Job Purpose: To lead, plan, execute, and deliver projects on time, within scope, and within budget by coordinating internal teams and external stakeholders. The Project Manager ensures that project objectives align with organizational goals, manages resources effectively, and mitigates risks to drive successful outcomes and client satisfaction. Key Expectation from the Role (In Brief): Understand the project requirements, the resources that are needed and align internally with other teams do that the project team is set up for execution of the project Capture the clients' expectations and establish a communication channel with the client on ongoing basis Build shared understanding with the client and freeze the scope of the project Establish the timelines for the project, do the resource mobilization viz. Domain team, SME, IT, etc. Manage the project delivery as per the laid down processes (SOPs) Identify and note any risks associated with the project right at the beginning, conduct frequent reviews and constantly strive for mitigating the risks Prepare the project plan, identify stakeholders for the project, manage the expectations and timelines Maintain the workplan and timesheet on a weekly basis Proactively anticipate issues, mitigate them and avoid escalation Manage critical resources within the project and try to have a backup so that project is not hampered

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)

Roles and Responsibilities Conduct bioanalytical research activities such as method development, validation, and sample analysis using techniques like HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. Develop and validate methods for bioanalysis of biologics and biosimilars according to regulatory requirements (e.g., USFDA). Collaborate with cross-functional teams to ensure timely delivery of high-quality results. Perform stability testing of biological products under various conditions. Troubleshoot issues related to instrument calibration, maintenance, and operation. Desired Candidate Profile Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Pharmacy (M.Pharma) from an accredited institution or M.Sc. Strong understanding of analytical instruments such as HPLC/UPLC/GC/MS/ICP-MS/Wet Analysis etc.

Role & responsibilities Assist in sourcing candidates through job portals, LinkedIn, and internal databases. Schedule interviews and coordinate with candidates and interview panels. Help in drafting and sending offer letters and appointment letters. Maintain recruitment trackers and update job postings on various platforms. Assist in updating HR policies and uploading them to the company intranet. Help in preparing and maintaining HR MIS reports and departmental organograms. Support in policy communication and compliance tracking. Contribute to planning and executing employee engagement activities. Assist in collecting feedback and preparing reports on engagement effectiveness. Provide administrative support to the HR team in daily operation. Participate in HR/OD projects and initiatives as assigned. Preferred candidate profile Pursuing or recently completed a degree in Human Resources, Business Administration, or related field. Good communication and interpersonal skills. Proficient in MS Office (Excel, Word, PowerPoint). Eagerness to learn and contribute to a dynamic HR team.

Job Purpose: The QA Auditor is responsible for evaluating and ensuring compliance with applicable regulatory standards, including Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP), across clinical research and laboratory operations. This role supports the organization's commitment to quality and regulatory integrity by conducting internal and external audits, identifying non-compliance, and driving corrective and preventive actions. The QA Auditor plays a critical role in maintaining high standards of data integrity, patient safety, and regulatory compliance, while supporting continuous quality improvement in alignment with international guidelines and sponsor expectations. Role & responsibilities: 1. Planning, Execution, and Oversight QA review of protocols, study/validation plan, and amendments, if any. Audit Planning and Management To plan & conduct in-process audit of studies and method validation to assure compliance with WHO-GCLP & applicable principles of GLP and ICH-GCP, SOPs, protocol, study plan/validation plan, STP, and applicable regulatory guidelines. Conduct retrospective audit of study raw data & report and validation raw data & report to assure compliance with WHO-GCLP and applicable principles of GLP & ICH-GCP, SOPs, protocol, study/validation plan & applicable regulatory guidelines, and prepare QA statement/authentication. To conduct system audit of various departments as per pre-defined schedule to assure compliance as per in-house SOPs and prepare & communicate audit report. Vendor audits/supplier audits. To review the Analytical and functional characterization data 2. Oversight of QMS Review of SOPs Monitoring and review of deviations Monitoring and review of change controls Monitoring corrective and preventive action 3. Assist in Sponsor Audits/Client & Regulatory Inspections To assist Lead, QA/designee to host sponsor/client audits and regulatory inspections. To assist Lead, QA/designee to address sponsor/client audit response as well as its closure (as applicable). To assist Lead, QA/designee to review regulatory audit response and queries as well as its closure (as applicable). To assist Lead, QA/designee to track, prepare and submit regulatory applications and follow-up until its approval. 4. Review & Monitoring To prepare and review quality assurance SOPs and review applicable operational SOPs. To review and provide inputs on audit reports prepared by QA team for delegated audits. To ensure closure of all raised observations and provide QA authentication. To ensure the controlling and distribution and QA data archiving. To ensure the controlling and distribution of documents. To update quality manual & its annexure periodically To assist Lead, QA/designee for trend analysis and quality review meetings. 5. Training & Development To train the new joiner in QA department on various QA aspects as well study/validation aspects as applicable. Maintain quality culture within department. 6. Other Responsibilities Any other responsibilities assigned by head, quality assurance/designee

Role & responsibilities Project Planning To collect primary details and timely prepare the feasibility & final proposal along with budgetary requirements in consultation with HoD. To prepare various templates for Project Management including elements like Monitoring Plan, Defining Team Members, Communication Plan, Escalation Plan, IP Handling Plan, Safety Management Plan, Risk Mitigation plan, Study Data Flow, Perform risk-assessment and execution plan for various client studies. Query resolution from clients and management, prepare a plan involving multiple stakeholders and its finalization. Plan and identify resource requirements, Project Monitoring & Co-ordination To perform a single point of contact between clients and internal stakeholders. To conduct periodic visits to various study sites, follow-up and coordinate for timely preparation of study documents (like protocol/ICF, CRF, Patient Diaries, etc.), disseminating milestones based on proposal and ensure timely achievement of the same. To co-ordinate for all start-up activities like vendor qualification, regulatory/EC submission and approvals, logistic, insurances, site identification and clinical trial agreements with them and creating all Study related plans, IP Management, ensure proper resource availability for the study and review various other study related requirements as per check-list. Project Review To undertake routine communication with the site Principle Investigators, attend periodic progress review meets with clients as well as sites and with internal stakeholders. To review all expenses and billing, /invoicing to sponsors, review the draft report and ensure timely submission of final report to sponsors. Audit & Compliance Be representative for all internal and external audits for COD studies, review and ensure timely responses to internal (QA/QC) and external (Sponsor/Regulatory) auditors. To prepare and keep updated the departmental SOPs and ensure compliance of the same. MIS To ensure update of all study specific progress MIS with milestones and commercials Team development & Team management Responsible for team development by mentoring and training. Responsible for approval of individual employees performance goals. Ensure the safety and well-being of departmental employees and provide assistance to resolve employee grievances. Responsible to approve leaves and attendance of team members. Reward and Appreciate employees to boost their morale Keep a check on departmental attrition and make efforts in reducing the same. Responsible to manage departmental work in absence of reporting manager. Any other task assigned by reporting authority.

Role & responsibilities Proficiency in organizing and communicating clinical information Excellent attention to detail, consistency, clarity and scientific rigor Continuous improvement and growth mindset Ability to work in a fast-paced and changing environment Accountable, focused, precise attitude Customer-service mentality and can-do attitude Exceptional command of written and spoken English at a professional level with the ability to write clear, concise and grammatically flawless medical/scientific content. Job Responsibilities 1. Works closely with cross-functional project teams to independently author scientifically accurate, comprehensive and compliant documents, including but not limited to clinical study reports, clinical study protocols, manuscripts, informed consent forms, patients narratives, abstracts, posters, oral presentations, etc 2. Manages the collection, consolidation and integration of comments/feedback from internal and external reviewers to efficiently finalize assigned writing projects 3. Performs thorough quality control checks, including copyediting, proofreading, and cross-verification of data within clinical documents and against source TFLs to ensure accuracy, consistency, and compliance with regulatory standards. 4. Ensure that the assigned deliverables strictly adhere to regulatory guidelines (e.g., ICH-GCP, EMA/FDA requirements), publication guidelines (ICMJE, GPP, journal/congress-specific requirements), client specifications, and Veeda's quality standards for content, format, and structure. 5. Streamline the review process by identifying and mitigating potential conflicts early, enabling the timely completion of high-quality deliverables. 6. Provide supervision and technical advice to other medical writers in the team and new writers joining the team, as required. 7. Apply broad therapeutic knowledge to adapt writing style and content for different disease areas and target audiences 8. Conduct literature reviews on assigned therapeutic areas and provide scientific support across departments throughout the clinical study lifecycle, ensuring adherence to timelines and project requirements. 9. Quickly assimilate new therapeutic area information to support emerging project needs 10. Maintain awareness of evolving guidelines and standards across relevant therapeutic fields 11. Provide support to Medical Writing department activities as needed

#hiring . Know anyone who might be interested? "Ahmedabad Location" Veeda Lifesciences is seeking a passionate "Business Development - Feasibility Lead". Experience Required: 0 to 3 Years Drop your CV to: mahendra.t3705@veedalifesciences.com Role & responsibilities Subject Matter Leadership Serve as the subject matter expert for feasibility-related practices and provide strategic input during protocol development and country/site selection. Stay current with global trends in clinical trial feasibility and apply best practices to enhance performance. Guide cross-functional teams on feasibility data interpretation, ensuring alignment with business and regulatory expectations. Project Delivery Lead feasibility components of assigned projects, ensuring timely and accurate completion in line with client requirements and internal SLAs. Manage multiple feasibility requests simultaneously, prioritizing effectively and ensuring resource optimization. Anticipate feasibility challenges and proactively develop mitigation plans. Reporting Provide regular and ad-hoc reports to stakeholders, including BD, operations, and leadership, on feasibility progress, timelines, and outcomes. Maintain up-to-date dashboards and trackers for transparency and informed decision-making. Support internal audits and client requests for feasibility-related documentation and metrics. Quality Assurance Ensure all feasibility work is conducted in compliance with ICH-GCP, applicable regulations, and company SOPs. Participate in internal quality audits and implement corrective actions as required. Promote a culture of quality and continuous improvement within the feasibility function. Policies, Processes & Procedures Contribute to the creation and revision of SOPs and work instructions related to feasibility and early engagement activities. Identify process inefficiencies and propose enhancements to drive scalability and consistency. Ensure alignment of feasibility processes with evolving regulatory and client requirements. People Management Support onboarding, mentoring, and capability development of new or junior feasibility team members. Foster a collaborative team culture and encourage cross-functional knowledge sharing. Provide input on resource planning and development needs within the feasibility function.

#hiring . Know anyone who might be interested? "Ahmedabad Location" Veeda Lifesciences is seeking a passionate "Business Development - Lead Generation". Experience Required: 0 to 3 Years Drop your CV to: mahendra.t3705@veedalifesciences.com Role & responsibilities: Research and Identify Prospects: Utilize various online tools, databases, and platforms to identify potential clients within the pharmaceutical, biotechnology, and medical device industries. Conduct market research to understand industry trends, competitor activities, and client needs. Develop Targeted Marketing Strategies: Collaborate with the marketing team to develop targeted campaigns and strategies aimed at generating leads. Create compelling messaging tailored to different audience segments and communication channels. Execute Outreach Campaigns: Initiate outreach campaigns through email, cold calling, social media, and other channels to engage with prospects. Follow up on leads promptly and persistently to nurture relationships and move prospects through the sales funnel. Qualify and Manage Leads: Qualify leads based on predefined criteria such as budget, timeline, and project requirements. Maintain accurate records of interactions and lead status using CRM software. Collaborate with Sales Team: Coordinate with the BD team to ensure seamless handover of qualified leads for further follow-up and conversion. Provide feedback to the marketing and sales teams on the effectiveness of lead generation efforts.

Role & responsibilities Assist in routine inspection, calibration, and preventive maintenance of lab instruments and equipment. Support troubleshooting and timely repair of laboratory machinery to minimize downtime. Maintain accurate records of maintenance activities, equipment logs, and service schedules. Ensure compliance with safety, quality, and regulatory standards within the laboratory environment. Coordinate with external vendors and service providers for specialized maintenance and calibration. Monitor lab utilities (like HVAC, water systems, and power supply) critical for lab operations. Assist in maintaining inventory of spare parts and consumables related to lab equipment. Collaborate with the lab team to ensure optimal functioning of all technical instruments.

Job Responsibilities: Design and Develop eLearning Content Create engaging, interactive modules using Articulate Storyline 360 , Rise, and other authoring tools. Design instructional materials for digital delivery, including eLearning, microlearning, and mobile learning. Translate learning objectives into meaningful content aligned with adult learning principles for Clinical research organization. Incorporate graphics, animations, videos, and simulations using Adobe Creative Suite (Photoshop, Illustrator, Premiere Pro, etc.). Test and troubleshoot SCORM/xAPI packages on LMS platforms. Collaboration with SMEs and Stakeholders Work closely with Subject Matter Experts (SMEs) to gather content and validate instructional integrity. Communicate project timelines and update progress with Seniors or Stakeholders. Instructional Copywriting & Scriptwriting Write clear and concise learning scripts, assessments, voiceover scripts, and onscreen content in coordination with Subject Matter Expert (SME). Basic LMS Knowledge (Preferred) Upload, manage, and track eLearning modules on LMS platforms like Moodle, TIMS, or Alison LMS.

Responsibility 1- Off-site Monitoring • To undertake off-site visits during different phases of study period, As per study plan conduct Initial Site Visit to train and guide site personnel. • To inspect pre-requisite as per protocol and ensure site is ready for the study, undertake routine monitoring visits at predetermined frequency as per study guideline. 2-Communication & Documentation • To communicate for Feasibility Assessment Questionnaire and fetch necessary detail for review from potential sites. • To take follow-up on routine basis with off-site nodal/in-charge, prepare visit reports (Pre-study Qualification Report, Site Initiation Visit report, Site Monitoring Visit Report, Site Closeout Visit Report) as per frequency with update of study trials and submit for review. • To procure pre-requisite documents (like calibration reports, agreements, etc) fromsites and vendor at the time of study start up and during the study. •To provide various data formats (Logs and form, Source data temples, recruitment trackers, Feasibility questionnaire etc.) to off-site team and ensure capturing/recording of data as per same. 3-Audits & Compliance • To review study related documents generated during the study in accordance with various SoPs/Protocol/Regulatory requirements. • To train/guide/mentor off-site team on study protocol/Regulatory aspects (GCP, Root Cause Analysis, updated regulatory requirements etc.) periodically. • To respond/comply to queries raised by internal (QA/QC) and external (Sponsor/Regulatory) auditors. • Any other task assigned by reporting authority.

Role & responsibilities To review & comment on the draft protocol, draft Informed Consent Documents (English ICD), draft Case Report Form (CRF) and/or associated documents received from (Medical Writer team) as per SOP and applicable regulatory guidelines. To review & comment on draft report including all appendices (Clinic related sections) and final e-CTD report received from Report writer in accordance with related SOP/regulatory guidelines/sponsor requirement. To review the respective documents as per defined timelines and/or as per the priority. To review the respective documents updated based on sponsor comment, regulatory observation and ensure compliance to the same. To responsible to review departmental Sops. To review Sponsor comments and regulatory observations and provide response within stipulated time line. Co-ordinate with team for implementing new sop in the system. Ensure that necessary corrective actions are taken for all the findings/comments/suggestions with appropriate preventive measures. Any other task assigned by reporting authority

Role & responsibilities Prepare clinical study report of BABE studies and patient based clinical trial studies (PK end point/PD end point/clinical end point studies) on the basis of data received from clinic after completion of study as per regulatory requirement/SOPs/client standards/client approved templates. Final compilation of the project report with respected appendices as per e-CTD including Module 2 (Summary report) and Module 5(Compilation of study report, literature, appendices & BR report) and/or applicable regulatory guidelines & requirements. Submit final compilation signed report with e-CTD to client. Co-ordinate with Project Manager for report requirement, sponsor's comments & response. Draft final report and submit to sponsors via project manager. Co-ordinate with BR for bio analytical report and stat for statistical report and submit sponsors via project manager.

#hiring . Know anyone who might be interested? "Bengaluru Location" Veeda Lifesciences is seeking a passionate "SPR Specialist". Experience Required: 3 to 6 Years Education Required: B pharma and M pharma Drop your CV to: mahendra.t3705@veedalifesciences.com Role & responsibilities Surface Plasmon Resonance (SPR) based studies for Drug substances and Drug products that include therapeutic peptides, therapeutic monoclonal antibodies and other therapeutic large molecules. Design and execute project experiments. Demonstrate acceptable technical/scientific skills. Adequate knowledge in various immobilization chemistries. Analyze and report the observations and conclusions. Provide rationale or hypothesis for the observations and conclusions. Work in a regulated environment and record laboratory data as per the SOPs, standards and ALCOA++ principles. Prepare or review SOPs with guidance, as required. Participate in routine lab related activities. Develop new SPR capabilities. Experience in any of the following assays will be an added advantage. Cell based flow cytometry assays Flow cytometry based immunophenotyping Flowcytometry or multiplex based cytokine analysis ADCC, ADCP and CDC assays