279 Medical Writing Jobs - Page 3

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Master of Pharmacy Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do 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 Affiliate Team AssociateAffiliate Team Associate Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy,Master of Pharmacy

Skill required: Pharmacovigilance Operations - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services New Associate Qualifications: BSc/Bachelor of Pharmacy Years of Experience: 0 to 1 years Language - Ability: English(International) - Proficient 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 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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines. 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. 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 BSc,Bachelor of Pharmacy

QC and formatting of clinical trial protocols, informed consent forms (ICFs), clinical study reports (CSRs), investigator’s brochures (IBs), and clinical data summaries for phase 1-phase 3 and post-marketing surveillance studies and as per agreed timelines. QC and formatting of clinical modules of eCTD dossiers for global approval in developed and emerging markets with high quality and as per agreed timelines. Ad-hoc writing support for clinical documents such a ICFs, CSRs and protocols CSR publishing for regulatory submissions. Ad hoc QC and formatting support for cross-functional teams in Medical Affairs and Clinical Development Support in creating and/or updating SOPs, checklists, and templates. Work collaboratively with other medical writers and cross-functional stakeholders within the Clinical Development function. Support Group Lead in maintaining and tracking medical writer occupancy and resourcing Qualification M Pharm with minimum 5 years of experience in document QC and formatting within the pharmaceutical industry Excellent written, spoken, interpersonal and presentation skills Proficiency in editing and formatting documents using Microsoft Office and Acrobat. Good understanding of medical terms, clinical trials, and drug development process. Ability to analyze and interpret scientific and medical data Highly detailed orientated and excellent time management skills Additional Information About the Department Biologics Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10–15-year time horizon. With a robust portfolio of biosimilar products across key therapeutic areas, covering ~US$80+ Bn in innovator sales – future business pipeline covers a variety of product classes and therapy areas, and new modalities. Fully integrated organization with over two decades of experience in developing, manufacturing and commercializing multiple biosimilar products. With a Product Development engine that has end-to-end capabilities – in-house clone development, upstream and downstream process development, bioanalytical development and proprietary formulation. Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs. We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure Rich experience of commercializing high-quality biosimilars in multiple markets with over 900,000 patients having benefited from our products till date. 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/#!/

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy Years of Experience: 1 to 3 years Language - Ability: English(International) - Advanced About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do 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.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.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. What are we looking for 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.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. Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification Bachelor of Pharmacy

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance 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.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.In this role, you will be expected to create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for Ability to establish strong client relationshipAbility to work well in a teamCollaboration and interpersonal skills 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

Watson Pharma Private Limited. is looking for Medical Writing Associate to join our dynamic team and embark on a rewarding career journey Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Preparation of operating budgets, financial statements, and reports. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processe

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Job Function: Data Analytics & Computational Sciences Job Sub Function: Biostatistics Job Category: Scientific/Technology All Job Posting Locations: Bangalore, Karnataka, India, Mumbai, India, PENJERLA, Telangana, India Job Description: Principal Responsibilities: Designs and develops statistical programs in support of clinical research analysis and reporting activities. Performs appropriate quality control and verification in support of assigned clinical research analysis and reporting activities. Maintains statistical programming documentation as appropriate. Completes programming tasks of medium to high complexity with high quality and timeliness of deliverables. Performs activities in compliance with departmental processes and procedures. Collaborates effectively with statistical programming and cross-functional team members and counterparts to achieve project goals. Critically reviews requirements and data, identifies gaps, proposes solutions, and applies expertise to improve efficiency of programming tasks and/or improve overall quality of programming deliverables. Ensures continued compliance with required company and departmental training, time reporting and other business/operational processes as required for position. May contribute to departmental innovation and process improvement projects. Principal Relationships: Reports into people manager position within the functional area. Accountable to the Programming Lead for assigned programming activities Functional contacts within IDAR include but are not limited to, Statistical Programming Portfolio Lead, Programming Lead, peer groups within the function, Data Management, Regulatory Medical Writing. Functional contacts within Janssen (as collaborator or peer) include but are not limited to Quantitative Sciences, Biostatisticians, Clinical - Primary interfaces within clinical project (trial), program, and submission teams. External contacts include but are not limited to external partners including CROs. Qualifications - External Bachelor s degree or higher and/or equivalent in computer science, mathematics, data science/analytics, public health or other relevant scientific field (or equivalent theoretical/technical depth). Approximately 4-6+ years relevant programming experience with increasing responsibility, preferably in a pharmaceutical/Clinical R&D environment or field. In depth knowledge of data structures and relevant statistical programming languages. May include SAS, R, Python etc. Knowledge of SAS and R preferred. Working knowledge of processes and concepts relevant to Statistical Programming. Basic knowledge of relevant regulatory guidelines (e.g. ICH-GCP) and relevant clinical R&D concepts. Demonstrated written and verbal communication skills. Experience working in a team environment.

Skill required: Com.Bkg- Commercial Real Estate - Real Estate Due Diligence Designation: Banking Advisory Associate Qualifications: BCom/MCom/Master of Business Administration Years of Experience: 1 to 3 years About Accenture Combining unmatched experience and specialized skills across more than 40 industries, we offer Strategy and Consulting, Technology and Operations services, and Accenture Song all powered by the worlds largest network of Advanced Technology and Intelligent Operations centers. Our 699,000 people deliver on the promise of technology and human ingenuity every day, serving clients in more than 120 countries. Visit us at www.accenture.com What would you do We help clients address quality and productivity issues, keep pace with customer expectations, navigate regulatory and operational pressures and ensure business sustainability by transforming their banking operations into an agile, resilient operating model.The Corporate banking /Wholesale banking team is responsible for helping clients and organizations processes trade finance transactions by providing superior service delivery to trade customers whilst safeguarding the bank from risks associated with this business.Identify and assess, prevent and mitigate and account to provide reasonable measures to adapt before executing an agreement in relation to the real estate and immovable property. Valuation of commercial real estate using software like Argus, extracting key information from lease agreements (including amendments) and rent rolls. What are we looking for Adaptable and flexibleAbility to perform under pressureAgility for quick learningAbility to work well in a teamCommitment to quality Roles and Responsibilities: In this role you are required to solve routine problems, largely through precedent and referral to general guidelines Your expected interactions are within your own team and direct supervisor You will be provided detailed to moderate level of instruction on daily work tasks and detailed instruction on new assignments The decisions that you make would impact your own work You will be an individual contributor as a part of a team, with a predetermined, focused scope of work Please note that this role may require you to work in rotational shifts Qualification BCom,MCom,Master of Business Administration

Long Term Disability Claim Manager Role Overview: The LTD Claim Manager will manage an assigned caseload of Long Term Disability cases. This includes management of claims with longer duration and evolving medical conditions. LTD Claim Managers will have meaningful and transparent conversations with their customers and clinical partners in order to gather the information that is most relevant to each claim. It also requires potentially complex benefit calculations on a monthly basis. The candidate will also evaluate customer eligibility and interact with internal and external customers including, but not limited to, customers, employers, physicians, internal business matrix partners and attorneys etc. to gather the information to make the decision on the claim. What You'll Do: Proactively manage your block of claims by regularly talking with and knowing your customers, their level of functioning, and having a command of case facts for each claim in your block Develop and document Strategic Case Plans that focus on the future direction of the claim using a holistic viewpoint Find customer eligibility by reviewing contractual language and medical documentation, interpret information and make decisions based on facts presented Leverage claim dashboard to manage claim inventory to find which claims to focus efforts on for maximum impact Have discussions with customers and employers regarding return to work opportunities and communicate with an action-oriented approach. Work directly with clients and Vocational Rehabilitation Counselors to facilitate return to work either on a full-time or modified duty basis Ask focused questions of internal resources (e.g. nurse, behavioral, doctor, vocational) and external resources (customer, employer, treating provider) in order to question discrepancies, close gaps and clarify inconsistencies Network with both customers and physicians to medically manage claims from initial medical requests to reviewing and evaluating ongoing medical information Execute on all client performance guarantees Respond to all communications within customer service protocols in a clear, concise and timely manner Make fair, accurate, timely, and quality claim decisions Adhere to standard timeframes for processing mail, tasks and outliers Support and promote all integration initiatives (including Family Medical Leave, Life Assistance Programs, Integrated Personal Health Team, Your Health First, Healthcare Connect, etc.) Clearly articulate claim decisions both verbally and in written communications Understand Corporate Compliance, Policies and Procedures and best practices Stay abreast of ongoing trainings associated with role and business unit objectives What You'll Bring: High School Diploma or GED required. Bachelor's degree strongly preferred. Long Term Disability Claims experience preferred. Experience in hospital administration, medical office management, financial services and/ or business operations is a (+) Comfortable talking with customers and having thorough phone conversations. Excellent organizational and time management skills. Strong critical thinker. Must be technically savvy with the ability to toggle between multiple applications and/ or computer monitors simultaneously. Ability to focus and excel at quality production Proficiency with MS Office applications is required (Word, Outlook, Excel). Strong written and verbal skills demonstrated in previous work experience. Specific experience with collaborative negotiations. Proven skills in positive and effective interaction with customers. Experience in effectively meeting/exceeding personal professional expectations and team goals. Must have the ability to work with a sense of urgency and be a self-starter with a customer focus mindset. Comfortable giving and receiving feedback. Flexible to change. Demonstrated analytical and math skills. Critical Competencies: Decision Quality Communicate Effectively Action Oriented Manages Ambiguity Customer Focus

Shubham Hospitals, Varanasi is looking for Medical Officer Senior to join our dynamic team and embark on a rewarding career journey. Diagnosing and treating patients' illnesses and injuries. Creating and maintaining patient medical records. Prescribing medication and therapies. Ordering and interpreting diagnostic tests. Referring patients to specialists as needed. Developing and implementing treatment plans. Educating patients about their health conditions and treatment options. Working closely with patients and their families, as well as other healthcare professionals.

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. The SMW will be responsible for authoring the signal management reports including Validations, SERs, HA requests etc. The scientist will support early and late phase development activities as a member of the safety team, providing essential safety oversight and input into all aspects of study management across the entire development and marketed portfolio. In the post-market setting this may include and may include signal evaluation, safety related activities associated with new drug applications/regulatory filings, benefit-risk assessment and safety risk management Perform signal detection review and analysis (qualitative and quantitative) from various sources e.g. regulatory authority database, client database, literatures, regulatory authority websites etc. Responsible for the end-to-end signal management process (i.e. signal tracking, signal assessment/data analysis, leading review meetings, presenting, etc.) in collaboration with the GSO. Conduct/support signal detection and evaluation activities according to SOPs and guidelines Maintaining a good working knowledge of the adverse event safety profile of the assigned drugs, labeling documents, client’s guidelines, procedures and SOPs, and international drug safety regulations Maintaining an awareness of global regulatory reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for the adverse event reporting Maintaining a good working knowledge of the assigned Clinical studies for narratives Attending/conducting internal, drug safety and project specific training sessions Imparting trainings to the new starts during the induction sessions and the team as required. Skills: Analytical and problem-solving skills Excellent interpersonal skills Excellent verbal / written communication skills Excellent organizational and prioritization skills Ability to work collaboratively and effectively in a team environment Client focused approach to work Ability to evaluate data and draw conclusions independently A flexible attitude with respect to work assignments and new learning Ability to negotiate on behalf of the department to ensure resources, timelines and expectations are aligned Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail Fluency in written and spoken English Computer proficiency, IT skills, the expertise and an ability to work with web-based applications, and familiarity with the Windows Operating system and the MS Office suite (Word/Excel/Power Point) Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities. Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text Typing and transcription accuracy Knowledge and Experience : Relevant experience is desirable in Regulatory/ Pharmacovigilance or related field. Good knowledge of medical terminologies 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

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.