20% of the UKs most significant citizen-facing public services. Our award-winning team has delivered more than 64 impactful services over the past two years, reaching over 50 million citizens and saving taxpayers over 25 million. At Scrumconnect, we foster a collaborative community of talented consultants who thrive on knowledge sharing, problem-solving, and continuous learning. Our mission is to combine cutting-edge software engineering, human-focused design, and data-driven insights to deliver exceptional service to our clients. Job Summary: Scrumconnect India is seeking a Legal Compliance Officer towork on UK jurisdictional matters. The successful candidate will ensurecompliance with UK legal standards, data protection laws, and other relevantregulations. Key responsibilities include conducting legal compliance checks,managing Tier 2 compliance, reviewing contracts, and handling data protectionfor UK-based operations. Key Responsibilities: 1. Legal Compliance Checks: - Conduct compliance checks aligned with UKlaws and regulations, ensuring the company adheres to necessary legalstandards. - Stay updated with changes in UK law andadvise the company accordingly. 2. Tier 2 Compliance: - Perform Tier 2 compliance checks and ensureadherence to UK government requirements. - Work closely with UK teams to ensure alloperations align with legal and compliance standards. 3. ISO and B Corp Documentation: - Manage and maintain ISO certificationdocumentation as per UK requirements. - Support the process for B Corpcertification, ensuring compliance with necessary standards and maintainingaccurate records. 4. NDA Management: - Draft, review, and manage Non-DisclosureAgreements (NDAs) between the company and external UK-based stakeholders. - Ensure that all NDAs meet UK legalrequirements and company policies. 5. Contract Review: - Review contracts between suppliers andbuyers, ensuring they are compliant with UK laws and protecting ScrumconnectUKs interests. - Work with UK legal teams to ensurecontracts meet required standards. 6. Data Protection Compliance: - Ensure compliance with UK data protectionlaws, including the General Data Protection Regulation (GDPR). - Implement policies for handling, storing,and sharing data in line with UK regulations. - Conduct Data Protection Impact Assessments(DPIAs) and advise on risks related to personal data processing. - Liaise with UK authorities on dataprotection and ensure that all privacy notices and policies comply with UKlaws. 7. Risk Management: - Identify legal risks specific to UKoperations and provide advice on mitigating potential issues. - Offer legal advice on regulatorycompliance, data protection, and contract matters. 8. Regulatory Updates: - Monitor changes in UK legal frameworks anddata protection regulations to ensure that Scrumconnect UK is fully compliant. - Advise senior management on necessary legalactions or updates based on UK regulations. Qualifications: - Bachelors degree in Law (LLB) orequivalent, with a focus on UK law. - Minimum 2-4 years of experience in legalcompliance, preferably working in IT or consulting services for the UK market. - Strong knowledge of UK ISO standards, BCorp requirements, contract law, and GDPR. - Experience with Tier 2 compliance is aplus. - Excellent organizational skills andattention to detail. - Strong communication skills to work withUK-based teams and stakeholders. Preferred Skills: - Knowledge of UK legal frameworks related todata protection and compliance. - Familiarity with UK corporate governance,risk management, and compliance processes. - Proven ability to handle multiple projectsand meet deadlines.
Posted 3 weeks ago
3 - 8 years
5 - 12 Lacs
Mysuru
Work from Office
Contract management Review NDAs in accordance with internal NDA playbook and manage NDA chart. Coordinate contract and legal department document management. Manage LEI chart and apply for initial LEIs and renewals via Bloomberg. Maintain and update Certificate of Incumbency for funds and corporate entities. Manage and populate contract abstraction chart. Assist with general corporate filings as needed (i.e. prepare FinCen BOIR reports). Manage fund and corporate entities via registered agent portal. Prepare state formation and dissolution entity filings.
Posted 1 month ago
6 - 8 years
6 - 12 Lacs
Chennai
Work from Office
Aspire Systems is currently on the look-out for candidates with expertise in Legal activities to join our Corporate Legal team. Work Location: Chennai (Siruseri - SIPCOT IT Park) Qualification: LLB/LLM or any equivalent degree related to Law Required Experience : 6 to 8 Years Key Responsibilities: Contract Review & Analysis : Review and analyze first-level contractual documents, including Master Service Agreements (MSA), Statements of Work (SOW), Non-Disclosure Agreements (NDA), and Change Orders (CO). Contract Drafting & Collaboration : Provide support in drafting and reviewing customer and vendor contracts, working closely with senior managers. Risk Analysis & Compliance : Assist in conducting risk analysis of contractual terms to ensure effective risk management and compliance. Contract Management & Delivery : Ensure adherence to contract management processes and ensure timely delivery of documents and deliverables. Internal & External Compliance : Work with the legal team to maintain compliance with both internal policies and external regulations. Cross-Functional Collaboration : Coordinate with cross-functional teams to resolve contract-related issues and support business goals. Adaptability & Multi-tasking : Adapt quickly to team dynamics and support tasks in a fast-paced, high-pressure environment, including collaboration across different time zones. Proficiency in Microsoft Tools : Utilize Microsoft Word, Excel, and PowerPoint for drafting, organizing, and presenting legal documents and reports effectively. Key Requirements: In-House Legal Experience : Previous experience in an in-house legal department or similar role is preferred. Contract Management & Compliance : Proficiency in managing contracts and ensuring compliance with relevant laws and regulations. Attention to Detail & Communication : Strong attention to detail, coupled with excellent written and verbal communication skills. Multitasking & Time Management : Ability to manage multiple tasks efficiently and meet deadlines in a fast-paced environment.
Posted 1 month ago
2 - 4 years
4 - 6 Lacs
Bengaluru
Work from Office
MORE ABOUT THIS JOB GLOBAL BANKING & MARKETS Our core value is building strong relationships with our institutional clients, which include corporations, financial service providers, and fund managers. We help them buy and sell financial products on exchanges around the world, raise funding, and manage risk. This is a dynamic, entrepreneurial team with a passion for the markets, with individuals who thrive in fast-paced, changing environments and are energized by a bustling trading floor. RESPONSIBILITIES AND QUALIFICATIONS The Transaction Management (TM) team is a business unit within the Global Banking and Markets division, primarily working with the Asset Financing, Structured Credit & Trading and Investment Banking groups across EMEA & APAC. The team is a multi-faceted diligence and origination team specializing in whole loan acquisition, sales, securitizations, syndication, and financing opportunities. The TM team has product expertise across mortgages, consumer loans, real estate/warehouse financing. TM Team is seeking an Analyst to lead TM functions. The Analyst will primarily be responsible for directing and facilitating internal and external workstreams with key business stakeholders ensuring completion of transaction closing requirements, and adherence to departmental, divisional and firmwide policies. Additional responsibilities include negotiating with, selecting and managing third-party vendor partners who perform due diligence, valuations, ratings etc. and provide various diligence related products and services; overseeing the vendor processes; and reporting results while identifying issues and the resulting impacts. Responsibilities Coordinate NDA negotiation process between internal and external legal counsels, leading to compliant sharing of information Collaborate with Sales, Trading, and Banking team(s) to run Conflicts check process, ensuring efficient completion to promote business development Perform transaction analysis to determine proper engagement of third-party vendors including but not limited to diligence, valuation, rating agencies, insurance advisors, etc. Calculate and reconcile invoices ensuring proper payment into and out of GS Track vendor and client engagement activities, ensuring efficient flows for follow on business and utilization of precedents across industry Maintain relationships with third party vendors to ensure competitive pricing and terms on behalf of financing clients, often acting as the first point of contact Perform primary liaison responsibilities between counterparties and internal groups for KYC and other client onboarding activities Ensure pre-execution workstreams are completed in a proper and timely manner, working with operations, servicing, compliance, controllers, and other internal teams Actively lead multiple ad-hoc ongoing projects aimed at supporting Resi, Consumer, and CRE priorities including but not limited to invoicing, client engagement, third-party engagement, data room management, risk management, etc. Contribute to process improvement initiatives and enhancements PROFILE: Familiarity with a rating agency/loan originator or servicer process, with a focus on capital markets and securitizations would be an added advantage Possess excellent time management/organizational skills with a keen eye toward attention to detail; must have ability to handle a high-stress, fast-paced environment, and aggressive deadlines with minimum supervision; successfully meet established project requirements and deadlines; must have ability to work independently and multi-task Strong ability to organize, analyze and interpret legal and compliance related materials Independent thinker who will be proactive, vocal and professional in dealings with internal/external clients, third-party vendor partners, internal teams, and senior managers; be able to work at the detail level while managing account relationships Outstanding initiative and excellent communication/presentation skills (both verbal and written) Advanced proficiencies in MS Office Tools. Capable of recommending modifications to existing policies/procedures to control risk and improve performance/efficiencies Must have ability to travel and work extended hours (and occasional weekends) as needed
Posted 1 month ago
6 - 11 years
6 - 12 Lacs
Ahmedabad
Work from Office
Role & responsibilities Core Responsibilities: Design and Analyze PK Studies Plan clinical PK studies synopsis and feasibility Analyze PK data using modeling and simulation tools (e.g., Phoenix WinNonlin, R software). Interpret PK parameters such as C_max, AUC, T_max, half-life, clearance, and volume of distribution. Support Drug Development Provide PK and statistical input in clinical development phase studies protocol Evaluate food effect, drug-drug interactions (DDIs), and bioavailability/bioequivalence studies and provide scientific inputs for study design & protocol preparation Support dose selection and optimization strategies for pivotal study design Regulatory Submissions Deep understanding and knowledge of regulatory guidance (like US FDA, MHRA, EMA, HEALTH CANADA, ANVISA etc) documents pertain to BABE as well as clinical trials Prepare and review PK-Statistical sections for regulatory documents (e.g., ANDA, IND, NDA, BLA, CTA). Respond to Health Authority questions related to pharmacokinetics. Cross-functional Collaboration Work closely with clinical, bioanalytical, statistical and regulatory teams. Participate in multidisciplinary project teams to inform decision-making. Data Interpretation & Reporting Summarize findings in study reports and scientific publications (as applicable). Present PK data to internal teams and external teams (Sponsor, DSMB and other regulatory bodies)
Posted 1 month ago
10 - 15 years
13 - 15 Lacs
Hyderabad
Work from Office
Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.
Posted 1 month ago
10 - 14 years
30 - 35 Lacs
Bengaluru
Work from Office
Skill required: Contract Management - Contract management Designation: Contracting Counsel Associate Manager Qualifications: Any Graduation Years of Experience: 10 to 14 years What would you do? Legal Buyside Contracting Role Summary To provide comprehensive legal support to Procurement and Business teams which includes drafting, reviewing, negotiation and execution of contracts, NDA's and other documents relevant to procurement support in accordance with company policies and procedures, applicable laws and customer requirements. Provide advisory support to procurement and business teams by driving the creation of templates, standardize the templates, maintain and continuously improve the standard contracts templates and procedures for complex buyside deals in accordance with changing laws and company policies. Develop specialized subject-matter expertise in support area to seamlessly address any potential risks or issues. Management Level DescriptionComplexity: Requires identifying and assessing complex problems for area of responsibility. Creates solutions in situations in which analysis requires an in-depth evaluation of variable factors. Requires adherence to strategic direction set by senior management when establishing near-term goals. Interaction is with senior management of the team, internal stakeholders third party vendors, contractors subcontractors etc., involving matters that may require acceptance of an alternate approach..Authority:Some latitude in decision-making. Acts independently to determine methods and procedures on new assignments.Impact or Decision Impact:Decisions have a major day to day impact on area of responsibility.Scope:Manages large - medium sized teams and/or work efforts (if in an individual contributor role).Generic Responsibilities Collaborate with other functional leads, sub leads to strategize and develop additional capabilities and create efficiencies within the team Manage the team and performance related aspects of the team (not applicable to individuals working as an independent contributor) Supervise the management of SharePoint and communication records, ensure creation of checklists and other process documentsRelationships:Supervises:?Team members providing services on a process/project or account/portfolio of accountsExternal Relationships:?Procurement, Business Executives, Contract Management, Outside counsels, Vendors, Corporate Function related stakeholders like HR, Workplace etc. What are we looking for? Qualifications:Education: Bachelor's degree in LawCertifications and Membership:?Contract related global professional certification considered a plusWork Experience:?Minimum of 5 to 15 years of experience at law firm or as in-house counsel and/or in legal outsourcingKnowledge and Skill Requirements: Expert level understanding of both commercial and legal contractual risks and displays ability to provide business-oriented legal advice Fluent in English with strong oral and written skills Experience in managing end-to-end projects and teams on function specific processes and/or areas, work with internal and external teams, and understands delivery requirements Demonstrate excellent interpersonal skills, is detail-oriented, has sound judgement, is adaptable, demonstrate promptness, accuracy, and consistency with the activities supported, and drive tasks to closure, has strong time management, prioritization, organizational skills Build trust-based relationships by delivering on commitments, ability to work under pressure, with exposure to senior management Effectively manage priorities and stakeholder expectations Able to effectively influence senior management. Behaviours and Attributes: Open to work with and understand cross-cultures and locations throughout Accenture global organization Understand the value of diversity and recognize the strengths that different styles, innovative perspectives and experiences bring to Accenture Demonstrate inclusion and respect for all individuals regardless of gender, race, ethnicity, religion, belief, age, disability, culture, social status and/or sexuality Leader as well as team player, collaborative and persuasive; able to work well with executives and non-executives. Roles and Responsibilities: Specific Responsibilities aligned to Role Draft, review and negotiate high value and high complex supplier/buyside agreements and similar/related documentation with Accenture suppliers, to procure various goods and services including but not limited to Contactors, Human Resources Support, IT & Telecom, Marketing & Communications, Workplace Support (Facilities & Services), Software as a Service etc. in accordance with Accenture's supplier's contracting standards, applicable laws, and business requirements. Address complex contract queries and matters regarding contract negotiations, obligations and revisions. Identify risks and issues, suggest alternatives that lead to the best solutions. In this regard effectively manage the internal stakeholders such as deal teams, Solution Architects, Procurement, HR, Workplace, Finance, Marketing & Communications etc., Strategize with company executives prior to vendor negotiations and represent the company's interests and liaise directly with vendor negotiating teams for legal point on complex contract reviews with high stakes for the company. Act as a point of contact from legal and work closely with the stakeholders to help them understand the contractual clauses in terms of interpretation and its applicability in the contract basis the business opportunity. Advise the Business from legal perspective to address the potential contractual risks that may pose as risks to Accenture business operations. Conduct gap analysis and create legal risk assessment by identifying and flagging potential risks to Accenture and/or clauses which are non-negotiable. Provide recommendations to Business and other related stakeholders to sensitize them on the extent of risk Accenture exposes itself in context of the services and to minimize or mitigate such risks effectively. Structure the legal transactions to be most advantageous from a contracting and business perspective and manage escalations Autonomously works across all categories and complexities of contractual agreements with vendor/clients deals including reviewing, advising and negotiating legal issues. Assign & Manage Tasks to the team. Manages escalations of serious or unresolved issues in accordance with prescribed guidelines and ensures all interested parties are kept informed and escalation controlled. Provide team members with positive and developmental feedback on their work product, conduct etc. as a supervisor or QA resource. Qualifications Any Graduation
Posted 1 month ago
3 - 8 years
12 - 14 Lacs
Hyderabad
Work from Office
Responsible for research and authoring of scientific response documents under the direction of the Global Medical Information (GMI) team in support of global and local medical information activities. Responsible for the execution of activities as required in alignment with GMI colleagues. Achieved through a combination of product knowledge, along with editing, writing, and document management proficiency. Essential Job duties and responsibilities: 1) Conducts literature searches and reviews, and extracts/summarizes complex data from the scientific literature. 2) Generates evidence-based, accurate, current, and fair-balanced summaries of data for the creation/maintenance of scientific response documents for products in designated therapeutic area(s). 3) Adapts global scientific response documents for assigned countries. 4) Develops responses to escalated inquiries for assigned countries. 5) Develops contributions to US NDA Annual Reports. 6) Contributes to US compendia reviews. 7) Contributes to peer reviews. 8) Demonstrates resolve and urgency to accomplish tasks without direct authority or control. Participate in cross-functional project teams as needed. Ensure that assigned projects are completed on schedule. 9) Develops and maintains Therapeutic Area expertise. 10) Reviews the content created by peer writers. 11) Collaborates effectively with Global Medical Information teams to execute content plans People: 1) Maintain effective relationships with the end stakeholders (Medical scientific community) within the allocated Global business unit and product - with an end objective to develop medical information content as per requirement. 2) Interact effectively with stakeholders in medical and pharmacovigilance departments. 3) Constantly assist other medical information writers in developing knowledge and sharing expertise. Performance: Provide deliverables (scientific response documents, US NDA Annual Reports, US compendia reviews) as per agreed timelines and quality Process: 1) Act as an expert in the field of medical information writing and maintain on the regulatory requirement for countries supported. 2) Assist the assigned medical information team in conducting a comprehensive medical writing needs analysis. 3) Implement relevant elements of content plans and associated activities for the year identified for the assigned countries. 4) Work with selected vendors within the region to deliver the required deliverables as per the defined process. 5) Design an overall plan of action basis end-customers feedback & improve course content and delivery. Stakeholders: 1) Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables. 2) Liaise with the Medical department to prepare relevant & customized deliverables.
Posted 1 month ago
4 - 9 years
6 - 10 Lacs
Bengaluru
Work from Office
Exceptional leadership capabilities, with a talent for motivating and engaging teams at every level of nbsp; the organization. nbsp; Proficient in articulating HR concepts and strategies to diverse audiences. nbsp; Proven track record in crafting HR strategies that not only align with but also drive business goals. nbsp; HR Expertise: Comprehensive knowledge of contemporary HR practices, regulations, and ethical standards within nbsp; the industry. nbsp; Talent Management Skills: nbsp; Extensive experience in modern recruitment techniques, talent development methodologies, and nbsp; high-impact performance management systems. nbsp; Strong analytical and critical-thinking skills to diagnose and resolve HR issues effectively and nbsp; innovatively. nbsp; Competent in analysing and interpreting HR data to derive insights that support organizational nbsp; effectiveness and inform strategic decisions. nbsp; Excellent interpersonal skills to build strong relationships with senior leadership and other nbsp; stakeholders, ensuring HR initiatives are effectively integrated with business objectives. White Gold is a technology-driven and innovative company that leverages advanced technology to nbsp; provide exceptional service to our customers. As a leading player in the gold buying sector, we are nbsp; dedicated to delivering unmatched value and satisfaction to our clients. With over 50 branches across nbsp; Karnataka and Kerala and a strong team of 200+ employees, we have built a reputation as a trusted name nbsp; in the market. Guided by our core values of integrity, innovation and customer satisfaction, we continue nbsp; to redefine industry standards and exceed expectations. nbsp; A HR Managers role is to ensure that all Corporate HR Operations are planned, develop and executed on an nbsp; ongoing basis within the organization. The manager will have to play a generalist role. nbsp; nbsp; Roles and responsibilities nbsp; Research and develop corporate policies and procedures for key aspects of HR in the organization to nurture a positive work environment and to optimize business. nbsp; nbsp; Implementing all HR initiatives, policies and systems in the organization. nbsp; Supervise, appraise and provide guidance to the HR personnel on HR related functions. nbsp; Plan and participate in weekly meetings with HR and Senior management for effective functioning nbsp; of all the areas and to address any issues that may arise. Update and maintain the recruitment tracker on an ongoing basis based on departmental needs. Source and shortlist relevant candidates and administer and assess pre recruitment test for those nbsp; shortlisted from first round of interview. Conduct first round of interviews and finalize selection of recruitment candidates for 2nd round of nbsp; interview with Senior Management Team. nbsp; Effectively carry out all the onboarding procedures for recruited candidates. nbsp; Assist in Implementation of disciplinary actions in case of violation of any of the policies and nbsp; procedures of the organization. Maintain original documents (Certificates, Agreements, NDA..) of all employees in safe custody. Set nbsp; and follow standardized procedures for issuing / collecting/ returning specific documents. nbsp; Prepare and issue the various HR documents ( Offer, appointment, agreement, NDA, KRAs, HR nbsp; letters, invites , appraisal formats, different employee letters.) to employees. nbsp; Fixing compensation package for various positions based on market trends, qualifications, nbsp; experience and their skills and abilities. nbsp; nbsp; Review, edit and collate data associated with the production of online employee handbooks linked nbsp; to Company policies, KRA and SOPs on coordination with Director HR Coordinate with Graphic Designer and Director HR to develop the design and final version of the handbooks and other related HR documents. nbsp;
Posted 1 month ago
5 - 7 years
5 - 7 Lacs
Noida
Work from Office
Key Responsibilities: •Litigation Management: •Handle and coordinate civil, commercial, consumer forums, RERA, NCLT/NCLAT, High Court and Supreme Court matters involving the company. •Draft legal pleadings, affidavits, rejoinders, and written submissions in coordination with external counsel. •Represent the company before courts, tribunals, and authorities wherever required. •Contract Drafting & Review: •Draft, review, and vet MOUs, lease deeds, development agreements, buyer agreements, NDAs, work orders, and other commercial contracts. •Provide legal support in documentation relating to project development, homebuyer communications, and compliance undertakings. •Regulatory Compliance & Governance: •Ensure compliance with applicable real estate laws, UP Apartment Act, RERA, Companies Act, and land acquisition laws. •Experience in working with RERA Authorities, YEIDA, and other government. departments •Advisory & Risk Management: •Advise internal teams on legal risks, mitigation strategies, and enforceability of obligations. •Participate in negotiations and settlement discussions with external stakeholders. •Corporate Legal Support: Key Requirements: •Educational Qualification: LL.B. (5-year or 3-year) from a reputed law school. •Experience: 57 years of post-qualification experience, preferably with a mix of law firm and in-house legal experience in infrastructure or real estate companies. •Skillset: •Strong drafting and research skills. •Knowledge of IBC, RERA, real estate laws, and contract law. •Ability to work independently and manage multiple legal matters concurrently. •Effective communication and negotiation skills.
Posted 1 month ago
1 - 4 years
1 - 4 Lacs
Hyderabad
Work from Office
Job Title: Business Development Manager Recruitment Services Location: I Floor, Serinity Square Vittal Rao nagar, Mindspace, Madhapur, Hyderabad, Telangana 500081 Department: Sales / Business Development Reporting To: Director / Operations Manager Experience Required: 2-4 years in Business Development (Staffing/Recruitment Industry preferred). Job Summary: We are seeking a dynamic and results-driven Business Development Manager to lead client acquisition efforts and expand our staffing business across IT and Non-IT domains. The ideal candidate will have a strong understanding of recruitment services, excellent communication skills, and a proven ability to bring new clients onboard and build long-term relationships. Key Responsibilities:Key Responsibilities: Acquire new clients for IT and Non-IT recruitment services (C2H & permanent staffing). Generate leads through cold calling, networking, and references. Drive the entire sales cycle from lead generation to closure. Build strong relationships with HR/Procurement decision-makers. Coordinate with internal recruiting teams to ensure high-quality delivery. Execute vendor onboarding documents – NDAs, MoUs, agreements. Achieve monthly and quarterly business targets. Handle client escalations and ensure smooth communication. NOTE: Candidate who got references are highly preferred. Preferred Skills & Experience: Proven track record in client acquisition or sales in recruitment/staffing. Strong knowledge of C2H, permanent, and volume hiring models. Familiarity with vendor onboarding processes and portals (e.g., Fieldglass, ProcureWise, EZAtlas). Exceptional negotiation and communication skills. Ability to work independently and handle escalations or client queries professionally. Bachelor's degree (MBA in Marketing/HR is a plus). Perks and Benefits: Competitive salary with attractive incentives Opportunities to work with top IT clients Growth-driven team culture Warm regards, Srinivas Rao Human Resource Business Partner Bose Software Services Pvt. Ltd. +91 99630 55516 srinivas.p@bosesoftware.com
Posted 1 month ago
8 - 10 years
15 - 16 Lacs
Mumbai
Work from Office
Job Summary Identify key therapy areas / products / complex generics / Sole FTF opportunity for US & OAM markets. Work on various themes to identify low competition ANDA opportunities. Make BC for identified products. Liason with RnD / RA / Clinical / API team / IP / Marketing etc . and compile relevant information. Get Cost of development / capex etc Present shortlisted products to Senior Management for addition to company pipeline, with objectives of achieving the business target and building potential for sustained revenue growth Identify and lead negotiations with CMO / CDMO for novel dosage form products Track Industry news / investor presentations / IMS / new approvals / FTF / Citizen petition opportunities etc and appraise relevant team members. Track novel NDA s of existing molecules (alternate dosage forms & new Strengths) Areas Of Responsibility Lead identification of key therapy areas / products / complex generics / FTF opportunity for US & OAM markets. Track products from the current US & EU pipeline for dosage extensions / alternate Dosage forms. Suggest products for In-Licensing where inhouse manufacturing is not feasible. Prepare and maintain business cases and prioritize projects based on inputs from R&D, manufacturing, network strategies, IP and commercial teams Qualifications : B Pharm / M Pharm + MBA Understanding of Pharmaceutical industry and regulations. Exposure to Drug development and business acumen Technology know how Compliance management Process excellence Execution focus Strategic Orientation People developer Accountability Collaboration Min 8 - 10 years of experience in the pharmaceutical / pharma consulting industry
Posted 1 month ago
6 - 11 years
5 - 8 Lacs
Ludhiana
Work from Office
Responsibilities: Spearheading the management of the company's internal contract management tools Drafting of contracts (MSA, NDA, Legal Contracts, Service Agreements) for the client Negotiating commercial contracts with the clients (B2B clients only) Vetting of the contracts shared and proposed by the client for the services to be provided Maintain a roster for renewal of contracts and ensuring that contracts are renewed and active timely and all times Coordinating with finance team to understand impact of the rates and thus partnering with BD team to get better rates for the services Handle the overall contract management for a set of clients based out of the office. Candidate must have: Graduation in LLB. Minimum 5 years of relevant experience in Corporate contract drafting, vetting and reviewing. Minimum 3 years of relevant experience in Negotiations of rates. Minimum 3 years of experience in client communication and client meetings. Excellent Contract Drafting, reviewing, vetting and Negotiation skills. Amicable Personality to lead Contract Management and handle independent conversations with Client companies across India. You are a detail-oriented person and follow a stringent timeline with regards to the delivery of your contracts.
Posted 1 month ago
3 - 5 years
5 - 7 Lacs
Pune
Work from Office
Job Title: Senior Sourcing Engineer - Indirect Sourcing Purpose: The Senior Sourcing Engineer will be responsible for managing and optimizing sourcing activities at GECIA for non-core/indirect procurement such as resource augmentation, software licenses, project services, training, and material procurement. The role emphasizes strong contractual negotiation, vendor management, purchasing compliance, and operational efficiency improvement. Key Responsibilities: Manage end-to-end sourcing operations for indirect categories including external resources, software licensing, project materials, and ad-hoc purchases. Evaluate, develop, and manage the vendor base, including commercial negotiations, contract finalization (NDA/SLA), and onboarding. Lead negotiations on pricing, contractual terms, and service agreements with vendors and suppliers. Drive cost-saving initiatives and identify efficiency improvements throughout the purchase-to-pay (P2P) cycle. Ensure compliance with legal, regulatory, and organizational procurement policies. Maintain vendor master data, track supplier performance, and conduct regular supplier audits and reviews. Create and maintain purchasing documentation, including contracts, audit reports, and operational records. Collaborate closely with internal stakeholders such as Competence Leaders, ACBS, Finance, and Business Users to align sourcing needs with business goals. Support license management processes, including procurement and renewals of software tools and systems. Monitor key performance indicators (KPIs) related to sourcing and drive continuous process improvements. Provide backup support to the indirect sourcing function when required. Required Skills & Experience: Bachelor s degree in engineering/technology (Mechanical / Production / Electrical). Minimum 4 to Maximum 8 years of experience in indirect sourcing, vendor management, and contract negotiations. Hands-on experience managing external resource vendors, software licensing procurement, service agreements, and project purchases. Strong understanding of purchase-to-pay (P2P) cycle management and operational risk control. Expertise in drafting, reviewing, and negotiating commercial contracts and agreements. Experience in cost optimization, process efficiency, and supplier performance improvement. Proficiency in Microsoft Office Suite, particularly MS Excel and MS Word. Excellent verbal and written communication skills in English. Strong planning, organizational, and stakeholder management skills. Preferred Skills (Good to Have): Exposure to License Management systems/tools. Experience in ERP procurement modules. Knowledge of sourcing in a global/multicultural environment. Personality Traits: Proactive and results-driven with a customer-centric approach. Strong interpersonal skills with the ability to collaborate across teams. Highly organized, methodical, and detail oriented. Ability to work independently and manage priorities effectively under pressure. Flexible and adaptable to dynamic business needs. Creative problem-solver with a focus on process improvements and operational excellence. Work Location: GECIA (Global Engineering Centre) - Hinjewadi, Pune, India. City Pune Last Day to Apply 28-05-2025
Posted 1 month ago
2 - 7 years
5 - 9 Lacs
Mysore
Work from Office
Hi, We are looking to expand our finance team in Mysuru/Mysore. Work from Office. Role & responsibilities Manage daily activities for Accounting Accounts Payables, and Accounts receivables Maintain all financial records and reports Follow-up with clients for Payments. Timely Monthly Closing and Financial Reporting to Manager. Processing of Vendor invoices after thoroughly checking of rates with contract & making timely payment of the same as per approval given. GST Return Processing of all routine expenses booking & payments as per approval. Processing & booking of Salary bank upload, tracking of all the payments done, wrong bank details to be reported & paid separately. Processing & booking of Statutory payments like PF. Processing & booking of TDS booking & payments. Checking the invoices before sending to final customers, if any deviations, reported to the Department. Raising of Invoices. Complete all the day to day accounting entries in Financials Software & support to other department staff in various routine accounting tasks. NDA and other agreement review Administration work. Educational Qualification: CA/CA inter/CA dropout/M.com Interested candidate please share your updated resume to nikita.singh@nemko.com or apply here on naukri.com.
Posted 2 months ago
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