279 Medical Writing Jobs - Page 5

Career Category Safety Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Periodic Report QC Reviewer What you will do Let s do this. Let s change the world. The primary responsibility of this role is to perform quality control reviews of of Amgen s Periodic Aggregate Safety Reports (PASR) e. g. Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR), Semi Annual Safety Update Report (SSUR), Periodic Adverse Drug Experience Report (PADER/PAER), Device PSUR, and country specific reports e. g. Korea PSUR, Brazil PSUR and Colombia Clinical Research Annual Safety Report Submission and Evaluation form. The QC Reviewer will ensure accuracy, consistency, and compliance with regulatory and company standards. This role supports the end-to-end writing and documentation process and ensures timelines are met. Key Responsibilities: Conduct thorough quality control reviews of PBRER/PSURs, DSURs, PADER/PAERs, and other aggregate safety reports to ensure content accuracy, data integrity, formatting consistency, and adherence to regulatory and internal requirements. Verify correct incorporation of safety data, narratives, tables, and appendices, ensuring alignment with source documents and databases. Collaborate with Periodic Report Specialists to address discrepancies and ensure timely resolution of quality issues. Maintain up-to-date knowledge of global regulatory requirements and industry standard methodologies for periodic safety reporting. Contribute to the development and refinement of QC checklists, templates, and SOPs to ensure consistent review practices. Track QC metrics and support continuous improvement initiatives related to safety report quality and delivery. Responsible for performing QC reviews of periodic safety reports to ensure compliance with the style guide, templates, and contributor inputs. Responsible for verifying content accuracy, data integrity, and consistency across all report components. Responsible for collaborating with Periodic Report Specialist to resolve QC findings and ensure timely delivery of high-quality reports. Inspection Readiness: Support inspection readiness efforts by ensuring all QC activities are well-documented, traceable, and compliant with applicable regulatory requirements. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 1 to 3 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Bachelor s degree and 3 to 5 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience OR Diploma and 7 to 9 years of pharmaceutical, biotech or regulatory authority experience in a research and development setting experience Strong attention to detail with the ability to identify inconsistencies and errors in complex regulatory documents. Proven ability to operate effectively in a collaborative environment requiring coordination, communication, and analytical judgment. Solid understanding of pharmacovigilance principles and global regulatory requirements related to periodic aggregate reporting (e. g. , PBRERs, DSURs, PADERs). Proficiency in scientific and technical writing/editing, with an emphasis on quality control and adherence to style guides and templates. Excellent written and verbal communication skills in English, with strong organizational and time management abilities. Demonstrated ability to manage competing priorities and strict deadlines while maintaining high-quality standards. Familiarity with the structure and content of safety reports and the ability to interpret and validate data inputs from multiple contributors. Proficient in Microsoft Office tools (Word, Excel, PowerPoint), Adobe Acrobat, and document management systems (e. g. , Veeva Vault, SharePoint). Working knowledge of AI tools and prompt use is a plus, especially for enhancing QC efficiency. Team-oriented approach with the ability to work cross-functionally to support compliance and inspection readiness efforts. Contribution: Ensures Amgen remains in compliance and becomes best in class with regard to periodic aggregate report processes Implements and maintains document standards Responsible for successful tracking of metrics, timelines, and performance indicators for PASR objectives. Preferred Qualifications: Health Care Professional with minimum 2 - 3 years of relevant work experience Including 1 to 2 years of experience in periodic aggregate safety report writing OR Bachelor s / Master s degree in Health/Life Sciences with minimum 2 - 3 years of Overall 2 + years of authoring/editing experience in medical writing domain across different therapeutic areas in safety documents including Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report (PBRER)/Periodic Safety Update Report (PSUR). Experience in preparation of safety documents necessary for national and international regulatory submissions to the US, European Union and other regulatory agencies. Knowledge of Pharmacovigilance regulations for Periodic Aggregate Safety Reports. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. .

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying medical or technical information into clear, structured documents and engaging content. Good Knowledge of Medical terminology. Required Candidate profile Preparation of protocol for Clinical trials Preparation writing CSR (Clinical Study Report) BDS and MBBS With medical writing for clinical trials Knowledge are Applicable

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Should have knowledge in clinical research studies Monitoring of Clinical studies conducted at various CROs located globally as per ICH/GCP, applicable regulatory requirements, protocols and SOPs. Perform Site visits (i.e. Site Selection Visit) Required Candidate profile Strong understanding of clinical trial processes and regulatory requirements. Excellent clinical assessment skills and a commitment to patient safety and ethical research practices.

Role & responsibilities: 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH, ,National registries (DIMDI)) CTT Data base experience ( Disclose, Prime, PRS, EudraCT) Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process

Role & responsibilities: 1. Authoring and Quality Assurance of Project Activities Executes project specific activities with high quality and in defined timelines according to standard processes and operating procedures Marking /QC/Review and/or editing of pertinent documents such as: Clinical study documents or any other documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc. for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH) Protocol and results summaries to support clinical trial disclosure commitments Systematically perform quality control checks of documents prepared by colleagues against pre-specified checklist generated in the project or SOP Perform detailed analyses on a planned and ad hoc basis, relating to processes and their outputs Ensure to abide with Client process Preferred candidate profile: Experience in redactions/anonymization of clinical documents as part of preparation for different regulations. Well versed with Health Canada /EMA policy.

Hi, We are hiring for Leading ITES Company for Medical Writer Profile. Overview A medical writer is responsible for developing clear, accurate, and well-structured medical and scientific documents tailored to specific audiences, such as healthcare professionals, regulatory authorities, or the general public. Their role involves translating complex clinical and scientific data into understandable content for various purposes, including regulatory submissions, clinical trial documentation, journal articles, educational materials, and healthcare communications. Medical writers collaborate closely with researchers, regulatory teams, and subject matter experts to ensure that the information is scientifically sound, compliant with industry guidelines, and aligned with the target audiences needs. Attention to detail, strong writing skills, and a solid understanding of medical terminology and research practices are essential in this role. Key Skills: a) Minimum 1 Year experience in - eCTD / NEES / Docubridge b) Should have Experience in making Clinical Study Report and Clinical Summary of Safety c) Any Life Science Graduate To Apply, WhatsApp 'Hi' @ 9151555419 Follow the Steps Below: >Click on Start option to Apply and fill the details >Select the location as Other ( to get multiple location option ) a) To Apply for above Job Role ( Mumbai ) Type : Job Code # 56 b) To Apply for above Job Role ( Pune ) Type : Job Code # 57 Role & Responsibilities: Prepare and review clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, and Post Approval Documents across the Therapeutic Areas. Quality check of the clinical documents that are part of regulatory submission including but not limited to Protocol, Clinical Study Pharmacology Report, Clinical Study Report, Narratives, Clinical Summary of Safety, Clinical Summary of Efficacy and Common Technical Document Modules. Initiate start up meetings with the Study Teams related to the creation and development of the clinical document for regulatory submission, if required. To work in coordination with all the members in the study team- internal and external for the development of clinical documents. Share project timelines amongst the study team for the development of document. Prepare Clinical Documents according to the Standard Operating Procedures, Document Standards and Guidance document. Review statistical analysis plans and table/figure/listing, when required. Ensure uniformity and consistency in the scientific content of the regulatory documents Preparation of documents in the scope and other Medical Writing documents that may be required for domestic and international regulatory submissions to the US, European, and other regulatory agencies. Prepare Medical Writing documents within established timelines that are of high quality for scientific content, organization, clarity, accuracy, format, and consistency, with adherence to regulatory guidelines and applicable standards, styles, guidelines, and processes. Perform peer review and quality control review of the documents within established timelines with adherence to applicable guidelines, and processes, using appropriate checklists. Take an active role on assigned projects with respect to planning of content, format, and timing of documents, report scheduling/tracking, etc. Provide support to the assigned clinical development or project team to ensure that project needs, and department standards are met, while completing reports within established schedules/timelines. Plan and organize project and non-project meetings, as and when required

We are seeking a qualified and experienced Professor of Respiratory Medicine to join our esteemed medical faculty. The ideal candidate will have significant clinical experience, a passion for teaching, and a commitment to advancing research in the field of respiratory health. Responsibilities Teach and mentor undergraduate and postgraduate students in respiratory medicine. Conduct research in the field of respiratory medicine and publish findings in reputable journals. Provide clinical supervision and training to residents and fellows in respiratory medicine. Participate in departmental meetings and contribute to curriculum development. Engage in community outreach programs to promote respiratory health awareness. Skills and Qualifications MD or DNB in Respiratory Medicine from a recognized institution. 8-12 years of clinical experience in respiratory medicine. Strong knowledge of current trends and advancements in respiratory medicine. Excellent communication and interpersonal skills for effective teaching and patient interaction. Proven track record of research publications in peer-reviewed journals. Ability to work collaboratively within a multidisciplinary team.

We are seeking a dedicated and knowledgeable Assistant Professor of Pharmacology to join our esteemed institution. The ideal candidate will have a strong background in pharmacological sciences and a passion for teaching and research. This position offers an excellent opportunity to contribute to the academic and professional development of students in the field of pharmacology. Responsibilities Teach pharmacology courses to undergraduate and postgraduate students. Conduct research in the field of pharmacology and publish findings in peer-reviewed journals. Supervise and mentor students in their research projects and clinical rotations. Participate in departmental meetings and contribute to curriculum development. Engage in community outreach and educational programs related to pharmacology. Skills and Qualifications MD or DNB in Pharmacology or related field from a recognized institution. Strong understanding of pharmacological principles and their application in clinical settings. Excellent communication and presentation skills. Ability to work collaboratively in a team-oriented environment. Research experience in pharmacology with a track record of publications is preferred. Familiarity with educational technology and online teaching platforms.

Authoring/editing of clinical documents Review of the clinical/safety documents Assist senior writers Keep abreast of project status Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards Required Candidate profile 3+ years’ of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including protocol, informed consent document, clinical study report, etc.

Skill required: Pharmacovigilance Services - Pharmacovigilance & Drug Safety Surveillance Designation: Pharmacovigilance Services Associate Qualifications: Bachelor of Pharmacy/Bachelor in Physiotherapy/BSc. Nursing Years of Experience: 1 to 3 years 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 world's leading biopharma companies bring their vision to life - enabling them to improve outcomes by converging around the patient, connecting scientific expertise with unique insights into the patient experience.Management of the Affiliate Mailbox, reconciliation of reports per process, and performance of all written follow-up attempts to include both Serious and Non-serious cases.Create and manage case identification, data entry, MedDRA coding, case processing, submission, and follow-ups for ICSRs in the safety database as per client guidelines and applicable global regulatory requirements. What are we looking for? Ability to work well in a team Adaptable and flexible Agility for quick learning 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 Qualifications Bachelor of Pharmacy,Bachelor in Physiotherapy,BSc. Nursing

Job Summary Join our dynamic team as a Pharmacovigilance Specialist where you will leverage Generative AI to enhance drug safety processes. This hybrid role offers the opportunity to work on cutting-edge projects in Research and Development and PV Case Processing ensuring the well-being of patients worldwide. With a focus on innovation you will contribute to the companys mission of improving healthcare outcomes. Responsibilities Utilize Generative AI tools to analyze and interpret pharmacovigilance data ensuring accurate and timely reporting. Collaborate with cross-functional teams to develop strategies for effective PV case processing and management. Conduct thorough research and development activities to improve drug safety protocols and procedures. Implement innovative solutions to streamline pharmacovigilance processes and enhance efficiency. Monitor and evaluate the impact of AI-driven methodologies on drug safety outcomes. Provide insights and recommendations based on data analysis to support decision-making in pharmacovigilance. Ensure compliance with regulatory requirements and industry standards in all pharmacovigilance activities. Participate in the development and maintenance of pharmacovigilance databases and systems. Support the preparation and submission of safety reports to regulatory authorities. Assist in the identification and assessment of potential safety signals and trends. Contribute to the continuous improvement of pharmacovigilance practices through research and innovation. Engage in knowledge sharing and training sessions to enhance team capabilities in AI and pharmacovigilance. Foster a collaborative environment that encourages creativity and problem-solving in drug safety initiatives. Qualifications Demonstrate proficiency in Generative AI and its application in pharmacovigilance processes. Possess a strong understanding of research and development methodologies in drug safety. Exhibit experience in PV case processing and management. Show familiarity with regulatory requirements and industry standards in pharmacovigilance. Display excellent analytical and problem-solving skills. Have the ability to work effectively in a hybrid work model. Demonstrate strong communication and collaboration skills. Certifications Required Certification in Generative AI applications in healthcare or pharmacovigilance.

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage Should have good communication Skills

Key Responsibilities - Research and write engaging, accurate, and well-structured scientific articles, news updates,and career-related content Generate Content ideas and pitch them in editorial form. Assist in editing and proofreading articles, blogs, and educational materials Stay updated with the latest scientific trends, publications, and breakthroughs Maintain a consistent tone and scientific accuracy in all content Digital skills and Tools utilisation Social Media Engagement Email Marketing and Web Presence Data Mining And Analysis Educational Requirements - 1.Completed B.Sc / M.Sc / M.Tech / Ph.D. in Biotechnology, Microbiology, Biochemistry, or related fields. 2. Excellent written and verbal communication skills in English. 3. Strong understanding of scientific literature and research methodology. 4. Ability to simplify and articulate complex scientific ideas. 5. Detail-oriented with good time management skills. 6. Knowledge of digital writing and content creation. Benefits - Hands-on experience in scientific communication and content development Exposure to the latest developments in the biosciences industry Opportunity to work with an experienced editorial and research team Certificate of completion at the end of Internship. Potential opportunity for full-time employment at Biotecnika based on your performance.

Job Title: Medical Content Writer Location: Hyderabad Experience: 0.6 months to 6 years Employment Type: Full-time Job Description We are seeking a highly motivated and detail-oriented Medical Content Writer to join our team. The ideal candidate will have a strong background in medical sciences and a passion for creating high-quality, accurate, and engaging medical content for various platforms. Key Responsibilities: Content Creation: Develop, write, and edit medical content for e-learning modules, articles, blogs, presentations, and other educational materials. Research: Conduct thorough research on medical topics to ensure content accuracy and relevance. Collaboration: Work closely with subject matter experts, instructional designers, and the technology team to create comprehensive and interactive learning experiences. Technology Integration: Utilize and adapt to new technologies, including AI-driven tools, for content development and enhancement. Quality Assurance: Review and update existing content to maintain accuracy, clarity, and compliance with medical standards. Continuous Learning: Stay updated with the latest advancements in medical science and educational technology. Qualifications: Educational: MBBS (Mandatory). Experience: 0.6 months to 6 years of experience in medical content writing or related fields. Skills: Excellent writing and communication skills in English; strong research aptitude; familiarity with digital tools and platforms. Attitude: Keen interest in writing and learning; willingness to work with AI technologies and collaborate with cross-functional teams. Location: Ready to work onsite at Hyderabad. Desirable: Prior experience in e-learning or medical education content development. Knowledge of AI applications in medical content creation is a plus. Ability to work in a fast-paced environment and manage multiple projects. Role & responsibilities

Typing the details of medicines in a proper manner. Explain the position details and other prerequisites to the patient before carrying out the procedures. Understand the patient diagnostics background and carry out the procedure accordingly Maintain and check the equipments and accessories to be used. Upkeep of all technical equipments including imaging equipments. Coordinate with doctors and nurse in finalizing the list of patients undergoing the various procedures. Arrange the items for department from stores. Responsible for maintenance of quality of films . Maintain the equipment log book and inform the bio-medical engineer in case of any failures in the equipment. Interested candidates can contact at 8447435198

Medical Writing Associate II Job Details | Teva Pharmaceuticals Find a Career With Purpose at Teva Search by Postal Code Area of Interest Select how often (in days) to receive an alert: Select how often (in days) to receive an alert:

Job Purpose To grow and strengthen Sages portfolio of medical and health sciences journals in alignment with the company’s strategic objectives. The primary focus is on acquiring and commissioning high-quality, high-impact journals through active market engagement and relationship-building with academic institutions, research societies, and relevant organizations. The role requires a strong commitment to editorial excellence, global relevance, marketability, and rigorous peer review standards. Key Responsibilities Strategic Implementation & Business Development Drive the expansion of Sage’s medical journals portfolio in line with strategic growth plans. Develop and execute a robust commissioning strategy for Sage India with measurable goals. Identify, evaluate, and acquire journals that align with Sage’s editorial and commercial priorities, including both core and Spectrum services portfolios. Maintain and update stakeholder records, tracking engagement and follow-up actions. Market Engagement & Brand Building Represent Sage at national and international medical conferences, workshops, and institutional meetings to raise the company’s profile and generate acquisition leads. Build and maintain relationships with editors, academic societies, research institutions, and think tanks. Monitor and report on market trends, competitor activity, and emerging opportunities to inform strategy. Develop and deliver presentations and workshops to promote Sage’s journals and author services. Editorial & Commercial Evaluation Prepare and present Journal Summaries for internal evaluation, ensuring alignment with Sage’s global publishing policies. Conduct comprehensive editorial and market assessments, including analysis of the competitive landscape, society/editor credentials, and commercial viability. Prepare detailed profit and loss (P&L) projections and determine appropriate pricing strategies. Contracting & Internal Coordination Manage the end-to-end contracting process, from proposal development to final agreement execution. Liaise with internal departments including Sales, Production, Peer Review, Marketing, Customer Service, and Finance to facilitate successful journal onboarding. Ensure timely issuance, review, and execution of all contracts and related documentation. Maintain complete records of all journal acquisition paperwork and ensure accurate handover to editorial and production teams. Skills & Competencies Strong relationship-building skills with academic and institutional stakeholders. Proven track record in medical publishing or commissioning, with a clear understanding of the academic market. Excellent communication, negotiation, and presentation abilities. Sound commercial and financial acumen; ability to assess journal performance and viability. Analytical mindset with the ability to interpret market and performance data. Strong project and time management skills; ability to manage multiple priorities. Proficient in Microsoft Office (Word, Excel, Outlook). Comfortable working in a collaborative, multicultural, and fast-paced environment. Willingness to travel frequently for business development and stakeholder engagement. Qualifications & Experience Education: Master’s degree in medicine, dentistry, life sciences, or related fields. Alternatively, a strong graduate qualification with demonstrable relevant experience. Experience: Essential: Minimum 2 years of experience in medical journal publishing, commissioning, or a similar business development role. Experience in client engagement, lead generation, contract negotiation, and academic relationship management. Desirable: Familiarity with Sage’s journal programmes. Experience working in an international and cross-functional publishing environment. Key Behaviors Proactive and self-motivated Passionate about academic publishing and commissioning Detail-oriented and organized Persuasive and confident in negotiations Flexible and adaptable to change Accountable and results-driven Collaborative team player Willingness to travel as required

Responsibilities: * Prepare clinical study reports and protocols. * Ensure compliance with ICF and ICH-GCP guidelines. * Collaborate on clinical research projects. * Write medical communications for regulatory submissions. Provident fund

correct Job description: If you are interested, please call 9094200201 and email your resume to rajesh_r@jrkresearch.com. Location: Kundrathur, Chennai Role: Copy editor and content writer Proofread and correct scientific and marketing communication about JRK requires products and packaging materials like labels, cartons, etc., before printing Should give content to promote on social media. Able to handle social media posting the content, videos and the blogs and need to have a track on the posting and boosting the posts. Submit work to the concerned heads for input and approval Coordinate with designers to execute the ideas planned for designing promotional materials, gifts, communication and packaging materials. Need to coordinate the design of creatives for social media posts and product videos. Update website content as needed. Write clear marketing language to promote our products Should write blogs. Proofread and edited blog posts before publication Must require excellent written communication skills in English Ensure all round consistency (style, fonts, images) Should be able to train the marketing teams for products Should be able to prepare the PPTs for product communications Should be able to commute between the Head Office and Corporate Office Qualification: Biotechnology/B.Pharmacy/BSC /MSC Life Sciences.

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

The PV Scientist is primarily responsible for the conduct of benefit-risk assessment activities including: ad hoc data analysis in support of internal/external queries; preparation, review and submission of aggregate reports; signal detection; support of benefit-risk evaluation efforts; generation of risk management plans (RMPs), risk evaluation and mitigation strategies (REMS), identification and tracking of risk minimization measures; handling of responses to Regulatory Authority queries, scientific/medical input to other safety related documentation including Health Hazard Evaluations, clinical study protocols, final study reports, dossier documents, Medical Affairs activities, commercial/marketing information, as needed and providing support for product labelling activities. Other activities relevant to the medical assessment responsibilities can also include: Query management; coordination with internal and external stakeholders for assigned medical assessment activities, and quality review of deliverables. All of the above are conducted in accordance with regulatory requirements and internal DRL standards. Main Responsibilities: Signal management: Conduct signal management activities for assigned products, performing initial review of signal alerts, ensuring signal detection is conducted in a regular, timely manner in accordance with schedule. This may include interaction with the LifeSphere Signal Management System and/or review of outputs generated from the system. Aggregate Reports and RMPs: Contribute to the scheduling of aggregate reports, RMPs and other safety related documents to ensure all required reports are documented on the report calendar. Maintain and harmonize global trackers for all aggregate reports across the regions Preparation of aggregate reports including: PSUR, PBRER, PADER, Annual Reports, DSURs, ACOs. Conduct peer quality review of aggregate reports, and quality review of reports generated by the vendor and by internal resources. Ensure all aggregate reports are prepared, reviewed and submitted in line with regulatory requirements Prepare RMPs and contribute to REMS activities as required Contribute to the implementation and tracking of additional risk minimization measures in collaboration with PV physicians, local affiliates and third party partners Prepare Health Hazard Evaluations and other ad hoc safety reports as requested Conduct benefit-risk evaluations under the supervision of PV physicians Clinical & Regulatory Activities: Provide safety input to other cross-functional documents, including clinical study protocols, study CRF, statistical analysis plan (SAP), coding review reconciliation, final study reports, dossier documents and other documents required to support filing activities. Participation in product/project team meetings. Provide safety input, advice and support to commercial, marketing and Medical Affairs activities as required Labeling document review: under the supervision of PV physicians, provide medical input to reference safety information, Investigator Brochures, product labels and patient information leaflets to ensure the most up to date and accurate safety information is present in all labeling information Regulatory Authority query management: liaise with Regulatory Affairs to respond to PV –related Regulatory Authority queries; coordinate with various stakeholders when finalizing the response, ensure responses are tracked to closure Provide data for internal compliance meetings, monthly report and for inclusion in the PSMF as required Raise deviations to PV processes where identified Participate in development of CAPA and take ownership of CAPA completion where assigned Participate in regular, scheduled meetings with PV team/service provider/third parties as required Initiate or support the development and revision of PV Medical Assessment SOPs and work instructions. Also participate in the review of cross-functional SOPs which include reference to PV Medical Assessment Activities. Support PV training for new members of PV team and non-PV personnel, particularly product-specific, scientific and medical training Perform other ad hoc, PV related activities as requested by head medical assessment Relationship Management Working within PV team and cross-functionally Interactions with vendors/service providers for PV activities Process Improvement / Standardization Participate in process improvement initiatives, as applicable Participate in safety database/PV system upgrade activities such as defining user requirements and conducting user acceptance testing Desired Skills & Competencies Good working knowledge of PV regulations including FDA, EU & local requirements. Strong data analysis and report writing skills Excellent teamwork and interpersonal skills Excellent time management and organizational skills Good knowledge of computer applications and software, including MS Word, Excel, PowerPoint etc. Qualification M. Pharm (Pharmacology) or equivalent with 3 to 7 years of experience in pharmacovigilance with experience in writing and reviewing PV Medical Writing Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. The World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. 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

Medical Review Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual case safety reports (ICSRs) in support of safety surveillance for Amgen products To support global individual case safety reports regulatory reporting compliance To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) To implement the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports To act as a significant point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Support MSRT product lead if assigned Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support MSRT Product Lead activities for the list of expected terms in the auto label tool Support Quality Assurance of ICSR medical review (if applicable) Support training to vendor staff (if applicable) on ICSR medical review Mentor junior medical reviewers. Participate in Safety Assessment Team (SAT) (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review Perform other duties related to the position as necessary as defined in SOPs or as requested by his/her supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 3 years of related drug safety experience Knowledge of Amgen Medical review and case management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including the Amgen Safety database and medical coding Knowledge of safety data capture in clinical trials and in the post marketing environments Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 4 years relevant work What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Medical Review Senior Associate Scientist What you will do Let’s do this. Let’s change the world. In this vital role you will provide medical review of individual safety case reports (ICSR) in support of safety surveillance for Amgen products. Responsibilities: To support global individual case safety reports regulatory reporting compliance. To assure medical validity of ICSRs and provide input to the activities of Medical Safety Review Team (MSRT) Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. To act as a point of contact for Case Management on medical content of ICSRs Execute the medical review of ICSRs (narratives, coding, expectedness, causality and seriousness) to ensure quality reports. Produce medically accurate ICSRs reports Execute ICSR case escalation as appropriate Execute appropriate case follow up per SOPs Support medical coding conventions, and systematic process improvements for ICSR medical review Conduct reportability assessment for medical device associated events and /or product complaint associated events, and review for potential product problems. Support Quality Assurance of ICSR medical review (if applicable) Provide input on teams for interdepartmental and cross-functional initiatives including, process improvement, standards development, Standard Operating Procedures (SOP) creation, and metrics with regards to medical review (if applicable) Perform other duties related to the position as necessary as defined in SOPs or as requested by their supervisor Inspection Readiness: Undertake activities delegated by the QPPV as detailed in the PV System Master File and maintain a state of inspection readiness Be representative and point of contact for Health Authority Inspection and Internal Process Audits within the remit of role and responsibility What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: MD/DO or international equivalent AND 1 year of related drug safety experience Knowledge of Amgen Medical review and Case Management SOPs and regulatory requirements for pharmacovigilance Clinical knowledge of therapeutic area patient populations and drug class Proficiency in technical safety systems including Safety Database and medical coding Knowledge of safety data capture in Clinical Trials and Post Marketing setting Knowledge of clinical trials and drug development Knowledge of Amgen products and patient population (preferred) Preferred Qualifications: MD/DO or international equivalent AND 3 years of relevant work What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.