580 Ich Jobs - Page 14

Veeva Vault RIMS L2 Support having 3-5 years of experience in RIMS. Veeva certification will be added advantage. The resource may have to work in CET timezone for initial few months. Client interview will be held post initial selection.

Manage and oversee legal receivables, ensuring timely recovery of outstanding amounts. Develop and implement effective strategies to minimize legal receivables and improve cash flow. Collaborate with cross-functional teams to resolve customer disputes and issues related to legal receivables. Analyze and report on legal receivables performance metrics, providing insights for improvement. Ensure compliance with regulatory requirements and internal policies related to legal receivables. Maintain accurate records and documentation of legal receivables transactions and interactions. Job Requirements Strong understanding of legal concepts and principles related to financial institutions. Experience working with legal receivables, preferably in the BFSI industry. Excellent communication and interpersonal skills, with the ability to work effectively with customers and stakeholders. Strong analytical and problem-solving skills, with attention to detail and accuracy. Ability to work in a fast-paced environment, meeting deadlines and targets. Familiarity with banking software and systems, including mortgage processing and management tools.

As a A Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4)/ Associate Vice President(M5) The key responsibilities would include the following Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

As a A Compliance Team Member - Treasury Department Compliance Location Mumbai Number of Positions 1 Reporting Relationships Reporting to Deputy Vice President(M6) Position Grade Senior Manager(M4)/ Associate Vice President(M5) The key responsibilities would include the following: Supporting the business/treasury function of the bank by giving advisory on all treasury related matters from Compliance Perspective. Supporting the team lead in reviewing Treasury related Products, Policies, Processes and notes. It involves providing compliance advisory and feedback giving feedbacks and advice to ensure the bank processes are comprehensive and compliant with regulatory guidelines. Advising on all matters relating to Market risk. Review and support the team lead in advising/reviewing all Statutory Audit Related Certificates. Advising on all matters relating to Finance including Disclosures in financial statements related to Investment, Borrowing, Derivative, Market risk, Liquidity risk etc. Collaborating with other assurance functions like risk and internal audit for regulatory matters. Carrying out select testing and monitoring of regulatory risk areas of treasury to ensure compliance with RBI guidelines. Getting involved in implementation of new circular at Bank level on all treasury related matters. Assisting the team during the time of RBI Audit by co-ordinating and collaborating with stakeholders to provide information and details requested by RBI. Resolving the points raised by RBI in inspection reports including conducting root cause analysis for regulatory violations. Engage with regulators and support business stakeholder needs as and when required, to obtain clarity on the regulations and secure approvals where required. Supporting the team lead in business reviews, review of concurrent audit reports, preparation of MIS data etc. CA/MBA Degree Knowledge about key regulatory requirements relating to banking and financial services segment. Hands-on experience of implementing or monitoring implementation of regulations/ Prior audit or assurance background will be preferred. Ability to perform under pressure within the given time lines. Should possess good communication / interpersonal / problem solving skills and has to be a quick learner. Diligent, hard-working & a team player, with ability to drive outcomes when working with other stakeholders. Proficient in working on MS Office tools

Business Unit PSL Product Team – Corporate, Institutional & Investment Banking PSL Product team takes care of entire priority sector lending portfolio for Corporate, Institutional & Investment Banking group. PSL product team is responsible for Identification, classification and reporting of Priority Sector book. The team is also responsible for working out structuring for various PSL deals in close co-ordination with Business units. Role PSL Product Manager Objective To drive Priority Sector Lending business, ensure accurate classification and reporting of PSL assets in Wholesale banking business Responsibilities PSL Reporting, PnL Management & Portfolio Management Ensure PSL reporting is completed timely and in adherence to extant regulatory guidelines and updation of Product notes or assigned products in line with change in regulations/RBI/SIDBI/Ministry of MSME etc. Managing the PSL portfolio of Wholesale banking and internal/external audits for this portfolio Drive projects for digitisation/ automation of PSL reporting Manage PnL for PSL portfolio of Wholesale banking Driving PSL Book Growth Drive PSL book growth for WBG organically & inorganically by way of Corporate linked PSL structure, securitization / on-lending etc. Generate vendor Financing and Agriculture PSL leads. Meet clients, structure PSL deal and conclude the same in close co-ordination with Relationship Team Prepare Program note incorporating PSL complaint structures and arrange approval from requisite sanctioning authority To execute client/ vendor (Farmer level) documentation in close co-ordination with on filed SeSo official and/or Business Correspondent Review PSL process note for process upgradation from time to time Due Diligence Conduct due diligence of PSL proposal post disbursement, by sample audits based on requirement. Drive PSL - to build mindshare towards PSL: Explore PSL opportunities in corporate banking Conduct trainings & reviews with Business team Experience CA/ MBA with 3-6 years of experience. Some experience in similar field is added advantage. Essential competencies - Flair to work in Priority Sector Lending Group - Good communication skills - Ownership, Result oriented , growth mind-set. Base Locations Kotak Mahindra Bank Mumbai

Role – Team member – Compliance Experience – 5 years Grade – M5/M6 Qualification – CA/MBA Keeping track of updates in regulatory guidelines applicable to company, assess the impact on processes/policies and ensure implementation of changes. Driving compliance culture in organization and ensuring compliance with existing RBI guidelines Advising Business/credit on compliance related matters. Providing clarification to various stakeholders on compliance queries Maintaining policies of organization and ensuring periodic review of same as per regulatory/internal guidelines Submission of periodic RBI returns and responding to ad-hoc RBI data requirements Liaise with group company on compliance related matters and submission of periodic/ad-hoc data to group company Performing compliance reviews for different departments and periodical test checking of Internal Controls of the company Monitoring the compliance system of company and ensuring compliance of respective stakeholders on timely basis in system One point of contact of RBI and managing Internal/Statutory audits and RBI Inspections.

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Business and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Project Role : Application Lead Project Role Description : Lead the effort to design, build and configure applications, acting as the primary point of contact. Must have skills : SAP HCM Payroll Good to have skills : NAMinimum 5 year(s) of experience is required Educational Qualification : 15 years full time education Summary :As an Application Lead, you will lead the effort to design, build, and configure applications, acting as the primary point of contact. Your typical day will involve collaborating with various teams to ensure that application development aligns with business objectives, overseeing project timelines, and facilitating communication among stakeholders to drive project success. You will also engage in problem-solving activities, providing guidance and support to your team while ensuring that best practices are followed throughout the development process. Roles & Responsibilities:- Expected to be an SME.- Collaborate and manage the team to perform.- Responsible for team decisions.- Engage with multiple teams and contribute on key decisions.- Provide solutions to problems for their immediate team and across multiple teams.- Facilitate training and development opportunities for team members to enhance their skills.- Monitor project progress and implement necessary adjustments to meet deadlines. Professional & Technical Skills: - Must To Have Skills: Proficiency in SAP HCM Payroll.- Strong understanding of payroll processing and compliance regulations.- Experience with SAP HCM modules and integration with other systems.- Ability to analyze and troubleshoot payroll-related issues effectively.- Familiarity with data management and reporting tools within SAP. Additional Information:- The candidate should have minimum 5 years of experience in SAP HCM Payroll.- This position is based at our Pune office.- A 15 years full time education is required. Qualification 15 years full time education

Skill required: KYC Screening - Know Your Customer (KYC) Designation: Regulatory Compliance Associate Qualifications: Any Graduation Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do :Experience working in Client On-boarding, Account Maintenance, Customer Identification Program (CIP) and Know Your Customer (KYC) processes.Conducting PEPs (Politically Exposed Persons) screening and adverse media checksProven analytical skills, problem solving ability, and a control mentality paired with meticulous attention to detail.Aptitude for building relationships and ability to communicate complex issues to a wide array of internal clients with differing levels of product experience.Self-motivated and proactive team player who takes ownership and accountability & has strong organizational skills as well as the ability to effectively manage competing priorities.Flexible and able to work well under pressure, manage high volumes, and collaborate with a global team while maintaining a positive attitude.Proficiency using the Microsoft Office Suite in particular Excel, PowerPoint and Microsoft Word.Looking for someone with KYC experience along with ECDD/OCDD knowledgeBusiness and regulatory requirements, governance, operating model, process and system controls to verify the identity, suitability, and risks involved with onboarding and/or maintaining a business / customer relationship. This includes driving customer identification, customer due diligence & enhanced due diligence. What are we looking for Know Your Customer (KYC) Operations:Educated to Degree LevelFamiliar with a wide range of external data sources and third-party systems to be covered as a part of the due diligence process.Relevant financial service experience, ideally within risk, compliance or financial crime.A good understanding of effective risk managementExperience of working with high-risk client groupsKnowledge of the regulatory environment is highly desirableStrong analytical ability and attention to detail and strong research skills and experience with the Internet and on-line research systemsDetail oriented, with the ability to work independently and multi-task effectivelyExcellent written and verbal communication skillsFlexible to work in rotation shifts, time management, and ability to prioritize and work effectively to tight deadlines Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

Skill required: Membership - Life Sciences Regulatory Operations Designation: Health Operations New Associate Qualifications: Any Graduation Years of Experience: 0 to 1 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do Embedding digital transformation in healthcare operations end-to-end, driving superior outcomes and value realization today, and enabling streamlined operations to serve the emerging health care market of tomorrowYou will be a part of the Healthcare Management team which is responsible for the administration of hospitals, outpatient clinics, hospices, and other healthcare facilities. This includes day to day operations, department activities, medical and health services, budgeting and rating, research and education, policies and procedures, quality assurance, patient services, and public relationsYou will be expected to coordinate the essential documentation and resources required for the filing of global applications. Understand, manage & process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc. What are we looking for Looking for the candidate with Good Communication and written skills, any degree expect B.tech/B.ELooking for the candidate with Good Communication and written skills, any degree expect B.tech/B.E Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Any Graduation

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Key Accountabilities: Contracting deliverables Exercise good judgment in balancing the risks to the client in making budget and contractual decisions against the impacts to client clinical trial timelines Follow client processes to develop, negotiate, track and execute global clinical study agreements with institutions and investigators participating in sponsored clinical trials Work with partners to develop and oversee the global site budget process Work with clinical trial sites and directly negotiate cost, business and contractual terms and conditions with investigators/institutions, making changes to contract templates within the Legal division approved parameters Lead study level site contracting activities, direct other ICL and act as primary study point of contract for site contracting issues and timelines on assigned studies Partner with Legal and other divisions to manage escalations in the site budgeting and contracting space Partner with Legal, Finance, pCRO and other divisions to identify and implement areas of improvement in the site contracting space Applies acquired job skills and procedures to complete substantive assignments, projects and tasks of moderate scope and complexity in applicable discipline Collaboratio n Lead and develop relationships with key investigational sites and Site Management Organizations across the contracting and budgeting interface Collaborates with invoicing specialists and/or invoice service provider to ensure alignment with Investigative Site contracting and compensation requirements Interacts with clinical site contracts & legal contacts, client and partner legal team, study management, site payments team, peer site contracting colleagues, CRO site contracting teams Contributes to design, development and implementation of major business initiatives or special projects. Applies technical skills and discipline knowledge to contribute to achievement of client business objectives Compliance with Parexel standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required Updates CV as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements Skills: Balance of general business, compliance, finance, legal, and drug development experience Precise communications and presentation skills Ability to plan, identify and mitigate risks to site contacting timelines Ability to lead by influence rather than positional power to accomplish critical deliverables Success in working in a highly matrix based organization Fluency in written and spoken English is required Knowledge and Experience: Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities Knowledge of the principles, concepts and theories in applicable business discipline Experience in drafting and negotiation of Clinical Trial Agreements with clinical trial sites in a global operation preferred Education : Bachelor’s Degree or equivalent and 5+ years of experience in clinical development operations or clinical trial outsourcing OR Juris Doctorate or equivalent and 2+ years of experience in clinical development operations or clinical trial outsourcing

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English - Advanced About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your primary interaction is within your own team and your direct supervisor In this role you will be given detailed instructions on all tasks The decisions that you make impact your own work and are closely supervised You will be an individual contributor as a part of a team with a predetermined, narrow scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Clinical Data Services - Clinical Reports Management Designation: Clinical Data Svs Specialist Qualifications: BE/BTech/MCA Years of Experience: 7 to 11 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do You will be aligned with our Life Sciences R&D vertical. Our services span across the entire life sciences enterprise, from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Employees under this span will be a part of one of the sub-offerings - Clinical, Pharmacovigilance & Regulatory, helping the worlds leading biopharma companies bring their vision to life enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.The Clinical Data Management team focuses on the collection, integration, and availability of data at appropriate quality and cost. The team is responsible for performing data management activities including discrepancy review, query generation, and resolution. The team is also responsible for creating CRF Completion Guidelines (CCG) and SAE reconciliation guidelines. They help identify and raise protocol deviations in the database, perform edit check validation by creating test cases, write test scripts, and carry out database validation (UAT) against the specified CRF/ECRF. The team also managing clinical data management projects.In this role, you will be expected to develop clinical trial reports using SAS/ J-review / Congnos / SQL / PLSQL as per the study requirement. What are we looking for SAS ClinicalOracle Procedural Language Extensions to SQL (PLSQL)Python (Programming Language)R ProgrammingClinical Database ProgrammingAdaptable and flexibleAbility to perform under pressureProblem-solving skillsAgility for quick learningAbility to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of moderately complex problems May create new solutions, leveraging and, where needed, adapting existing methods and procedures The person would require understanding of the strategic direction set by senior management as it relates to team goals Primary upward interaction is with direct supervisor May interact with peers and/or management levels at a client and/or within Accenture Guidance would be provided when determining methods and procedures on new assignments Decisions made by you will often impact the team in which they reside Individual would manage small teams and/or work efforts (if in an individual contributor role) at a client or within Accenture Please note that this role may require you to work in rotational shifts Qualification BE,BTech,MCA

Job Purpose Responsible for the design and oversight of safety pharmacology, exploration, and GLP-compliant toxicology studies. Manage multiple projects efficiently across various stages of discovery, preclinical, and clinical development. Contribute to the preparation and review of regulatory submissions and engage with regulatory authorities and cross-functional asset teams This position is located in Hyderabad, Telangana, India. Duties And Responsibilities : Preclinical Pharmacology Design, supervise, and interpret in vivo efficacy studies using a range of disease models. Provide scientific and technical oversight for preclinical pharmacology programs. Prepare study proposals, budgets, and timelines. Lead and mentor scientific staff supporting pharmacology operations. Analyze and compile data, ensuring GxP-compliant documentation and reporting. Contribute to the drafting and revision of regulatory documents including investigator brochures and study reports. Toxicology & Safety Assessment Lead toxicology strategy across discovery, preclinical, and clinical development phases, with an emphasis on human risk assessment and elucidation of toxicity mechanisms for novel therapeutic targets. Act as the primary liaison with CROs, overseeing study conduct and coordinating with technical, veterinary, and scientific personnel. Manage outsourced GLP and non-GLP studies to ensure adherence to protocols, regulatory requirements, safety standards, and SOPs. Integrate expertise in toxicology, pharmacology, ADME, and regulatory guidelines to design robust nonclinical safety assessment strategies. Identify and apply innovative approaches to streamline and accelerate nonclinical development timelines. Critically evaluate study protocols, data sets, and reports to ensure scientific validity and regulatory compliance. Regulatory and Cross-Functional Support Lead or support the preparation of regulatory submissions (e.g., IND, CTA, IB, NDA, BLA). Develop and implement program-specific toxicology plans in collaboration with cross-functional project teams to support compound progression. Represent toxicology and safety pharmacology functions on multidisciplinary project teams. Author and review toxicology reports and regulatory documents; contribute to regulatory submissions and interactions with global health authorities. Represent toxicology function on multidisciplinary teams supporting all stages of drug development. Contributes to the development of high-quality regulatory submissions for global clinical trials and marketing authorizations. Communicate findings and recommendations effectively to project teams and senior leadership. Qualifications and skills : Ph.D. in Toxicology, Pharmacology, or a related field. Strong knowledge of regulatory guidelines (ICH, FDA, EMA) and GxP standards. Minimum 5 years of relevant industry experience in preclinical drug development, or equivalent regulatory experience. Proven experience in designing, managing, and interpreting non-clinical safety and efficacy studies. Demonstrated ability to prepare and review nonclinical sections of regulatory documents like CTA, IND, IB, NDA, BLA, etc. Effective leadership, project management, and cross-functional collaboration skills. Willingness to travel as needed. Strong communications skills and a track record of accomplishment managing client relationships as well as regulatory agencies for USFDA and EMA. Working conditions: This position operates primarily in an office setting and may include 10% of travel. Mandatory onsite presence is required. Physical Requirements: This is a largely sedentary role.

Select how often (in days) to receive an alert: Select how often (in days) to receive an alert: Who we are The opportunity The manager is responsible for the supervision, preparation, and critical review of high quality regulatory submissions to the regulatory agencies within company timelines and in accordance with regulatory guidelines. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his/her supervisor. The manager will be the product manager for the assigned products and will manage life cycle management activities such as variations, renewals, responses to HA queries and prepare packages for submission to Health Authorities in the required markets. He/she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance s. The manager will oversee any/all regulatory or team databases and trackers and will accurately update them when changes are required. The product portfolio will cover mature innovative medicines. How you ll spend your day Plans Regulatory Submission Tracker of all Life Cycle Management activities Worldwide Markets for the assigned products. Prepare submission strategy as per regulatory requirements in the given markets and works with cross functional teams for final package creation. Manages all operational activities as needed in Teva regulatory systems. Serves as regulatory representative and works closely with Worldwide markets to ensure timely submission; Maintains collaborative partnerships with stakeholders. Scope of Life Cycle Management Activities include all variations, renewals, PSURs, DSURs, RMPs and responses to queries from Health Authorities (EU/US/APAC/Other Markets) Provides input to KPI metrics for submissions and approvals Other projects and duties as required/assigned. Your experience and qualifications Pharm D/MS in a scientific discipline or equivalent education and related experience Master s degree in RA/QA discipline, a plus. Prior experience in managing life cycle management regulatory activities a plus; Ability to work independently and in a global environment with strong communication skills Minimum 8 years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience required with experience in EU/US/Worldwide markets for Manager Role, 8+ years for Senior Manager position Demonstrates an understanding of ICH and Regulatory Guidelines for US, EU and APAC markets. Demonstrates the ability to evaluate regulatory documents and determine appropriate action. Demonstrates excellent verbal and written communication skills. Shares concepts, ideas, information, and suggestions with management, peers and others. Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts. Demonstrates excellent organization skills and the ability to multi-task; detail oriented. Possesses strong critical and logical thinking. Teva s Equal Employment Opportunity Commitment Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

We are looking forward to work with strong SAP professionals with hands on SAP ATTP along S4 HANA Implementation. Note: Considering 15 days or less as NP. Job Description: Consultant for SAP Advanced Track and Trace for Pharmaceuticals (ATTP) Key Responsibilities: Must have technical knowledge and skills required to implement and manage SAP ATTP solutions effectively, deep knowledge on track and trace compliance with USA regulations, serialization, and data management in the pharmaceutical supply chain. Deep knowledge on configuration of SAP Advanced Track and Trace for Pharmaceuticals (ATTP) for pharmaceutical serialization and traceability, ensuring compliance with USA regulations. Deep knowledge of pharmaceutical industry regulations, including serialization requirements, EPCIS formats. Implement serialization solutions effectively within a pharmaceutical organization's supply chain. Set up and manage serial number management processes in SAP ATTP for precise tracking. Skilled in configuring, implementing, and customizing SAP ATTP solutions to meet compliance needs. Capable of integrating SAP ATTP with other SAP modules and systems for seamless data flow. Effective troubleshooting and problem-solving skills for addressing implementation issues. Strong communication skills to convey complex technical concepts clearly. Project coordination experience in aligning training with SAP ATTP implementation projects.

Description. Regulatory Associate. Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Essential Functions. Assists with preparation of product development documents including gap analyses and clinical development plans.. Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.. Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.. Performs quality checks on related documents.. Assists with submissions of other regulatory documents and other regulatory research as needed.. Assists clients, customers, or others with general information. Gathers, compiles, analyzes, and reports information.. Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Summary. Under supervision, supports regulatory agency submissions, regulatory research, and product development. Responsibilities typically include the creation of submission documents to support investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorisation transfers (MATs) and other lifecycle maintenance activities.. Show more Show less

Description. Sr Medical Writer (CTT). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Mentors and leads less experienced medical writers on complex projects, as necessary.. Acts as lead for assigned writing projects.. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. -Develops or supports a variety of documents that include, but not limited to:. Clinical study protocols and clinical protocol amendments;. Clinical study reports;. Patient narratives;. Clinical development plans;. IND submissions and annual reports;. Integrated summary reports;. NDA and (e)CTD submissions;. Investigator brochures, as well as;. Clinical journal manuscripts, clinical journal abstracts, and client presentations.. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team providing review commentson draft and final documents.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.. Maintains awareness of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned. Minimal travel may be required (less than 25%). Trial transparency deliverables, protocol registration, protocol maintenance task, result posting for(CT.gov and EudraCT). Redaction of protocol and SAP (Statistical Analysis Plan). Qualifications. Minimum 7 years of experience in Medical Writing and atleast 5+ years of experience in Clinical Trial Transparency(CTT). Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Summary. Roles within the Medical Writing job family at the P22 level are responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports. This includes special summaries from raw data for submission to regulatory agencies or for in-company use, monographs, comprehensive reviews, scientific exhibits, and other projects requiring skill in medical communication. The role involves screening, analyzing, and summarizing additional data from other sources as needed, conducting systematic literature searches and reviews, preparing literature for new products, and revising existing medical communication. These roles review and analyze statistical outputs to prepare results-based documents such as clinical study reports and development safety update reports. They support engagement and interaction with regulatory agencies through the preparation of briefing books and response documents to health authority questions. They may be responsible for entire projects or processes within their area of responsibility. Impact and Contribution Roles within the Medical Writing job family at the P22 level play a crucial role in ensuring the clear and accurate completion of medical writing deliverables, presenting scientific information clearly and accurately. They manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision. These roles lead the resolution of comments from clients and complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings. They adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides. These roles coordinate quality and editorial reviews, ensure source documentation is managed appropriately, and act as peer reviewers for the internal team to ensure document scientific content, clarity, overall consistency, and proper format. Core Focus. Leading the clear and accurate completion of medical writing deliverables. Managing medical writing activities associated with individual studies. Coordinating these activities within and across departments. Completing a variety of documents, adhering to established regulatory standards. Coordinating quality and editorial reviews. Acting as peer reviewers for the internal team. Reviewing statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Interacting and building good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs. Performing online clinical literature searches and complying with copyright requirements. Identifying and proposing solutions to resolve issues, providing technical support, training, and consultation to department and other company staff. Mentoring and leading less experienced medical writers on complex projects. Developing deep expertise on key topics in the industry and regulatory requirements. Working within budget specifications for assigned projects. Show more Show less

Description. Sr Regulatory Associate (CMC). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Primary. Job Responsibilities. Practical understanding of ICH guidelines, GMP requirements, and regional regulatory frameworks (e.g., FDA, EMA). Post approval variation experience is mandatory for EU market and Preapproval MAA dosier experience for ROW is preferred.. Strong experience in preparation, compilation, review and submission of high-quality CMC dossiers for variations, renewals, annual reports, RTQs.. Can support change control assessment and impact assessments for global markets.. Capable to execute day-to-day tasks according to client processes and SOPs for building high quality global CMC dossiers.. Assists in training and mentoring of team members depending upon project requirements. Preparation, review and finalization of quality compliance reports, liaising with site, QA/ QP’s, CRAs and Client CMC team.. Ability to liaise with cross-functional teams (Quality, Manufacturing, Analytical, etc.) to gather necessary technical data and ensure regulatory consistency for global submissions.. Timely sensitization /escalation within team to maintain compliance and adherence to timelines.. Secondary. Understands Regulatory requirements for Marketing Authorization dossier applications for ROW markets.. Optional experience for tracking/ submission of regulatory/CMC commitments and update the databases. Hands on experience of RIMS/VEEVA vault.. Excellent written and verbal communication skills. Open to working in Cross-Cultural/Virtual teams. Attends client meetings as needed with relevant inputs. Good communication skills clearly articulate through emails/ calls; provide accurate update on regulatory activities for assigned products in internal or Client meetings. Qualifications. Minimum 4 years of experience required in preparation, compilation, review and submission of high-quality CMC dossiers for variations with Master’s degree in pharmaceutical sciences (preferred) or Master’s degree in other life sciences.. Ability to work independently and manage multiple priorities in a fast-paced consulting environment.. Detail-oriented, strong organizational skills to manage multiple priorities in a deadline-driven environment. Experience with RIMS/Veeva Vault for submission management, document lifecycle tracking, and regulatory compliance. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

Description. Medical Writer II (CTT). Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.. Discover what our 29,000 employees, across 110 countries already know:. WORK HERE MATTERS EVERYWHERE. Why Syneos Health. We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.. We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.. Job Responsibilities. Mentors less experienced medical writers on projects, as necessary.. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision.. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures.. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.. Serves as peer reviewer on internal review team. Addresses team comments accurately to ensure document scientific content, clarity, overall consistency, and proper format.. Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.. Performs on-line clinical literature searches, as applicable.. Working knowledge of drug development process and regulatory guidelines.. Continues professional development to keep pace with regulatory guidance and client expectations in medical writing that affect medical writing.. Stays aware of budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership.. Completes required administrated tasks within the specified timeframes.. Performs other work-related duties as assigned.. Minimal travel may be required (less than 25%).. Qualifications. Minimum 3 years of experience in Clinical Trial Disclosure (CTD), Clinical Trial Transparency (CTT) and Regulatory Medical Writing.. Preferred experience with results posting for regulatory bodies such as US FDA, ClinicalTrials.gov (ct.gov), EudraCT and national registries.. Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise.. Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.. Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.. Strong proficiency in Word, Excel, PowerPoint, email, and Internet.. Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information.. Get to know Syneos Health. Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.. http://www.syneoshealth.com. Additional Information. Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.. Show more Show less

We are a company dedicated to the audit and certification of national and international standards of quality and sustainability in products and processes.. We have an interdisciplinary team of professionals specialized in each industry and sector, committed to providing the highest quality service in a personalized way, generating long-term relationships with our clients and the community.. Our wide service offer, our extensive network of producers, processors and traders, our presence in fairs and seminars in different countries and our growing internationalization, make LETIS a link to the world.. Brief Job Description:. Audit preparation. Audit report preparation. Responding to technical queries.. Sending Audit Packs to Certifying office within stated timeline. Submission of Updated Audit Logs. Technical accuracy as per guidelines of audits packs. Client Satisfaction. Sociable with good market recognition and understanding. Technical Knowledge on the food sector audited. Presentable with the right mix of authority and convincing capability. Analytical capability and prompt decision making capability. Qualifications:. Essential:. Graduate/ Post Graduate in careers related to Agronomy Engineering or registered Rural Administration Technician, etc.;. To have knowledge and skills in organic production and handling techniques. At least 2 years of experience as an organic inspector in another Certifying Body (preferably in NOP regulations). Intermediate-advanced level of English (B2-C1). Desirable:. Food industry work experience with knowledge/ experience in auditing food safety management systems. with good Communication Skills , pleasing personality and proficient in computer usage. Please note it is mandatory to attach an audit log of audits conducted during your career, as well as professional references.. Show more Show less

Must have knowledge of documentation (COA, MSDS, VQ Filings , APQR, MOA,DMF) COA/ Certificate of Analysis • MSDS • Specifications/ TDS • Method of Analysis • Stability Data • DMF/ Drug Master File • Declarations Required Candidate profile Intrested Candidate Can share your CV in Whatsapp : 91-9724346949 / 9327657730

Job Description Responsible for overall engineering functions of OSD - plant Responsible for O&M of utility,HVAC, Water System and Process maintenance. Responsible for PM I Calibration I Facility maintenance and department safety functions. Responsible for regulatory I statutory audit compliance. Responsible for Preparation of maintenance reports budget and expenses control. Work Experience 20-25 years Education Graduation in Engineering or Electrical B.Tech in Engineering or Mechanical Engineering Competencies

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables function. Develop and implement strategies to improve collection efficiency and reduce delinquencies. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies. Train and guide junior staff members on receivables procedures and best practices. Job Requirements Strong knowledge of banking regulations and laws related to receivables. Excellent communication and interpersonal skills for effective customer interaction. Ability to work in a fast-paced environment and meet deadlines. Proficiency in MS Office and other relevant software applications. Strong analytical and problem-solving skills to resolve complex issues. Experience working in a similar role within the BFSI industry is preferred.