279 Medical Writing Jobs - Page 2

Role & responsibilities: Minimum 2 - 3 years of medical writing work experience including 1 to 2 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) To perform all pre-DLP activities and planning for all assigned reports as per client instructions and timelines including the conducting of strategy meeting, kick-off meetings and other ad hoc report related meetings. Performs activities related to the preparation, writing and review of safety portions of Periodic Aggregate Safety Reports (PBRER, DSUR etc.). To perform compilation of all global and country specific periodic aggregate safety reports assigned by the supervisor. To perform peer review of the assigned periodic safety report and complete the corresponding QC checklists within the assigned timeline. To track and drive the progress of safety periodic reports as per the client defined timelines. To ensure compliance to SOPs (client e-manuals and training modules) and other process related documentation.

Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do so #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together Primary Responsibilities: Review and analyze patient medical records for accurate code assignment Ensure adherence to coding guidelines and regulatory requirements Learn to use medical coding software Apply understanding of anatomy and physiology to interpret clinical documentation and identify applicable medical codes Stay updated on industry changes and attend relevant training sessions Ensure confidentiality and security of all patient information Comply with the terms and conditions of the employment contract, company policies and procedures, and any and all directives (such as, but not limited to, transfer and/or re-assignment to different work locations, change in teams and/or work shifts, policies in regards to flexibility of work benefits and/or work environment, alternative work arrangements, and other decisions that may arise due to the changing business environment). The Company may adopt, vary or rescind these policies and directives in its absolute discretion and without any limitation (implied or otherwise) on its ability to do #NTRQ Required Qualifications: Bachelors degree or masters degree, from a medical science backdrop or anything relevant Life Science or Bioscience, Pharmacy or Pharmaceutical Sciences, Nursing or Medicine Allied Health Good knowledge in medical terminology basics Good knowledge in Anatomy physiology basics Well-versed with ICD-10 guidelines and their implementation Proficient in reviewing medical records and determining the accuracy and completeness of the document Preferred Qualifications: AAPC/AHIMA Certification Risk Adjustment coding experience At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone of every race, gender, sexuality, age, location and income deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes an enterprise priority reflected in our mission.

Responsibilities: Review client case information and determine required medical records and facilities involved. • Initiate medical record requests via fax, email, portals, or telephonic communication in compliance with HIPAA and client-specific protocols. • Regularly follow up with hospitals, clinics, and third-party record retrieval services (e.g., MRO, CIOX) to track the status of requests. • Escalate delays, incomplete records, or denials to appropriate stakeholders and take corrective action. • Update internal tracking systems, logs, and client databases (e.g., Clio, Filevine, Needles) with current status and notes. • Communicate professionally and clearly with providers, clients, and internal teams via email and calls. • Perform quality checks to ensure completeness and accuracy of received records before submission to legal teams. • Maintain turnaround time (TAT) and service level agreements (SLAs) for all assigned cases. • Review and analyze scanned medical records and bills and summarize them as per the guidelines. • Create concise and accurate summaries of patient medical histories, procedures, diagnoses, and treatment plans for internal use and billing purposes. • Maintain organized records of summarized information, ensuring compliance with legal and regulatory standards. Preferred Tools & Platforms Experience (Mandatory): • Clio, Filevine, Litify, or Needles • Record retrieval platforms (CIOX, MRO, ChartSwap, Sharecare) • SharePoint, Dropbox, Google Drive • Nitro, Microsoft word, excel, outlook. Key Skills: Strong understanding of medical terminology. Excellent written communication skills with attention to detail. Proficiency in Microsoft Office Suite and electronic health record (EHR) systems. Preferred Candidate Profile Bachelors degree in life sciences is mandatory (BPT, MPT, BAMS, BHMS, BUMS, and BDS) Should have proficiency in Typing (30 WPM with 97% of accuracy) Should be flexible with 24*7 shift. Freshers can apply. Package: ~ 3.16 LPA for Freshers ~ up to 4.2 LPA for experienced Preferred Candidate Profile: Graduation is mandatory Should be flexible with 24*7 shift. Learning Opportunities Freshers can also apply, must have knowledge about medical terminologies Great work culture Positive Work Environment Immediate Joiners only *** Walk In Details Venue - Provana, A-5 Sector 6 Noida. Time - 10 AM IST Date - 21th June 2025 (SATURDAY) HR Reference : YAMINI MOURYA || PINKI JHA

Job Role: Review, edit, and format research papers for publication. Ensure grammatical accuracy, clarity, and proper citation styles. Coordinate with authors and researchers for revisions. Maintain publication standards and adhere to journal guidelines. Assist in proofreading and finalizing manuscripts. Work with MS Word and other editing tools to enhance document presentation. Skills Required: Strong English writing and editing skills. Attention to detail and accuracy in formatting. Proficiency in MS Office (Word, Excel).

Oversee the maintenance of patient medical records. Ensure accuracy and confidentiality of medical records. Coordinate with other departments for record retrieval. Train and supervise medical record staff. Implement and enforce record-keeping policies.

Work closely with Senior director (EBM strategic planning and operations), business partners, therapy areas lead, eBuy manager, external vendors, and finance colleagues to support coordination and management of various activities Work with TA Leads to conduct monthly/bimonthly/quarterly budget reviews and ensure full oversight; identify US budget needs; coordinate with cross-functional teams to operationalise strategic plan, brand plan and prioritization; identify areas of support needed; develop and maintain TA project tracker; to track and update on monthly worksheet issues flagged Work with business partners to perform monthly review of budget plans and actuals; complete North America (NA) intake form and update budget tracker with SOW details, shift funds on tracker to align with finance; provide updates on pending contracts, identify any challenges and follow-up on invoicing issues; follow-up on cross charges by end of November to make sure they hit the books; coordinate and assist to set-up Ad-board meetings Coordinate with ITA team for organising external meetings and activities such as GRFs, FMVs, tiering, honoraria tables and cost-sheet etcCoordinate with finance colleagues to communicate any discrepancies between finance trackers and BPs budget tracker, cost centre mistakes and for any amendments as needed Work with vendors on contract support to onboard vendors; ensure final approved SOW is processed via NA Intake form, follow-up on contract and PO, forward PO to vendor; support with contract renewals or amendments; follow-up on PV training; monitor invoices to be processed; schedule meetings and prepare meeting minutes Responsible for project management support to the scientific writer and HEVA ensuring the end-to-end effective project delivery of the designated publication/medical education and HEVA deliverable across all phases Initiate submission (as required), amend submission based on comments (as required). Support the writer with the development of a scope of work; build plan and schedule for agreement with the internal stakeholders Arrange key internal and external stakeholder meetings. Track the delivery of activities (including managing issues and risks) and support follow up Support tracking GD requests and ensuring they are executed on time Support in and maintaining and tracking editorial and QC request for publications and other deliverables. Also make sure stipulated timelines are met Support required submission, compliance, and approval activities, and ensure compliance with publication processes and use of publication management tools Support the management of the assigned publication or medical education in line with the agreed budget. Support and manage as required external spend tracking (eg, approvals, purchase orders, and goods received) Support HEVA team in fetching articles from Rightfind or relevant scientific databases Support HEVA team members in sourcing full texts of paid articles from other sources and managing their procurement processes as per the standard guidelines Support HEVA team in downloading and categorisation of booklets and information, respectively, from various congress websites as per the eligibility criteria Support adherence to associated compliance related activities and approvals (with internal stakeholder taking accountability for compliance) Update as required with approval/compliance tools (eg, PromoMats, NAYA) Manage end to end process through Datavision, Matrix, RightFind, Ebuy, PrismAccess, etc Collaborate effectively with stakeholders: Scientific communication global and/or local teams/HEVA teams; and medical content enhancement teams People: (1) Maintain effective relationship with the end stakeholders (medical scientific community) within the allocated GBU and product - with an end objective to develop education and communication content as per requirement; (2) Actively lead and develop SGH operations associates; (3) Ensure new technologies are leveraged; (4) Support vendor engagements, advisory boards scientific events activities & external expert contracts; (5) Initiate the contracting process and related documents within defined timelines; and (6) Collaborate with global stakeholders for project planning and setting up the timelines and maintaining budget Performance: 1) Coordinate all contracting and budgeting tasks diligently (2) Work with HEVA TA Leads to conduct monthly/bimonthly/quarterly budget reviews and ensure full oversight (3) Work with business partners to perform monthly review of budget plans and actuals (4) Coordinate with ITA team for organising external meetings and activities (5) Coordinate with finance colleagues to communicate all discrepancies (6) Ensure publication/medical education materials (slide decks, abstracts, posters, manuscripts, newsletters, pub alert, etc) are delivered, stored as per agreed timelines and quality; (7) Develop tools, technology, and process to constantly improve quality and productivity; (8) Support SGH HEVA team in timely review and audit of all DataVision entries; (9) Support SGH HEVA team in all operations related projects; (10) Perform quality check for HEVA documents; (11) Maintain HEVA Smartsheet/projects trackers as needed and make sure all entries are up to date for all projects and; (12) Support global HEVA team to maintain trackers and facilitate retrieval of required information for business reviews as needed (13)Work with vendors on contract support to onboard vendors Process: (1) Support delivery of projects in terms of resourcing, coordination, quality, timeliness, efficiency, and high technical standards for deliveries made by the medical writing group, including scientific documents and clinical/medical reports; (2) Contribute to overall quality enhancement by ensuring high scientific standards for the output produced by the medical writing group; and (3) Secure adherence to compliance procedures and internal/operational risk controls in accordance with any and all applicable regulatory standards Stakeholder: Work closely with scientific communication/medical content enhancement/HEVA teams/finance teams and external vendors to ensure the end-to-end effective project delivery of the designated publication/medical education deliverables About you Experience : Medical communication/pharma experience desirable. Project management experience required. 3-5 years post qualification experience. Project management/medical communication/pharma experience desirable. Soft skills : Stakeholder management; writing/communication skills; external engagement and ability to work independently and within a team environment Technical skills : Contracting, budgeting, vendor management, including but not limited publication ops support; and/or project management Education : Advanced degree in life sciences / commerce / engineering / pharmacy / similar discipline Languages : Excellent knowledge of English language (spoken and written)

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 Commitment to Diversity and Inclusion: Accessibility and accommodation 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:

Job description : Lead the preparation and review of aggregate safety, risk management, signal detection, and benefit-risk evaluation reports Demonstrate the ability to independently manage the production of safety deliverables, including those involving complex data analyses or important safety issues Act as a technical lead of the medical writing teams across projects and provide guidance and expertise for developing high-quality scientific content as required for various safety deliverables Establish good client communication and coordination within writing teams to manage stakeholder expectations and resolve any issues surrounding project/report deliverables Contribute to scientific publications and represent the company at scientific meetings and conferences Work with the project management team to implement quality and process improvement initiatives Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time. Summary of Responsibilities: Write and review various safety reports for global regulatory submissions for clients, including but not limited to Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Report, Clinical Overviews, Medical Device reports, and other documents as assigned. Lead the end-to-end process of report production and ensure the required quality standards and key timelines are met. Provide oversight to co-authors or team of writers as applicable and be accountable for the quality of their work/contributions. Act as the primary point of contact for the client for all report management activities. Engage in client communication to manage stakeholder expectations, present anticipated challenges, propose remediation, and escalate unresolved issues impacting deliverables at an individual report or project level. Author/review RMPs, ad hoc reports, Benefit-Risk Evaluation reports, supporting documents for label updates, reports of effectiveness of risk minimization measures or enhanced pharmacovigilance activities. Lead/participate in various steps of the signal management process. Provide inputs for developing signal strategies and retrieval of data from safety databases, scientific literature, and other sources, as required. Author/review signal evaluation/management reports (ad hoc and periodic) and safety issue analysis reports. Participate in safety/benefit-risk review meetings with clients, discuss results and conclusions from signal/safety analysis, and in collaboration with the safety physician, propose label updates and other risk mitigation measures, as needed. Draft responses (or parts thereof) to health authority questions or feedback and collaborate with cross functional stakeholders in the management and tracking of such feedback. Develop abstracts, posters, manuscripts, and other documents for scientific publication or presentation at conferences or pharmacovigilance forums. Prepare medical information responses for HCPs. Act as a writing coach, provide regular quality feedback, conduct training, and share best practices with associates for promoting the use of clear and concise writing and adherence to style guides, as applicable. Support project management activities such as maintenance of project schedules and tracking of metrics and compliance. Contribute to business development activities, including estimation of resource requirement and responding to RFPs. Create and update labels, e.g. Core Data Sheets, USPI, centralized SPC s, Med Guides. Conduct literature reviews, formulate and execute search strategies, including those for complex topics or research questions. Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures and assume accountability for the deliverables. Ensure compliance of operations with governing regulatory requirements. Create, maintain, and assume accountability for a culture of high customer service. Perform any additional activities per project requirement or at the manager s discretion upon completion of relevant training. And all other duties as needed or assigned. Qualifications (Minimum Required): Minimum of first degree in life sciences (or equivalent). Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Experience (Minimum Required): At least 5-7 years of experience in the pharmaceutical industry, with at least 4 years of it in medical writing. Excellent command of written and spoken English. Good written and verbal communication skills. Knowledge of MS Office. Good organizational and time management ability. Excellent interpersonal and leadership skills. Scientific or clinical research or medical writing experience desirable. Good understanding of regulatory requirements, good Pharmacovigilance practices and ICH GCP guidelines.

Primary responsibilities 1.Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects 2.Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3.Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1.Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2.Review of clinical and non-clinical overviews and summaries of CTD 3.Review of medical rationale for CT waiver applications 4.New products evaluation for development 5.Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6.Mentoring/ training team members to gain required skills to enable on-time deliverables.

Role Regional Managing Partner - Deputy Vice President, Kotak Agency - Field Sales (L7) Experience 6-12yrs. Job Role Recruitment Parameters -Increasing Distribution through Coding of new Partners & increasing LA base -Pragati Promotion -SAP / CAP Creation -Partner Promotion -Handhold & Coach Distribution for Recruitment -Minimum Distribution Criteria of 8:80 Business Parameters -Meet the budgeted business numbers -Maintain minimum Persistency of 85% -Coach & Train Agency to work Independently & Digitally -Meet the CLA numbers -Initiatives to improve Partner Income -Periodic meeting of Partners & Las -Support Agency with all relevant report & MIS Primary Responsibilities External Relations Internal Relations Educational qualifications preferred Category Bachelor's Degree

Job Title: Associate Managing Editor Department: Editorial Reports To: Managing Editor (or designated personnel) Job Purpose The Associate Managing Editor will report directly to the Managing Editor or any assigned authority. This role involves end-to-end management of academic journals, ensuring efficient onboarding, development, and growthparticularly in abstracting, indexing, and overall visibility. The incumbent will collaborate regularly with teams across SAGE India, UK, and US offices to resolve issues raised by editors, reviewers, or authors. A strong emphasis will be placed on maintaining excellent communication, building relationships with key stakeholders, and achieving performance metrics. Key Responsibilities Journal Management & Development Independently oversee tasks across the SAGE India journals portfolio. Ensure smooth transition of journals from acquisition to active editorial management. Collaborate with journal editors to identify needs related to workflow, timelines, indexing, promotion, and other editorial requirements. Closely monitor the publishing pipeline and assist editors in resolving delays or bottlenecks. Stakeholder Communication & Relationship Building Serve as the primary liaison for editors, reviewers, authors, and internal teams. Maintain a high level of professional communication and strong working relationships with all journal stakeholders. Address and resolve journal-related issues at any stage in the publishing process. Abstracting, Indexing & Journal Performance Drive improvements in journal visibility through indexing, abstracting, and impact factor initiatives. Educate and guide editors on best practices related to A&I and strategies to improve journal performance. Prepare and present publisher performance reports to internal and external stakeholders. Marketing & Promotion Work with the marketing team to plan and execute journal-specific promotions (e.g., Call for Papers, special issue promotion, impact factor campaigns). Assist in the development and review of promotional materials for conferences and events. Contract Management & Reporting Draft, review, and negotiate journal contracts, renewals, and addendums in coordination with legal or commercial teams. Maintain detailed journal-specific performance reports and documentation. Monitor and report on KPIs for both individual and journal performance. Strategic Initiatives Stay informed of trends and emerging practices in academic publishing. Contribute to department goals through proactive initiative and strategic thinking. Escalate complex or unresolved issues to the reporting manager when necessary. Skills, Qualifications & Experience Postgraduate degree in life sciences, medical sciences, or a related field. 3–5 years of relevant experience in journal publishing, particularly in an editorial or management capacity. Sound understanding of peer review systems, editorial workflows, and journal development. Familiarity with publishing contracts and journal performance metrics (e.g., Impact Factor, indexing databases). Proficient in Microsoft Excel, PowerPoint, SharePoint, Teams, and Outlook. Strong verbal and written communication skills. Experience with manuscript submission and peer review systems (e.g., ScholarOne, Editorial Manager) is a plus.

SUMMARY Job Title: SAR & SAR-like Patient Safety Physician Reporting To: Patient Safety Physician SAR & SAR-like Coordinator Minimum Educational Qualifications and Experience Required Skills 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 Operational Responsibilities Compile PBRERs with a focus on medical aspects and safety sections of products, and analyze safety trends, including source data analysis based on queries Assist in identifying, analyzing, and drawing conclusions from safety data for cumulative trends Collaborate with Therapeutic Head to identify signals and address product safety concerns Engage with Therapeutic Area colleagues for enhanced understanding and development Measurable Goals Ensure 100% compliance with timely completion of all client and Cognizant required trainings Achieve 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 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

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: Completes programming trial activities of low complexity and/or criticality, with high quality and timeliness of deliverables. Designs and develops programs in support of clinical analysis and reporting activities. May support submission activities including but not limited to creation, verification, and delivery of CDISC compliant and/or non-standard data packages. Performs activities in accordance with departmental processes and procedures. Performs appropriate quality control and verification in support of clinical analyses and reporting activities. Performs review and provides feedback on project requirements and documentation. Collaborates effectively with team and cross-functional members. 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. Clinical Programmer: Reviews specifications for mapping internal Data Review Model (DRM) for fit-for-purpose reporting consumption and ensures verification of DRM. Supports data cleaning by programming edit checks and data review listings and data reporting by creating data visualizations and listings for data management, medical monitoring, and central monitoring. Principal Relationships: This role reports into a people manager position within the Delivery unit and is accountable to the Portfolio and Study Leads for assigned activities and responsibilities. Functional contacts within IDAR include but are not limited to: Leaders and leads in Data Management and Central Monitoring, Programming Leads, Clinical Data Standards, Regulatory Medical Writing Leads, and system support organizations. Functional Contacts within J&J Innovative Medicine (as collaborator or peer) include but are not limited to: Statistics, Clinical, Global Medical Safety, Project Management, Regulatory, Strategic Partnerships, Human Resources. External contacts include but are not limited to external partners, CRO management and vendor liaisons, industry peers and working groups. Education and Experience Requirements: Bachelor s degree or higher and/or equivalent in computer science, mathematics, data science/data engineering/analytics, public health, or other relevant scientific field (or equivalent theoretical/technical depth). Experience and Skills Required: Basic knowledge of data structures and relevant programming languages for data manipulation, and statistical reporting which may include SAS, R, Python etc. Knowledge of SAS is preferred for Clinical Programming role. Basic knowledge of processes, methods, and concepts relevant to programming. Experience working in a team environment preferred. Demonstrated written and verbal communication skills.

Role & responsibilities Primary responsibilities 1. Medical monitoring of the in-house clinical trials and overseeing of CRO medical monitoring of outsourced projects. 2. Development and review clinical documents including protocol, investigator's brochure, case record form, product rationale, prescribing information, drug interactions etc 3. Organization of Subject Expert Committee meeting materials and attending SEC meetings for clinical trials and marketing approvals Secondary responsibilities 1. Medical Review of ICSRs, Aggregate reports, Signal reports and Risk Management plans 2. Review of clinical and non-clinical overviews and summaries of CTD 3. Review of medical rationale for CT waiver applications 4. New products evaluation for development 5. Develop, review and approve marketing requests of product evaluations, comparative safety and efficacy training material 6. Mentoring/ training team members to gain required skills to enable on-time deliverables. Required Educational Qualification: MBBS and/or MD (Pharmacology) Work Exp.: MBBS with 10-12 years of experience [OR] MD (Pharmacology) 8-10 years of experience Mandatory Skills Required: Clinical Trails, Protocol Writing, Medical Writing, Investigatioons

Roles & Responsibilities Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation Assist the Team Lead/Manager in the development of schedules to ensure timely delivery Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables Train and mentor junior members of the team on technical/process related aspects Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities Perform literature searches on various databases Screening, appraisal per pre-defined criteria, and summarization of articles Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use Summarize quantitative data from post-marketing surveillance Conduct editing, proofreading, document formatting, and other document completion/approval activities Education Bachelors Degree / Post Graduation in any relevant Life Sciences field. Masters Degree is preferred. Experience Publication experience in scientific journals preferable Minimum 3 years of experience in Medical Device Regulatory documentation Familiarity with the Life Sciences Industry, preferably Regulatory Services Hands on experience on CEP/ CER/ PMSR/PSUR process Experience in creating high quality deliverables for customers Experience in handling projects and engaging with multiple clients independently Experience of working on projects involving all devices classes from various Therapeutic Areas Technical/Functional Skills Knowledge of clinical evaluation and related documents and regulatory requirements Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature Proficiency with Microsoft Office (Word, Excel, and Outlook) Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage Effective reviewing skills for review of work done by trainees/junior writers Non-Technical Skills Strong verbal and written communications skills Ability to work as part of a team A constant zeal towards learning and skill development Potential to multitask and work within timelines Ability to understand and deliver on customer requirements Mentoring skills to act as trainer/mentor for junior members of the team Personal Traits Positive Attitude Initiative and Commitment Detail Oriented Team player Focused and sincere Perseverance Competencies Basic English grammar, punctuation, and sentence construction Logical comprehension Knowledge of medical terminology Excellent Communication (Writing and Verbal) Quality focused mindset Good time management Good stakeholder management.

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER’s that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 4-5 years of CER writing experience is essential. A minimum of 4-5 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area. Preferred EducationMasters’ degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience Preferred Experience: 1. The expected experience is 7 – 8 years with minimum 4-5 years of CER writing and reviewing experience as per EU MDR (European Union Medical Device Regulation (EU) 2017/745). Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1. 2. Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology and radiation oncology 3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER’s that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 3 – 4 years of CER writing experience is essential. A minimum of 3 – 4 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area. Preferred EducationMasters’ degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience Preferred Experience: 1. The expected experience is 7 – 8 years with minimum 3 – 4 years of CER writing and reviewing experience as per EU MDR (European Union Medical Device Regulation (EU) 2017/745). Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1. 2. Knowledge in the therapeutic area – specifically in the field of diagnostic radiology, interventional radiology and radiation oncology 3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.

Works with a team of Medical regulatory writers with different levels of expertise, Develops medical expertise within Medical regulatory writing (on contents, methods, and processes). Ensures compliance with regulatory requirements from various regions (FDA, EU others) for activities supported. Coordinates and supports medical activities related to the maintenance of the marketing authorizations of Established and Generic products, in different therapeutic areas. Works in close collaboration with Global Medical Leads, Global Regulatory Affairs, Global Pharmacovigilance, and vendors Essential Job duties and responsibilities: Responsible to provide a medical assessment with relevant and updated clinical evidence and monitoring the execution of strategic documents such as PBRERs, ACOs, DSURs, Clinical Overviews, Benefit-Risk assessments, Expert statements for MDD, Responses to Health Authority Queries, Ad-hoc literature analyses, and labeling documents for the corresponding therapeutic area or products or any other activities which are the core activities of GMLs. Drafting the extended synopsis of studies in collaboration with RWE experts. He/she will be responsible for overseeing the execution of such plans by the respective operational units in compliance with SOP, GCP, and other regulations. Writing of Key medical/clinical parts of Common Technical Documents (CTD) or Briefing packages (BP). Reviewing and approving compassionate use of individual medical requests for use of Sanofi medicinal products for serious or life-threatening diseases for treatment outside of clinical trials. Secure delivery of high-quality medical documents on time and in compliance with internal and external standards. Collaborates effectively with stakeholders: global medical leads/ medical product leads, global regulatory affairs, medical regulatory writing global or local teams, pharmacovigilance teams, managed access program teams. People: Maintain effective relationships with the end stakeholders (Medical, regulatory, pharmacovigilance community) within the allocated Global business unit and product with an end objective to develop medical regulatory content as per requirement, 2) Interact effectively with stakeholders in medical and pharmacovigilance departments 3) Constantly assist the medical regulatory writing team in developing knowledge and sharing expertise Performance: Secure deliverables (PBRER, ACO, SO, CSR, ID Cards, Investigator brochure, clinical evaluation report, briefing packages, medical section of CTA, CTD, SBRAs, MDD, HAQs or any other activities which are core activities for GMLs) are supported as per agreed timelines and quality Process: Provide medical strategic insights & evaluation related to Company's portfolio. Contribute to the management of the marketing authorization dossiers of the current related portfolio. Act as an expert in the field of medical regulatory writing and maintain the regulatory requirement for countries, and teams supported. Assist the assigned medical team in conducting comprehensive medical regulatory writing-needs analysis Implement relevant elements of the medical regulatory plan and associated activities for the year identified for the region Work with selected vendors when required within the region to deliver the required deliverables as per the defined process Assist the head of scientific communications in designing an overall plan of action based on end-customers feedback & improving course content and delivery. Stakeholders : Work closely with medical teams in regions/areas to identify medical writing needs and assist in developing assigned deliverables Liaise with the Medical department to ensure relevant & customized are delivered per expectation About you Experience : 5 years of experience supporting international pharmaceutical companies: medical affairs, clinical development, pharmacovigilance with experience in at least one of the therapeutic areas- cardiovascular, metabolism, diabetes and lipid, CNS, oncology, anti-infectives, internal medicine Soft skills : Stakeholder management; communication skills; and ability to work independently and within a team environment Technical skills : As applicable (Including but not limited to Medical operational excellence, time, and risk management skills, Excellent technical (medical) editing and writing skills) Education : Medical degree MBBS; MD Languages : Excellent knowledge of the English language (spoken and written)

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry

-Medical content creation in various therapy areas -Partnering with pharma PMT for conceptualising strategies -Creation of Brand promotional plan -Ideation of a campaign -Coordination with different dept. like graphic, IT etc -Knowledge of MS Office

Role & responsibilities Policy Development Facilitation: Draft, refine, and finalize medical policy documents. Collaborate with scientific literature researchers to incorporate comprehensive scientific evidence into policy drafts. Facilitate working sessions to refine and clarify policy drafts. Provide feedback and guidance to ensure alignment with organizational goals and standards. Medical Policy Updates and Maintenance: Ensure medical policy definitions are current and accurately reflect the latest medical guidelines. Regularly review and update medical policies to incorporate the latest scientific evidence and clinical best practices. Handle internal requests, scheduled reviews, and updates. Ensure policies are compliant with CMS policies such as NCDs and LCDs. Stakeholder Engagement and Communication: Foster strong relationships with key internal stakeholders, including policy writers, medical directors, and clinical leadership. Communicate policy changes and updates effectively to all relevant internal parties. Quality Assurance and Review: Conduct quality checks on policy documents before final approval and publication. Ensure consistency and accuracy in all policy documents. Implement a robust review process involving internal and external experts to validate policy content. Training and Development: Develop and deliver training sessions for policy writers on best practices and organizational standards. Provide ongoing support and mentorship to policy writers to enhance their skills and knowledge. Documentation and Process Management: Maintain comprehensive documentation of policy development processes and procedures. Develop and manage a repository for policy documents and related resources. Ensure all documentation is up-to-date and accessible to relevant stakeholders. Post approved policies in Confluence. Performance Monitoring and Reporting: Track and report on the progress of policy development projects. Provide regular updates to senior management on policy status, challenges, and achievements. Utilize data and metrics to assess the effectiveness of policies and identify areas for improvement. Your background & requirements: Required Experience: Preferred: Bachelors in nursing or advanced degree such as a Master of Science in Nursing, Master of Physician Assistant Studies, or Masters degree in Public Health, Health Science, Healthcare Administration, etc. 3-5 years of experience in medical writing, policy development, or scientific literature research and vetting. Familiarity with CMS policies such as NCDs and LCDs. Strong organizational and project management skills. Excellent communication skills, both written and verbal. Ability to manage multiple projects with competing priorities. Detail-oriented and enjoy managing simultaneous projects with multiple stakeholders. Ability to work well both as part of a team and independently. Ability to work independently in a remote work environment with minimal supervision. Proficient in using collaboration tools such as Confluence and project management software. Utilization review experience is a plus Preferred candidate profile - Life science graduate experienced for minimum of 3 yrs on NCD, CMS, LCD are mostly preferred.

Job Title: Medical Communication Specialist Career Level: D Introduction to role: Are you ready to apply your scientific expertise to build compelling medical content and communication? Join our team and support the delivery of life-changing medicines for patients by enabling the rest of the business to run optimally. Were on a journey of growth and evolution, finding innovative ways to translate value for the business and our patients. Accountabilities: Apply scientific knowledge and insights relevant to therapeutic areas, healthcare systems, products, disease state management, emerging therapies, and the competitive landscape, integrated with knowledge of the regulatory environment, to create compelling medical content and communication. Work together with Medical Information and Communications (MI&C) staff and key collaborators to implement scientific content strategy and build and share scientific content to fulfill customer needs. Support HCPs through delivery of high-quality, timely, customer-focused medical information. Contribute to MI&C processes to drive operational excellence, efficiency, and digital innovation. Scientific Content: Develop, review and maintain scientific communication materials (scientific narratives and foundations [platform], digital assets, Field Medical materials, and other medical materials) in collaboration with MI&C team and Medical Affairs. Translate published literature and emerging science into digestible formats for healthcare professionals (HCPs) and key internal collaborators. Perform literature searches to support content strategy. Advanced inquiries that are raised to Global MI&C team from local markets. Essential Skills/Experience: Advanced scientific degree (PharmD preferred, MD, PhD, or equivalent) Minimum of 3-5 years of experience in scientific communications or related roles within the pharmaceutical, biotechnology, or healthcare industry Skills/Capabilities: Clinical and healthcare systems expertise Scientific literature evaluation and analysis Excellent written and verbal communication skills with the ability to distill complex scientific information into clear and compelling messages for diverse audiences Scientific/medical writing, communication, and content creation (e.g., slide decks) Strong verbal and written communication skills Strategic problem solver with strong discernment, project management, and organizational skills Proficiency in applying technology/platforms Experience developing digital content and/or digital content strategy highly desired Experience in mentoring and coaching team members (for Manager position) Ability to apply local regulatory, legal, and compliance requirements to Medical Affairs activities and drug information deliver

We are looking to add an experienced Clinical Writer to our team. The person in this position must be able to independently contribute to the development of initial and update(s) of CER s that support the applicable regulatory submission requirements for the medical device products. An experienced Clinical Analyst professional has relevant medical/life-science qualification and knowledge/direct clinical experience in the use of the device or device type in a clinical setting. The expected experience is 7 - 8 years with a minimum of 3 - 4 years of CER writing experience is essential. A minimum of 3 - 4 years of medical writing/reviewing experience is needed. The experience is expected to be current or recent (preferably within the past two years), to provide confidence in their experience considering the rapid nature of updates/changes in the regulatory landscape, the device, its functionalities and the therapy area. Preferred Education: Masters degree in a life science or biomedical engineering discipline preferred, or equivalent regulatory/writing experience Preferred Experience: 1. The expected experience is 7 - 8 years with minimum 3 - 4 years of CER writing and reviewing experience as per EU MDR (European Union Medical Device Regulation (EU) 2017/745). Significant experience writing scientific, medical/clinical, and technical content. Also, a plus would be experience with writing CERs that conform to MEDDEV 2.7/1. 2. Knowledge in the therapeutic area - specifically in the field of diagnostic radiology, interventional radiology and radiation oncology 3. Familiarity with various country specific standards and regulations for medical devices to be able to assess and provide device appropriate clinical evaluation data for registrations.

*Greetings From You & I Consulting ! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. *Hurry Do Not Miss This Opportunity To Work For Global Giant MNC. We are hiring for the below locations under Medical Reviewer Role!! *Open Locations :- * Pune/ / Chennai / Mumbai *Mode Of Interview - Virtual *Mode Of Work :- Work From Office * CTC Upto - 10 To 24Lpa *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) or email your CV to puja@careersuni.com PFB Job Insights for Medical Reviewer Role!! Author a CCC for case reports that are Suspected Unexpected Serious Adverse reaction (SUSAR). Edit the Periodic Report Comment, if applicable, directly within the Periodic Report Comment field in the Patient Safety database. Perform the following actions within the Comments field of the GSP Review Workflow step in the Patient Safety database: Review and respond to any queries/comments from the Case Owner, which are recorded in the Comment field of the GSP Review Workflow step in the Patient Safety database. Detail any requests for changes to the case, including the narrative. Skills required:- Computer Literate (good knowledge of MS Office) Sound understanding of the Drug Safety and Regulatory process Good problem solving and decision-making skills Capability to lead by motivation and example Ability to prioritize schedule and organize Excellent interpersonal and communication skills * * *Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com ***Note we also have open positions for the below skills :- * * *Call Now our HR Specialist for more details:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com *Aggregate Reporting / Clinical Data Management / Clinical SAS / SQL Programmer / EDC Programmer / Medical Monitor / HEOR Health Economist Role / SAS + R / Statistical Programmer / Study Data Manager *Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please whatsapp your details to us in the below format: - Name- Mobile number - Mail - Qualification - Total work experience - Current Organization- Location - Last CTC Expected CTC:- *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist:- @ puja - 8250242229 (call or whts app) email your CV to puja@careersuni.com