410 Drug Safety Jobs - Page 3

Division Department Sub Department 1 Job Purpose Submit product documents to regulatory authorities in accordance with country specific regulatory requirements to ensure approvals and market launch in stipulated time and handle post-approval changes, maintenance, and updation of documents during the products life-cycle Key Accountabilities (1/6) Achieve timely submission of dossier/DMF and deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time Co-ordinate with cross-functional teams and external stake-holders for query response discussion and distribute updated work plan *Create DMF master in LoA software issue LoAs/CEPs Verify pre-approved documents Leverage product gap analysis #Preparation compilation and submission of the dossier documents / deficiency responses to agency as per the region specific requirements(for Para-IV -US) Preparation of M1 documents, and collate the dossier/ deficiency responses package/DMF received from CDT and submit to the regulatory authority/customer Submit online audit dossier/DMF along with queries Key Accountabilities (2/6) Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals/Sunset clause to ensure continuous validity of marketing authorisations. Verify pre-approved documents/variation packages as received from LCM Prepare M1 documents, and collate variation packages and annual report packages received from LCM team and submit to the regulatory authority/customer Check for the MA business interest from stakeholders and progress with the renewal/ sunset clause filing Prepare labelling submission package to be in-line with RLD labelling updates and submit to the authority Prepare SPL and Drug listing for customer/launch products Key Accountabilities (3/6) Maintain, and update product dossier as required to meet changes in Cipla s internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements Review DMF and resolve discrepancies (if any) in co-ordination with CFTs Evaluate proposals related to changes (Facility change con/Notifications) and conveying line of action to manufacturing unit/relevant stakeholders. Update the database (PRC/SAP-RA/ table) associated with product dossier approvals by including registration details in database. *Attend launch meetings with internal and external stake-holders *Updating tracker for DMF number assigned by Regulatory Health Agencies and maintain the relevant data base (LOA software) upto date Notify cross-functional teams and external stake-holders about the approvals and approved documents Include and update registration details in databases (PRC/SAP-RA table/) # Provide details for APQR compilation Key Accountabilities (4/6) Provide Regulatory support throughout the life cycle of the product for smooth functioning Provide the approved product information (labelling) and the relevant documents as requested by the drug safety or quality teams Confirm product list and MA details for finalization of TA Provide the information on the suitability and availability of dossier for out-licensing and in-licensing Check the dossier information for due-diligence Perform drug listing and review labelling Key Accountabilities (5/6) Check with regulatory authorities (EU, NZ TGA) for submission activity and approval status for submission done Check with authorities for safe receipt of submitted DMF/documents as and when required Communicate to authorities for regulatory support/data requirement to get approvals Maintaining the acknowledgement letters/deficiency letters received from Regulatory Health Agency Key Accountabilities (6/6) Major Challenges Delay in the availability of the documents from cross functional teams - leads to inadherence to target deadlines Changing regulatory environment, constant updates in the regulations-leads to rework and inadherence to target deadlines Change proposals affecting dossier sections leads to leads to rework and inadherence to target deadlines Inefficient software-leads to inadherence to target deadlines Key Interactions (1/2) RnD team (for formulation clarity-need basis) Manufacturing Unit-QA/QC/Production for documents procurement -daily Packaging Team (for procurement labelling documents - dailly) CPM, BD Supply chain - for routine commercial/launch clarity (weekly basis) PV - for product approval notification and audit support (daily) Patent Team -to get the clarity on product patent and exclusivity (need basis) Key Interactions (2/2) Customers - product related queries / additional information required by customers and status updates- (daily) Regulatory consultants - submissions, queries, status (weekly) Software provider - trouble shooting (need basis) Health authorities- follow up- seek advice (need basis) Dimensions (1/2) Issuance of LoAs/CEPs: Approx. 100/Month Submission of DMFs to authorities: Approx. 14/Month Submission of AP DMFs to customer: Approx. 12/Month Legalization of documents: Approx. 20 documents /Month Dimensions (2/2) Key Decisions (1/2) Classification and type of change category for moderate and major changes confirm with group leader Key Decisions (2/2) Education Qualification B.Pharmacy, M. Pharm, Bsc or MSc Relevant Work Experience Minimum 5 years experience in regulatory activity in pharma industry preferably worked for same region/authority. Hands-on experience of eCTD submission

Eurofins Advinus is a premier preclinical and early development CRO offering drug discovery, preclinical and development stage contract research services in the areas of discovery services, regulatory Toxicology (Safety Assessment), DMPK, Analytical R&D Services and API CDMO. Eurofins Advinus manufactures drug substances to support Toxicology and early clinical studies. : Department - Discovery Qualification - MSC - Organic Chmeistry Role - Trainee Mode - Internship Stipend - 16000 Location - Hyderabad Qualifications MSC - Organic Chemistry

Job Summary We are looking for the Primary scientific face of the organization to ‘Thought Leaders’ & physicians for a given therapy area. You will be responsible for Identification, mapping and profiling of thought leaders of given geography and therapy area, on an ongoing basis. Roles & Responsibilities • You will be responsible for the engagement of identified key thought leaders through medical affairs activities, in alignment with the overall strategic plan • You will be responsible to execution of strategic medical affairs plan including but not limited to medical education, product education, medical evidence generation, advisory boards, pre-license activities and special projects • You will be a therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, patients’ treatment trends and studies in the therapeutic areas in which the Company is involved, with defined audience of leading specialists (Physicians, Pharmacists, Hospital Managers, Board Members of Scientific Societies, and other Stakeholders) and to be considered a trusted scientific counterpart • You will be responsible with therapy area lead to support optimal patient outcomes through communication of data, information, knowledge and insights in support of healthcare professional needs and organizational goals • You will have to represent the organization in various internal & external scientific platforms • You will have to gather deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams. • You will need to proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan • You will be receiving and processing scientific information requests received from physicians • You will have to ensure that all activities in the region are conducted in alignment to organisation’s COBE (Code of Business Ethics) Policy and compliance guidelines. • You will need to collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in reputed journals. • You will be responsible for devising an optimal training plan to ensure the flow of the latest medical developments to the sales and marketing teams. • You will jointly be responsible with the therapy area lead to support optimal patient outcomes through communication of data, information, knowledge, and insights in support of healthcare professional needs and organizational goals. • Representing the organization in various internal and external scientific platforms will be among your responsibilities. • You will be responsible for developing the Medical Affairs strategic plan for identified therapeutic areas and products. • Your ability to convert insights on disease trends and treatment patterns from key thought leaders into viable and formidable strategic plans to shape the therapeutic areas of interest will be vital. • You will be responsible for identifying knowledge gaps, practice gaps, and data gaps and developing strategic medical action plans, including but not limited to medical education, product education, evidence generation, and special projects, will fall under your responsibility. • Collaborating with thought leaders to conduct therapy-specific reviews, meta-analysis, case studies, case series, patient-reported outcomes, and publishing them in reputable journals will be part of your role. • Handling complex questions from healthcare professionals related to GGI products or disease areas to satisfaction will be a key responsibility. • You will be responsible for ensuring that all activities in the therapeutic area are conducted in alignment with Dr. Reddy's COBE (Code of Business Ethics) Policy and compliance guidelines will be essential. • You will be responsible for ensuring that all promotional, physician, and patient education materials are approved within stipulated timelines and in alignment with Dr. Reddy's Promotional Material approval policy. • As a product pipeline champion, you will have the ability to identify unmet needs through active stakeholder interactions and actively contribute to the new product ideation and development of differentiated products. Qualification Educational Qualification- MBBS with full time post-graduate qualification of at least 2-years’ duration in any discipline of medicine/ M.B.B.S with M.B.A. from a reputed institute Minimum work experience- Fresh postgraduate or up to 2 years of experience in Field based Medical Affairs . Skills & attributes – Good understanding of therapy area - Oncology Abiity to read and interpret the clinical trails Knowledge about business landscape. Technical Skills • Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data • Experience with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer relationship • Experience with complex business environments preferred • Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards. . Additional Information About the Department Global Generics India Global Generics India business journey began in 1986. In the last three decades, we have grown as a trusted name in the healthcare industry and rank as one of the top 10 Pharma Companies in the Indian Pharma Market (IPM) as per IQVIA MAT (November 2022). Our commitment to Lead Ahead has helped us move ranks from 16th position to 10th position (IPM) in the last four years. We are a fast-growing organisation with double-digit growth and significant market share in domestic markets. Currently, we rank among the top 5 in oncology, anti-allergy and gastrointestinal diseases and the top 10 in a few other therapy areas. Our focus is on leveraging our digital capabilities, collaborations, innovations and inorganic opportunities to become the top 5 companies in the Indian Pharma Market. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Responsible for handling end to end Case management (ICSRs) activities and to ensure the compliance. Manage assigned team and ensure that all tasks are performed according to guidelines and standard operating procedures. Consulting and guiding the pharmacovigilance team for completion of aggregate reports (PSURs, PADERs, RMPs and applicable regulatory submission PV documents) as required for regulatory submission To develop and review pharmacovigilance SOPs. Coordination with MICC for ICSR activities and regulatory compliance. Coordinating the safety data exchange agreements between Hetero and business partners. Responsible for providing guidance and training to team as and when required. Responsible for identifying, implementation and continuous improvement activities. Responsible to handle audits and inspections

at least 3 months internship at hospitals B.pharm, diploma/ certification in Clinical Research, good to done internship for few months at any hospital, good communication skills, can speak Infront of doctors or in chamber of doctors JD: Done feasibility start -up activities till Site initiation

5 yrs experience on global clinical trials, including CRC CRA experience Having CRA team management experience must JD: Offer handholding to CRC's, stie start up specialist for activities like identifying potential doctors to close out of the trial from end to end all trial conduct activities Onsite visit for purpose of SIV, IMV, Close out visit, any audits by stakeholders Market research of feasible hospitals Area: Nagpur, Raipur, Aurangabad, Pune

2 yrs CRC experience/ Bpharm, Mpharm/Bpharm,MBA qualification, fresher or intern in any pharmaceutical marketing/ Worked as Placement Coordinator for pharmacy college, Good Communication, Interpersonal analytical skills , establish Relationship with colleges, their placement cell, faculties, managing relationship with hospitals Doctors/investigators, handling grievance, helping out MD of company for developing patient data base, handling placement Drive event related things, establish follow up communication with CRO's/ Sponsor/hospitals IT companies regarding same.

Urgent Clin Infotech Hiring B.Pharm Freshers With Certification in Clinical Research and Clinical Data Management Candidate With Hands On Experience In Clinical Data Management Is Preferrable Required Candidate profile Candidate With Knowledge in Clinical Research Roles and Responsibilities is Prefferable Candidate Should have Good Communication Skills is Mandatory

We are seeking an experienced Drug Safety Coding Specialist with a strong background in pharmacovigilance terminology and regulatory coding standards. Roles and Responsibilities Perform accurate and consistent coding of adverse events , medical history, lab terms, and concomitant medications using MedDRA and WHO-DD. Review and validate terms in Individual Case Safety Reports (ICSRs) to ensure alignment with global PV standards. Perform recoding or dictionary version updates in compliance with regulatory requirements. Collaborate with case processors, medical reviewers, and data management teams to resolve coding discrepancies. Ensure compliance with ICH-GCP , GVP , and internal SOPs. Maintain and update code lists and contribute to coding conventions development. Support training of new team members on dictionary use and coding best practices. Participate in audits, inspections , and quality control checks related to coding. Qualifications B.Pharm / M.Pharm / PharmD / MBBS / BDS / B.Sc. Life Sciences MedDRA coding training or pharmacovigilance certification is a plus Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/WhatsApp to 9342735755

Roles and Responsibilities Prepare and review high-quality aggregate safety reports for regulatory submissions. Author and update Risk Management Plans, Core Safety Information, Company Core Data Sheets, and Safety Narratives. Collaborate with global cross-functional teams including pharmacovigilance, medical affairs, regulatory, clinical, and biostatistics. Interpret and summarize safety data from various sources including clinical trials, real-world evidence, and post-marketing surveillance. Track timelines and ensure timely delivery of all safety documents. Qualifications PharmD / M.Pharm / MBBS / BDS / MSc in Life Sciences or Pharmacology Certification in medical writing, regulatory affairs, or pharmacovigilance is an added advantage Strong analytical and problem-solving skills Excellent communication and interpersonal skills Ability to work independently and as part of a team Interested to apply can share CV or call/WhatsApp to 9342735755

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Pharmacy/Bachelor of Physiotheraphy/BSc. Nursing 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 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.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 Ability to work well in a teamAgility for quick learningAdaptable and flexible 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,Bachelor of Physiotheraphy,BSc. Nursing

Skill required: Pharmacovigilance Services - Safety Writing Designation: Pharmacovigilance Services Sr Analyst Qualifications: Bachelor of Pharmacy Years of Experience: 5 to 8 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. What are we looking for Ability to establish strong client relationship Roles and Responsibilities: In this role you are required to do analysis and solving of increasingly complex problems Your day to day interactions are with peers within Accenture You are likely to have some interaction with clients and/or Accenture management You will be given minimal instruction on daily work/tasks and a moderate level of instruction on new assignments Decisions that are made by you impact your own work and may impact the work of others In this role you would be an individual contributor and/or oversee a small work effort and/or team Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank. The ideal candidate will have 2-3 years of experience in the BFSI industry, preferably with a background in risk management or a related field. Roles and Responsibility Conduct thorough analysis of customer data to identify potential risks and develop strategies to mitigate them. Collaborate with cross-functional teams to implement effective risk management plans and monitor their progress. Develop and maintain relationships with key stakeholders, including customers, vendors, and internal teams. Identify and assess new business opportunities and provide recommendations for growth and expansion. Stay up-to-date with industry trends and regulatory requirements to ensure compliance and minimize risk. Provide expert guidance on risk management best practices to junior team members. Job Requirements Strong understanding of risk management principles and practices, with a focus on asset management and risk containment. Excellent analytical and problem-solving skills, with the ability to interpret complex data sets and make informed decisions. Effective communication and interpersonal skills, enabling strong collaboration with diverse stakeholders. Ability to work independently and as part of a team, demonstrating a flexible and adaptable approach to changing priorities. Strong knowledge of financial regulations and industry standards, with a commitment to ongoing professional development. Proficiency in Microsoft Office and other relevant software applications, with excellent time management and organizational skills.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

B.Pharmacy Freshers With SAS Training 2023 & 2024 Passouts Only are Eligible Must have Completed SAS Training With good Knowledge in SAS SDTM, Tables & Listing, Adams and Macros. Understanding of relational data base structure & data systems. Required Candidate profile Review protocols for completeness, appropriateness of clinical design and sound statistical analysis. Develop statistical analysis plans, including table, listing and graph specifications.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Functional Responsibility Having sound knowledge of banking domain (Wholesale, retail, core banking, trade finance) In-depth understanding of RBI Regulatory reporting and guidelines including RBI ADF approach document. Should have experience in handling various important regulatory returns like Form- A, Form VIII (SLR), Form X, BSR, SFR (Maintenance of CRR) ,DSB Returns, Forex, Priority sector lending related returns to RBI Should have an understanding of balance sheet and P&L. Supporting clients by providing user manuals, trainings, conducting workshops and preparing case studies. Process Adherence Review the initial and ongoing development of product Responsible for documenting, validating, communicating and coordinating requirements. Provide support to business development by preparing proposals, concept presentations and outreach activities Maintaining and updating tracker, reviewing test cases, providing training to internal as well as external stakeholders Client Management / Stakeholder Management Interact with clients in relation to assignment execution and manage operational relationships effectively Interact with client for requirement gathering, issue tracking, change request discussion, FRD writing and preparing project status reports People Development Co-ordinate with assignment-specific team of consultants, developers, QA and monitor performance to ensure timely and effective delivery

Job Type: Part-Time / Hourly -Remotely from anywhere across India / Globally. We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital or in a startup /mid-size company/ MNC / Top Onco Pharma MNC. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology practice or Medical Oncology Research/Onco Surgeon from reputed Medical University & Hospital. Experience : 5 - 25 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS OR Post MSc, PhD in Medical Oncology by Research from Reputed Medical Research University needs to apply.

Job Type: Part-Time / Hourly -Remotely from anywhere across India / Globally. We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.

Job Type: Part-Time / Hourly -Remotely from anywhere across India / Globally. We are currently looking for Medical Oncologist with strong experienced in Medical Oncology with an entrepreneur mindset prepared to work in a collaborative Team as our Internal Team member / Partner/ External Partner / having busy Medical Oncology Practices handled atleast 100-10000's of Cancer Patients ( In top 20 Cancers) in his experience with a reputed Medical Research University & Hospital. Qualification : 1) MBBS with DNB / MD /MS/Mch with specialization in medical Oncology or Medical Oncology Research / Onco Surgery / Radiation Oncology / Hemato Oncology from reputed Medical University & Hospital. Experience : 5 - 30 Years experience in medical Oncology Practice or Cancer Medical Research Post MBBS, MD /MS / Mch from Reputed Medical Research University & Hospital needs to apply. - Eligible Professional may apply to this job opportunity along with CV with passport size photo, your medical Practice / Research area.