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8.0 - 12.0 years
0 Lacs
pune, maharashtra
On-site
As a Senior Regulatory Consultant specializing in Biologics/Biosimilars at Syneos Health, you will play a crucial role in authoring and reviewing CMC sections of regulatory submissions for various applications such as INDs, IMPDs, CTAs, BLAs, and MAAs. Your responsibilities will include developing and ensuring the completeness of CMC sections within IND and IMPD applications while adhering to regulatory guidance from FDA, EMA, and ICH. Your expertise in analytical method development, validation, comparability, biosimilarity assessments, upstream and downstream process development will be essential. Furthermore, you will provide peer review and mentorship to junior writers or team members to ensure consistency and scientific accuracy across deliverables. Experience with post-approval changes, tech transfers, and product lifecycle management will also be valuable in this role. In addition to primary skills, deep understanding of CMC regulatory requirements for biologics/biosimilars and experience with biosimilars, monoclonal antibodies, recombinant proteins, or other biologics are secondary skills required for this position. Ideally, you should possess a minimum of 8 years of experience in CMC-Biologics along with a Master's degree in pharmaceutical sciences or other life sciences. Your ability to work independently, manage multiple priorities in a fast-paced consulting environment, and attention to detail are crucial for success in this role. Experience with RIMS/Veeva Vault for submission management and regulatory compliance is preferred. At Syneos Health, we are dedicated to developing our employees through career progression, supportive line management, training programs, and a total rewards program. Our Total Self culture fosters an environment where authenticity is encouraged, and diversity of thoughts and perspectives are valued. Join us in our mission to accelerate the delivery of therapies and change lives. Learn more about Syneos Health and the impactful work we do across 110 countries with 29,000 employees.,
Posted 6 days ago
2.0 - 6.0 years
0 Lacs
chennai, tamil nadu
On-site
You will be responsible for developing and implementing systems for organizing, storing, and retrieving documents in a digital format. This includes creating and maintaining document management policies, procedures, and workflows. As part of your role, you will administer and maintain document management systems (DMS) and develop procedures for data entry and processing. Regular audits will be conducted to ensure compliance with policies and procedures, and you will also be involved in training employees on document management procedures and providing support to end-users. Your duties will include managing document versions, ensuring the correct version is in use, and tracking changes. You will be tasked with developing and maintaining document metadata and classification systems to facilitate information retrieval. Security of digital documents and information will be a key focus, including access control and data encryption. This position is available as both full-time and part-time, with benefits including Provident Fund. The work schedule is during the day shift, and the work location is in person.,
Posted 1 week ago
0.0 - 4.0 years
0 Lacs
noida, uttar pradesh
On-site
You will be part of our team as an Admin Assistant where you will play a crucial role in providing administrative support to our management team. Your organizational skills, motivation, and open-mindedness will be valued in this dynamic work environment. Your responsibilities will include offering high-level administrative assistance to executives and the management team. You will efficiently manage calendars, appointments, and meetings, ensuring smooth operations. Additionally, you will be responsible for preparing and organizing various documents and reports. Flexibility and willingness to travel when required are essential for this role. The ideal candidate should be well-presented, proficient in computer operations, and demonstrate a strong desire to grow and contribute to the success of the company. This position offers various job types such as Full-time, Part-time, Permanent, Fresher, and Contractual/Temporary. The work location for this role is in person, allowing you to actively engage with the team and contribute effectively to the company's success.,
Posted 2 weeks ago
0.0 - 4.0 years
0 Lacs
chennai, tamil nadu
On-site
As a Documentation Specialist, you will be responsible for creating, managing, and maintaining accurate and organized documentation, such as technical manuals, user guides, or internal processes. Your role will involve ensuring clarity, consistency, and compliance with industry standards. Your key responsibilities will include: - Writing, editing, and formatting various types of documents, including user manuals, technical guides, process documentation, and more. - Collaborating with subject matter experts (SMEs) to gather information and ensure the accuracy and completeness of documentation. - Maintaining a systematic and organized system for storing, retrieving, and updating documents. - Reviewing and editing documents to ensure clarity, consistency, and adherence to company standards. - Ensuring that documentation complies with relevant industry regulations and standards. - Effectively communicating with various teams and stakeholders to gather information, provide updates, and address documentation-related questions. - Identifying opportunities to improve documentation processes and workflows to enhance efficiency and quality. This is a full-time, permanent position suitable for freshers. The benefits include Provident Fund, performance bonus, and yearly bonus. The work schedule is during day shifts and morning shifts. The work location will be in person. Join us as a Documentation Specialist and contribute to maintaining high-quality documentation that supports our organizational goals and objectives.,
Posted 3 weeks ago
0.0 - 4.0 years
0 Lacs
karnataka
On-site
Join our team at Happy Living company as a "Female Office Coordinator Intern" and embark on a journey of learning and growth! As an intern, you will play a crucial role in supporting our office operations and ensuring a smooth and efficient workflow. Your English proficiency (spoken) will be a valuable asset in communicating with colleagues and clients. As the Female Office Coordinator Intern, your day-to-day responsibilities will include assisting in managing office supplies and inventory, coordinating meetings, appointments, and travel arrangements, handling incoming calls and emails, directing them to the appropriate person, assisting in preparing and organizing documents and reports, helping in maintaining office cleanliness and organization, supporting in planning and executing office events and activities, and collaborating with team members on various projects and tasks. If you are a proactive and detail-oriented individual looking to gain hands-on experience in office coordination, apply now and be part of our dynamic team at Happy Living company! About Company: HappyLiving, a sanctuary where wellness is a journey, not just a destination. As a pioneering wellness coaching entity, our essence lies in nurturing the mind, body, and spirit to cultivate a state of lasting well-being and joy. Diverging from traditional health coaching, we focus on holistic wellness strategies that empower you to overcome anxiety and embrace a life of fulfillment and balance.,
Posted 1 month ago
4.0 - 8.0 years
0 Lacs
haryana
On-site
As a TP Accounting Specialist, your primary role will be to ensure compliance with UAE Transfer Pricing regulations under Corporate Tax Law. You will be responsible for identifying related parties and connected persons, compiling transactional data, and reconciling intercompany ledgers to uphold accuracy and adherence to the arms length principle and documentation requirements as mandated by UAE Law. Your key responsibilities will include identifying Related Parties and Connected Persons as per UAE Corporate Tax Law, maintaining an updated list, determining the nature of transactions with each related party, reconciling ledgers with related parties to ensure balance accuracy, and compiling all related party transactions for a given financial year. You will also support the Tax team in preparing data for various disclosure forms and assist in preparing supporting documentation to justify the arms length nature of related party transactions. To qualify for this role, you should have a CA, MBA (finance) or equivalent qualification along with 4-6 years of experience in accounting, audit, or tax, preferably with exposure to intercompany or related party transactions. A working knowledge of accounting principles (IFRS/GAAP) and general ledger systems (e.g., SAP, Oracle, Tally, etc.) is essential. Proficiency in Excel, especially in VLOOKUP's, pivots, reconciliation formats, and document organization, is required. Preferred skills for this role include familiarity with UAE Transfer Pricing, experience in preparing reconciliations, schedules, and intercompany statements, a high attention to detail, accuracy, and data integrity, as well as strong organizational and communication skills.,
Posted 1 month ago
0.0 - 4.0 years
0 Lacs
chennai, tamil nadu
On-site
We are seeking an Administrative Coordinator to join our team and serve as a central point of contact for our employees and vendors. Your responsibilities will include assisting with the day-to-day office operations, screening phone calls, and coordinating internal meetings. The ideal candidate will possess exceptional organizational skills, the ability to prioritize tasks effectively, and a commitment to meeting deadlines. In this role, you will play a key part in providing administrative support to our team and ensuring the seamless execution of daily procedures. Your duties will involve managing and directing phone calls to the appropriate parties, tracking and reporting office expenses, maintaining both physical and digital employee records, scheduling internal and external meetings, handling incoming mail, as well as overseeing office supply inventory and procurement. Additionally, you will be responsible for making travel arrangements, organizing company documents within updated filing systems, addressing inquiries from employees and clients via various communication channels, preparing presentations and reports, and updating office policies as required. This position is a full-time opportunity suitable for both experienced professionals and freshers, offering a range of benefits including health insurance and Provident Fund. The work schedule may include day shifts as well as rotational shifts, with the potential for performance bonuses and yearly incentives. The role will be based at our physical work location. If you are a detail-oriented individual with a proactive approach to administrative tasks and a dedication to supporting organizational efficiency, we encourage you to apply for this role and contribute to our team's success.,
Posted 1 month ago
0.0 - 4.0 years
0 Lacs
chennai, tamil nadu
On-site
The role involves reviewing documents for accuracy and completeness, ensuring compliance with established standards and procedures. You will be responsible for converting paper documents into digital formats through scanning and indexing, assigning identifying information for easy retrieval. Accurate data entry and management in document management systems and databases is a key part of the job. You will be required to perform quality checks on processed documents to ensure accuracy and completeness. Maintaining organized files, both physical and digital, to ensure easy access and retrieval is essential. Collaboration with teams to identify areas for process improvement and providing support to colleagues is also expected. Operating and maintaining document processing equipment, such as scanners, copiers, and related machinery, is a part of the role. This is a full-time, permanent position suitable for fresher candidates. The work location is in person. For further details or to apply for the job, please contact the employer at +91 8610458898.,
Posted 1 month ago
1.0 - 5.0 years
0 Lacs
vadodara, gujarat
On-site
The role of Assistant at our company in Vadodara is a full-time, on-site position that involves managing daily office tasks, providing administrative support, organizing documents, scheduling appointments, and assisting with communication. As an Assistant, you will be responsible for handling correspondence, supporting team members, and ensuring that office operations run smoothly and efficiently. To excel in this role, you should possess strong administrative skills such as office management, schedule management, and document organization. Communication skills, including verbal and written communication, email correspondence, and interpersonal communication, are also essential. Proficiency in Microsoft Office, data entry, and basic IT troubleshooting is required. Additionally, organizational skills like time management, attention to detail, and multitasking abilities are crucial. Professionalism is key in this role, so we are looking for candidates who exhibit reliability, discretion, and problem-solving skills. The ability to work both independently and in a team setting is important. While prior experience in a similar role is a plus, it is not mandatory. A Bachelor's degree in Commerce, Business Administration, or a related field is preferred. If you meet these qualifications and are looking for an opportunity to contribute to a dynamic team, we encourage you to apply for the Assistant position at our company in Vadodara.,
Posted 1 month ago
2.0 - 5.0 years
2 - 4 Lacs
Bulandshahr, Khurja
Work from Office
Skilled in follow-ups, task tracking, MS Office & Google Sheets, scheduling, calendar management, and drafting emails. Strong in communication, relationship management, quick learning, problem-solving, and providing admin/report support
Posted 2 months ago
5.0 - 10.0 years
6 - 11 Lacs
pune
Work from Office
About Us: Levi & Korsinsky is committed to advocating for shareholders and consumers, seeking justice from major corporations and their executives. With decades of experience, our attorneys have established groundbreaking legal precedents in high-stakes securities and class action lawsuits nationwide. Our rapidly expanding marketing division, part of an established international law firm with over 22 years of history. We are rapidly expanding in-house team in technology, AI, CRM development, customer service automation, digital marketing. Job Overview: The Paralegal will play a crucial role in supporting both junior and senior litigation attorneys by providing essential organizational, document management, and administrative assistance. This position requires a keen eye for detail, a high level of responsibility, and the ability to work effectively under the supervision of experienced attorneys. Key Responsibilities: Document Organization & Management : Assist in the preparation, formatting, and proofreading of legal documents, filings, and correspondence. Ensure all documents are meticulously organized and stored, maintaining an efficient document management system. Litigation Support: Provide essential assistance to senior and junior lawyers throughout the litigation process. Tasks may include drafting and reviewing legal memoranda, preparing exhibits for hearings, managing discovery, and maintaining case files. Attention to Detail: Ensure the accuracy of all legal documentation, from formatting and citations to overall content. A keen attention to detail is critical, as you will be working with sensitive information in high-stakes cases. Collaboration & Training: Work alongside low-level and entry-level associates, assisting them with day-to-day tasks and ensuring that documents are prepared in compliance with firm standards. Senior lawyers will provide training and guidance as needed, offering mentorship and professional development opportunities. Senior Litigation Support: For more experienced candidates (25+ years of experience), this position will also involve supporting senior lawyers in complex litigation matters, requiring a high degree of trust, responsibility, and ownership over critical tasks. Qualifications: Experience : Minimum of 3+ years of paralegal experience in litigation, ideally within a law firm environment. For senior-level candidates (25+ years of experience), significant experience in complex litigation is required. Skills: Strong organizational, formatting, and document management skills are essential. Must have experience in proofreading legal documents for accuracy and detail. Professionalism : Ability to work independently with a high degree of responsibility. A strong sense of ownership and the ability to manage multiple tasks and deadlines is essential. Temperament : The ideal candidate should exhibit excellent communication skills, a strong work ethic, and a positive attitude in a fast-paced, team-oriented environment. Senior paralegals must demonstrate leadership and high trust value when managing important case files and tasks. Education: Paralegal certification or a related degree is preferred. Technical Skills: Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), legal research tools , and document management software. Experience with trial presentation tools is a plus. Work Location: We Work, Survey No. 25, Eleven West, Baner, Pune. Shift Timings: US Shift, 6:30 PM IST to 2:30 AM IST. Work Setting: Work from Office, 5 Days a week. Why you should Join Us: Competitive Compensation: We offer competitive salaries and benefits packages to attract and retain top talent. Work-Life Balance: We understand the importance of work-life balance and offer flexible work arrangements to help employees manage their personal and professional lives. Collaborative Environment: Levi & Korsinsky fosters a collaborative and inclusive work environment where employees are encouraged to share ideas and work together to achieve common goals. Opportunities for Impact: Working at Levi & Korsinsky means being part of a team that is dedicated to making a difference. Our work has a direct impact on the lives of shareholders and consumers.
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