543 Medical Writing Jobs - Page 14

Qualifications required: M Pharm/ PharmD ONLY FOR MALE Candidates. NOTE: Only Male & Candidates from AP & Telangana Preferred. Salary- 2.2LPA (14k+ Inhand Salary 2Years Bond & Need to Submit your 10th Original Mark list with us during the Bond Period. Job description: 1. Providing inputs for the study design based on literature and prior experience. 2. Providing inputs for the preparation of protocol summaries and study protocols. 3. Plan PK analysis and concentration data checking before PK analysis. 4. Perform PK analysis using WinNonlin and applicable softwares. 5. Preparing and / or Reviewing the Protocols and Clinical study reports if required on need basis. 6. Provide justifications and responses for regulatory queries. Perform study and Pharmacokinetic investigations.

Key Responsibilities: Scientific Leadership & Stakeholder Engagement: Develop and maintain a deep understanding of the latest scientific and medical knowledge in the therapeutic area. Build and sustain professional relationships with Therapeutic Area Experts (TAEs) through impactful scientific discussions. Continuously update and map key TAEs to ensure strategic alignment. Medical Insights & Strategic Planning: Gather clinical insights from TAEs to shape Medical Action Plans, TAE Interaction Plans, and overall medical strategy. Work cross-functionally to integrate medical insights into broader business strategies. Internal Collaboration & Training: Serve as a key field-based resource for scientific and clinical expertise. Support scientific training initiatives for commercial teams to enhance their knowledge. Medical Information & Compliance: Provide evidence-based, scientifically balanced responses to unsolicited medical inquiries from HCPs. Ensure strict adherence to compliance regulations regarding medical information exchange. Clinical Research & Development Support: Assist in company-sponsored and investigator-initiated studies within the therapeutic area. Contribute to clinical research programs, national disease registries, and real-world evidence (RWE) projects. Patient Awareness & Advocacy: Support patient awareness initiatives through both physical and digital platforms. Collaborate with TAEs to enhance patient journey understanding and improve outcomes. Preferred Qualifications & Experience: Therapeutic Focus: Candidates with experience in Diabetes, Cardiology, or Cardio-Metabolic therapy preferred. Experience: 1-2 years in medical affairs, preferably as an MSL, RMA, or Medical Executive. This is an excellent opportunity to play a strategic role in medical affairs with a global pharmaceutical leader.

We are seeking a Regional Medical Advisor for a Global Pharmaceutical MNC to provide scientific expertise, medical insights, and strategic support for cardiology therapies. This role involves KOL engagement, medical affairs strategy, and market access initiatives while ensuring alignment with business objectives and healthcare policies. Key Responsibilities: 1. Scientific & Medical Expertise ? Acquire and update scientific knowledge on cardiology therapies and relevant compounds. ? Provide timely, accurate, and balanced medical information to internal and external stakeholders. ? Support the development of institutional medical plans in alignment with brand strategy. ? Assist in clinical studies, real-world data generation, and global clinical trials , including site identification and patient recruitment. 2. Key External Expert (KEE) & Stakeholder Engagement ? Identify and segment Key External Experts (KEEs) based on scientific interest and affiliations. ? Develop engagement plans with medical associations, societies, and patient support groups. ? Conduct 75% field engagement with priority healthcare professionals and key stakeholders. ? Provide medical training and scientific insights to institutional teams. 3. Government & Institutional Collaboration ? Develop and implement state-specific medical plans for government institutions. ? Represent the company at state health departments and bureaucratic bodies . ? Support policy shaping, evidence generation, and market access activities . ? Co-create value dossiers for approved indications and support their inclusion in clinical practice protocols. 4. Innovation & Market Expansion ? Partner with Innovation teams to identify and execute initiatives for disease management gaps. ? Engage in pre-launch medical activities for new products. ? Prepare and deliver scientific presentations at congresses, symposia, and medical meetings. ? Contribute to scientific literature development , including research publications and medical articles. Why You Basic Qualifications: ? BDS, MBBS, or MD qualification. ? Minimum 6 months experience in Medico-Marketing & KOL Management . ? Strong knowledge of clinical practices, cardiology therapies, and healthcare policies . ? Excellent communication and stakeholder management skills. ? Willingness to travel 30% of the time for field engagements.

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. Principal Medical Writer with specialized experience in authoring Signal Evaluation Reports (SERs), Health Authority (HA) responses, and ad hoc reports, signal management process Below are the key requirements for the role: Experience: Required at least 8+ years of experience in Safety Medical Writing with minimum of 3-4 years of experience in authoring signal Evaluation Reports, Health Authority responses, and ad hoc reports is essential. Proficiency in scientific and medical writing is a must. Demonstrated ability to produce clear, concise, and accurate documents that adhere to regulatory guidelines and internal standards. Signal Management Expertise: Familiarity with signal management principles and methodologies is highly desirable. Experience in signal detection, evaluation, and interpretation of safety data is a significant advantage Communication Skills: Excellent communication skills, both written and verbal. Proficient in scientific writing software (e.g., Microsoft Office Suite, EndNote) and data visualization tools. Familiarity with document management systems is advantageous . Education: Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.) A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

SUMMARY SAR & SAR-like Patient Safety Physician Job Description Responsible for compiling PBRERs with a focus on medical aspects and safety sections of products, and analyzing safety trends, including source data analysis based on queries Assisting in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborating with Therapeutic Head to identify signals and address product safety concerns Engaging with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensuring 100% compliance with timely completion of all client and Cognizant required trainings Achieving 100% compliance with work allocation plan, including case closure based on agreed timelines and quality benchmarks Non - Measurable Attributes Self - motivated Goal-oriented Interdepartmental collaboration Personal grooming and etiquette Punctuality Team player and process-oriented Competencies Proficient in delivering presentations Effective at collaborating across different cultures Strong preference for structured and process-driven tasks Committed to completing training and documentation on time Experience Relevant educational background and experience in patient safety or related field Required Skills Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities Requirements Requirements: Relevant educational background and experience in patient safety or related field Strong presentation and communication skills Effective intercultural work capabilities Commitment to timely completion of tasks and documentation Analytical and problem-solving skills Collaboration and teamwork abilities

Title: Lead - Regulatory Writing Date: 10 Jun 2025 Location: Bangalore, KA, IN EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD EXPERIENCE: 4 to 6 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: Lead Medical Writer is responsible for the development and review of medical writing deliverables that support the clinical regulatory writing portfolio and train the junior writers. SKILLS: Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs,) protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs) Demonstrated excellence in focused/lean writing and editing following defined processes and templates Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions Understanding of clinical development process from program panning to submission, including clinical trial design Communication skills commensurate with a professional working environment Effective time management, organizational, and interpersonal skills Customer focus Comfortable following directions, templates, and structured processes for delivering documents for review and finalization Able to work independently while maintaining communication with the Sponsor s MW project manager Ability to move across Therapeutic Areas to support business continuity and resource needs Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines Develop work plan and ensure adherence Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion Adherence to processes and Sponsor-defined best practices Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements KNOWLEDGE REQUIREMENT: Scientific Knowledge Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science Understanding of medical practices regarding procedures, medications, and treatment for different disease states Manage messaging for consistency with historical information and in alignment with agreed-upon strategy Capable of providing insight, alternatives, and suggestions based on previous experiences Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring Experience writing protocols, amendments, CSR, and CTD summary documents Technology Skills Expert authoring in MS Word, understanding of MS Word functionality Experience working in document management systems; managing workflows eApproval/signatures Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc. Flexibility in adapting to new tools and technology Capable of training writers/authors on the use of templates, guidelines, and tools RESPONSIBILITIES: Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines Develop and maintain project plans Work as an active member of cross-functional teams representing Medical Writing Coordinate and deliver document kick-off meetings with writers and cross-functional representatives Ensure adherence to standard content, lean authoring, and messaging across team members Ensure communication between members remain open and information is disseminated appropriately Possible participation in the orientation and coaching of junior team members Conduct appropriate literature searches and screening, as needed Participate on Medical Writing department initiatives, as appropriate. Research regulatory requirements to remain current in the regulatory landscape Share lessons learned and best practices Ensure compliance with company training and time reporting

Position Summary This role will be responsible for in-patient journey analysis and working with patient-level data to develop a robust solution for the client's teams. An expert in Patient Analytics who can guide and lead the team supporting pharma clients Job Responsibilities Effectively manage the client/ onshore stakeholders, as per the business needs, to ensure successful business delivery. Work closely with the project manager to define the algorithm, break down the problem into execution steps, and run the analysis Ensure high-quality analytics solutions/reports to the client Delivery role will include project scoping, solution design, execution, and communication of the analysis in the client-ready formats Contribute towards Axtria tools and capabilities as per the business requirements. Build organization capabilities by participating in Hackathon, solution design, and process automation Effectively communicate with onshore/ client (as per business needs) Education Bachelor of Engineering in Statistics Work Experience Behavioural Competencies Teamwork & Leadership Motivation to Learn and Grow Ownership Cultural Fit Project Management Communication Technical Competencies Python R SQL EXCEL MMx Forecasting Machine Learning Pharma Commercial Know How HEOR EPI and Economic Analysis HEOR Simulation Analysis Patient Data Analytics Know How Dataiku KNIME Others

. Preparation of scientific medico-marketing initiatives. . Supporting clinical research team with medical inputs . Clinical Studies/ Publications . Training & Development of sales and marketing team . Scientific Literature search Required Candidate profile MBBS + MD (Pharmacology) with 3+ years of experience. Well equipped with Communication & Interpersonal skills, making visual aids, news letters, advertisement sheet and solving scientific queries.

Role & responsibilities 1. Development and review of clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions and clinical study reports etc 2. Prepare CSRs revisions, IB updates, protocols, protocol amendments etc 3. Development and review of medical rationale for CT waiver applications 4. Support SEC meetings for clinical trials and marketing approvals by preparation of presentations & literature search 5. Work with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents 6. Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources. 7. Works closely with the study team to reach consensus on timelines for deliverables 8. Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance 9. Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes 10. Ensuring that the content, format and structure of clinical documents comply with regulatory, journal, or other guidelines 11. Reviewing and proofreading materials to check quality and scientific accuracy 12. Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system 13. Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements. Additional responsibilities 1. Development and review of clinical and non-clinical overviews and summaries of CTD 2. Development and review of marketing requests of product evaluations, comparative safety and efficacy evaluations 3. Develop manuscripts, abstracts, and PowerPoint slide decks based on in-house studies and to support marketing team. 4. Mentoring/ training team members to gain required skills to enable on-time deliverables 5. Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed 6. Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations

Description We are seeking a qualified Female Dermatologist to join our medical team in Mumbai/Pune. The ideal candidate will have 1-8 years of experience in dermatology and will be responsible for diagnosing and treating a variety of skin conditions while providing exceptional patient care. Responsibilities Conduct thorough skin examinations and assessments of patients. Diagnose and treat various skin disorders, including eczema, psoriasis, acne, and skin cancers. Perform dermatological procedures such as biopsies, cryotherapy, and laser treatments. Educate patients on skin care, treatments, and preventive measures. Stay updated with the latest advancements in dermatology and treatment techniques. Maintain accurate medical records and documentation of patient interactions. Skills and Qualifications MBBS degree from a recognized medical college. MD in Dermatology or equivalent qualification. Strong clinical skills in diagnosing and treating skin conditions. Proficiency in dermatological procedures and treatments. Excellent communication and interpersonal skills to interact with patients. Ability to work effectively in a team and handle pressure in a clinical setting. Familiarity with medical software and electronic health records.

Diensten Tech Limited is looking for Medical Safety Physician to join our dynamic team and embark on a rewarding career journey Review adverse event reports and ensure compliance with medical safety regulations Assess drug safety profiles and provide recommendations for risk management Collaborate with regulatory authorities and medical teams for patient safety Analyze clinical data to improve pharmacovigilance and adverse event reporting

Diensten Tech Limited is looking for Senior PV Specialist to join our dynamic team and embark on a rewarding career journey Monitor and assess the safety of pharmaceutical products Conduct pharmacovigilance activities and report adverse drug reactions Ensure regulatory compliance in reporting safety data Collaborate with healthcare professionals and research team

Title We are currently seeking a full-time, office-based Clinical Safety Coordinator to join our Clinical Safety department in India. This position will be focused on the handling and processing of adverse events from all sources, including clinical trials and post marketing surveillance. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Determine plan of action for incoming calls; Collect, process, and track incoming adverse and serious adverse events; Write safety narratives; Report on various safety data; and Collaborate with internal departments and investigative clinical research sites to ensure compliance with safety processes. Qualifications Bachelor's degree in Healthcare related field; Nursing, Pharmacy, Pharmacology, etc Clinical experience or Clinical Research, case processing and Post marketing Pharmacovigilance experience is preferred; Proficient English is required Proficient knowledge of Microsoft® Office; Broad knowledge of medical terminology; and Strong organizational and communication skills. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our clinical activities are growing rapidly, and we are currently seeking a full-time, office-based Data Coordinator to join our Data Management team in India, Mumbai. If you want an exciting career where you can develop and grow your career even further, then this is the opportunity for you. Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Track and maintain metrics regarding the status of the data within EDC systems Clean the clinical database, which includes generating and resolving data clarifications Reconcile clinical data Assist with support activities for the Data Management department Qualifications Bachelor’s degree in life science/ pharmacy/ health related field with strong attention to detail and working knowledge of Excel and Word; Minimum 1-2 years of clinical data management experience Knowledge of medical terminology and Clinical Research is preferred; and Good knowledge about the Clinical Databases (Medidata RAVE is preferred) People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Title Our corporate activities are growing rapidly, and we are currently seeking a full-time, office-based Data Review Associate in Mumbai, India to join our Global Clinical Coding & Support team. This position will work on a team to accomplish tasks and projects that are instrumental to the company’s success. If you want an exciting career where you use your previous nursing expertise and can develop and grow your career even further, then this is the opportunity for you! Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Responsibilities Comprehensive manual review of clinical data collected in trials Development of clinical review guidelines for specific therapeutic areas Interface with Data Management team to assure query resolution Seeking specialization in following therapeutic areas: Oncology Hematology Infectious Disease Endocrinology Metabolic disorders Qualifications Bachelor’s Degree in Nursing / Medicine, or more advanced clinical degree Professional / or Post-Qualification Nursing experience, preferably in Oncology and Hematology background General knowledge of clinical trial processes and/or experience working with clinical data Experience with using MedDRA and WHO Drug dictionaries will be a plus. People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Medpace Perks Flexible work environment Competitive compensation and benefits package Competitive PTO packages Structured career paths with opportunities for professional growth Company-sponsored employee appreciation events Employee health and wellness initiatives Awards Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

Roles & Responsibilities:- Experience in medical writing domain across different therapeutic areas in clinical documents including protocol, informed consent document, clinical study report, investigator's brochure, clinical summary of pharmacology, clinical overview (efficacy and safety); and/or safety documents like Development safety update report (DSUR), Periodic benefit risk evaluation report (PBRER), Risk Management Plans (RMPs), addendum to clinical overviews (aCOs) Experience in preparation of clinical/safety documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies preferred Experience in writing and review of scientific/clinical documents preferred Knowledge of clinical research domain, ICH GCP principles and regulatory requirements preferred Effective coordination and presentation skills - Good organization and time management skills Exceptional interpersonal, verbal and written communication skills

Roles and Responsibilities The manager-medical affairs would be required to do the following activities. Take medical trainings on the therapeutic aspects of the marketed products for the sales people. Help brand management team in creating medical communications for the doctors. Answer medical queries of the doctors related to marketed products. Preparing and delivering medical presentations in doctor CMEs. Involving in the ongoing clinical studies. The person is expected to do outstation travelling for 3-4 days in a month for company related meetings. The person should have good communication skills and should be well versed with MS Office. The person qualification should be MBBS. Postgraduation in medicinal fields (MD) would be an added advantage. Desired Candidate Profile Qualification: MBBS Experience: 1 to 6 Years

Immediate Job Openings for our Pharma Clients Job Profile Quality Assurance, Quality Control , CRA , R & D , Pharmacist , Medical Claims , Medical Record summarization , Medical Billing , Medical Writer , BDM , CDM , RA Production ,

Summary Provide expert support and functional and technical knowledge to ensure the scientific integrity/validity for clinical development, early development, and/or research projects. Participate in the full lifecycle of producing key data and/or reports in support of data review reporting development including evaluation of requirements, design specifications, interface to programmers, report programming, coordinate validation and rollout activities along with providing quantitative analytical support. Provide statistical support for regulatory submissions including planning, analysis and reporting of clinical safety and efficacy summaries. May also provide statistical support to research or other R&D areas. -Responsible for advising/leading the planning, development & implementation of Industry (CDISC and regulatory) compliant, high quality, clinical data standards, infrastructure or automation technologies. Providing expert support and stellar customer focus to business users and teams on their use, including: -Data standard collection tools in EDC (CRFs, edits checks, derivations, core configurations) -Data transfer specifications -Analysis data/TFL standards/Define -Automation solutions / technologies -Business infrastructure, business rules and guidelines. About the Role Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Represent the Biostatistics & Pharmacometrics Line Function on cross-functional teams for the assigned trials. Responsible for functional alignment and ensuring line function awareness throughout the assigned trials. Collaborate with other line functions. Explain statistical concepts in an easily understandable way to non-statisticians and provide adequate statistical justifications for actions/decisions/statements, when required. Establish and maintain sound working relationships and effective communication within the Clinical Trial Team and Biostatistics & Pharmacometrics team. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level- May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e. g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level- Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External level- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Role Requirements : MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 3+ years relevant work experience Fluent English (oral and written) Good communication and presentation skills Influences decisions that directly impact the trial/project and team ability to deliver objectives. Experience in all tasks of a statistician at the trial/experiment level and demonstrated independence in the role. Proven knowledge and expertise in statistics and its application to clinical trials; able to explain statistical designs and concepts. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e. g. SAS, R). Good knowledge of drug development and Health Authority guidelines. Demonstrated effectiveness working on a multidisciplinary team to achieve team objectives. Good understanding of Franchise/Therapeutic Area and or regulatory activities. Good project management and matrix leadership skills. Ability to collaborate well with non-statistical functions. Good business ethics Why Novartis: Commitment to Diversity and Inclusion: Accessibility and accommodation Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork. novartis. com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together? https://www. novartis. com / about / strategy / people-and-culture Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork. novartis. com/network Benefits and Rewards: Read our handbook to learn about all the ways we ll help you thrive personally and professionally:

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: Bachelor of Physiotheraphy 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 Junior Drug Safety AssociateJunior Drug Safety Associate 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 Physiotheraphy

Narayana Nethralaya is looking for Consultant Physician to join our dynamic team and embark on a rewarding career journey Consultant PhysicianDiagnose medical conditions Provide patient care Monitor treatment plans Collaborate with healthcare teams

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan 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 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 Jointly 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 Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity 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 Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai

YOUR TASKS AND RESPONSIBILITIES: Primary scientific face of the organization to Key Opinion Leaders (KOLs) physicians for a given therapy area Responsible for Identification, mapping and profiling of KOLs of given geography and therapy area, on an ongoing basis Engagement of identified KOLs through medical affairs activities, in alignment with the overall strategic plan 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 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 Jointly 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 Representing the organization in various internal external scientific platforms Gathering deep insights on disease trends and treatment patterns from key thought leaders and conveying them back to the therapy lead and commercial teams Proactively conduct disease trend analysis in identified disease segments and contribute effectively to the development of annual Medical Affairs Strategy Plan Ability to handle complex questions from health care professionals related to Sun Pharma products or disease area to satisfaction Receiving and processing scientific information requests received from physicians Ensure that all activities in the region are conducted in alignment to Sun Pharmas Global Code of Conduct and compliance guidelines Primary scientific resource for the sales team of a given therapy area, responsible for regular training and flow of latest medical developments in the given field Collaborating with KOLs to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute WHO YOU ARE: Prefer 2 years working experience in the pharmaceutical industry or research company and with competency in a project management capacity 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 Experience in medical writing preferred Integrity driven decision making skills Collaboration and teaming with ability to work in a matrix environment Strategic thinking sound analytical skills Big picture orientation with attention to detail Sense of urgency desire to excel Intellectual curiosity Self-awareness and adaptability Result oriented and performance drive Excellent interpersonal communication skills to effectively interact with a broad range of audience NOTE: The role is field-based and involves extensive travel (12 days a month) for interaction with leading KOLs and driving medical affairs activities including medical education programs, advisory board meetings, clinical studies and publications

YOUR TASKS AND RESPONSIBILITIES: Core scientific member of cross-functional franchise team and a disease area expert, responsible for scientific enablement of respective business cluster Conceptualization and project management of wide range of medical activities that are aligned to the respective franchise strategy like: New Product Ideation New Product Evaluation Therapeutic rationale relevant Medical support for regulatory submissions Preparation of SEC presentations defense in SEC meeting Pre-launch launch preparations including product monograph, training manuals, training CME slides Franchise Medical Education programs Promotional and non-promotional material review approval Answering queries Marketing and Sales training Real World Clinical Research and Publications - Planning and Execution Advisory board meetings Developing Insight driven Medical Plans Interaction Engagement of identified Key Opinion leaders in a peer-to-peer capacity through medical affairs activities, in alignment with the overall strategic plan to shape disease areas of interest A therapeutic area scientific expert, responsible for discussing the scientific data pertaining to products on proactive and reactive basis, obtain insights into patients treatment trends and insights in the disease areas of interest and to be considered a trusted scientific counterpart Responsible for identifying knowledge gaps, practice gaps and data gaps and provide recommendations for devising medical product education programs, evidence generation and special projects Ability to convert insights on disease trends and treatment patterns from KOLs into viable and formidable solutions to shape the therapeutic areas of interest Devise optimal training plan to ensure flow of latest medical developments in the given to sales marketing team Jointly responsible with marketing teams to support optimal patient outcomes through communication of data, information, and insights to shape disease areas of interest Represent the organization in various internal external scientific platforms Collaborate with thought leaders to conduct therapy specific reviews, meta-analysis, case studies, case series, patient reported outcomes and publish them in journals of repute Receiving and processing scientific information requests received from physicians internal stakeholders Ability to handle complex questions from health care professionals related to company products or disease area to satisfaction Responsible for ensuring that all promotional materials are approved within stipulated timelines and in alignment with company approval process Conduct of robust medical evaluation of new products through thorough desk research and interactions with KOLs WHO YOU ARE: Education: MD (Pharmacology) Experience: 3+ years working experience in the pharmaceutical industry or research company in a capacity of HO Medical Advisor or Sr. Medical Advisor Training in medical writing, clinical trial methodologies, research design and ICH - GCP will be added advantage Must have working knowledge of Indian regulations pertaining to Health care professionals interactions (MCI code of ethics for doctors UCPMP Code for Pharma) and Drugs and Cosmetic Act regulations pertaining to clinical trials and new drug approvals Strong academic record with deep knowledge of the therapeutic area, strength in research with knowledge of research methodologies and interpretation of medical data Strategic mindset with scientific acumen and communication skills in order to be accepted by leading specialists in peer-to-peer capacity Experience with complex business environments preferred Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and award Job Location: Sun House, Goregaon East, Mumbai