113 Scientific Writing Jobs - Page 3

The Associate Medical Expert in TCO (Translational Clinical Oncology), is the medical leader for assigned global, roll-over and long-term follow-up studies, and studies in the close-out phase. They may also provide medical support for assigned aspects of a global, active, TCO study, under the leadership of a Clinical Program Leader (CPL) and / or Medical Expert TCO (Translational Clinical Oncology) is a department under Biomedical Research division, and is responsible for designing and executing out early phase (first in human) clinical studies in patients with cancer. It acts as a bridge between drug discovery and late phase clinical development and strives to deliver transformative new medicines for oncology conditions. About the Role Major accountabilities: Provides medical support to Clinical Program Leader (CPL) and / or Medical Expert. Medical support may include, but is not limited to, contributing to clinical sections of protocols and/or amendments, Informed Consents, publications, regulatory documents such as Investigator Brochures, responses to Health Authority questions and conducting ongoing review of clinical trial data, with oversight of TCO deliverables. May act as the medical monitor to support overall program safety reporting (eg, Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety Team. Contributes to clinical/scientific elements of TCO - related submission documents, including preparation and review of project documentation for Health Authority submission, including briefing books, IBs, Annual Safety Reports, responses to Health Authority questions etc Contributes to the ongoing clinical trial data medical/scientific review across assigned TCO studies and coordinates data analysis and interpretation Supports conduct of dose escalation meetings, investigator teleconferences and site initiation visits etc Accountable for assigned close-out, roll-over and long-term follow-up studies, ensuring Clinical Study Report review, consistency and quality of clinical study reports (CSR) in collaboration with CSR medical writing team, and publication of studies across assigned TCO projects - either directly as lead author or by providing leadership to the medical writing team Maintains expert knowledge of ICH-GCP, external regulations and procedures, and supplements by training and practice of Novartis SOPs and internal policies. Advocate continuous improvement of quality Key performance indicators: Evidence of high-quality medical input to assigned studies to ensure execution according to timelines and ensuring adherence to international and local regulations. Evidence of quality medical and scientific review of clinical trial data Demonstrates excellent scientific writing skills to enable the development of high-quality documents including but not limited to clinical trial protocols, trial reporting (eg CSR), and regulatory documents (eg IB, DSUR). Contribution towards objectives set for the department. Feedback from external and internal stakeholders. Clearly demonstrates Novartis Values and Behaviors. Minimum Requirements: MD or equivalent medical degree required. Advanced knowledge and clinical training in a medical/scientific area (eg, internal medicine / pharmacology etc) with medical council certification required. Experience in hematology / oncology preferred. Work Experience: At least 2 years of pharmaceutical/biotech industry experience or at least 4 years of clinical practice experience in the hospital setting Knowledge of Good Clinical Practice (GCP). Strong operational project experience including excellent planning, prioritization, problem solving and organizational skills. Used to managing multiple priorities. Demonstrated operational excellence and scientific contribution to clinical or preclinical projects. Clear written and verbal expression of ideas, an active/proactive communicator. we'll-developed interpersonal skills, with a proven record of accomplishment of successfully interacting with, influencing and building strong positive relationships. Used to working independently and in a team, being flexible and adapting in a changing environment. Skills: Clinical Monitoring. Clinical Research. Clinical Trial Protocol. Clinical Trials. Decision Making Skills. Drug Development. Health Sciences. Lifesciences. Regulatory Compliance. Languages : English.

The Preclinical Safety (PCS) department within the Novartis Biomedical Research - Translational Medicine Unit provides non-clinical safety strategy of products in -discovery, -development and -market, globally, with state-of-the-art regulatory compliance. As a Principal Scientist-2, you will join our PCS team in India to discuss strategies and deliver non-clinical safety deliverables for the products you are globally responsible for. This role also involves development and review of nonclinical scientific submission components (eCTD module 2.4 and 2.6) and other lifecycle management regulatory documents for multiple projects. Key Responsibilities : Strategy and delivery of PCS deliverables for products under development and in-market. Independently provide PCS inputs in PSURs, DSURs, annual reports, registrations, renewals and label updates for the delegated products.Addresses regulatory queries on delegated products. Conducts literature searches and analyzes relevant non-clinical safety data and decide benefit-risk of new nonclinical information in collaboration with patient safety experts. Contribute to the objectives and deliverables of (Global Project Team) in cross-functional collaboration with other GPT representatives. Evaluates the toxicological profiles of impurities, degradants and assess the specification limits based on ICH guidelines. Provides to nonclinical scientific writing support fo regulatory submission documents such as, IB, IND/CTA, NDA/BLA/MAA and Health Authority briefing books. Organizes nonclinical scientific activities and timelines in collaboration with authors for planned submission to meet strategic objectives of nonclinical submission deliverables. Develop expertise in internal Document management system to facilitate timely completion of projects and meet compliance requirement. Act as a nonclinical scientific liaison to Submissions Documentation (SD) vendor supporting nonclinical submission document management. Ensure that all the activities and deliverables are compliant with Novartis animal welfare policies, in-house standard operating procedures, Novartis expert recommendations (where feasible) and all relevant international regulatory guidelines/regulations. Be a team player and support local implementation of Preclinical safety strategies and independently contribute to multidisciplinary project/program goals within the Preclinical safety team. Communication skill is critical to this role in forming strong working relationships with team members and across functional disciplines. Essential Requirements: PhD in life sciences with 6+ years experiences in drug discovery, drug development and/or life cycle management studies with an exceptional understanding of nonclinical submission writing In-depth knowledge of toxicology and preclinical safety assessment, understanding of drug metabolism and pharmacokinetics / pharmacodynamics, experience working in project teams, and knowledge of drug development and regulatory environment Understanding of GLP principles in nonclinical studies and submission writing. Proficient with full range of techniques used in job and core areas. Working knowledge of tools and processes used in drug design and development. Extensive library research skills and knowledge of problems-solving techniques; publication and presentation experience preferred. Excellent communicators, strong team players and have a high level of logistical/planning ability.Strong written and verbal capabilities in English preferred. Registration and certification with one of the International Toxicology registers. Desirable Requirement: Animal Models ,Communication Skills, Data Analysis. Ethics ,Laboratory, Problem Solving. Regulatory Compliance. Research. Risk Assessment. Toxicology

Review of promotional and medical communication materials (for various client products) and ensure the content in these materials is medically accurate, scientifically rigorous, truthful and balanced, relevant to product and therapy area, compliant to various pharma regulations and guidelines and is supported by authentic and up to date references. Develop and update content for various medical materials, perform literature search to identify appropriate references to support creation/update of scientific content, track and audit assets for various purposes. Develop and review content for various deliverables meeting quality requirements as per client satisfaction metrics, within assigned timelines and with guidance from the manager. The tasks will be carried out as per assigned processes, guidelines, and SOPs with help of tools and platforms specified by the client and the manager. Responsible to follow the best practices in the department regarding - processes, communication (internal & external), project management, documentation, and technical requirements like - language, grammar, stylization, content search, summarizing, data conflicts and referencing. Participate in assigned training programs and work on assignments as per requirement. Participate in client calls as per project requirements. Compliance to quality, confidentiality and security; Adhere and follow quality systems, processes and policies; Comply to training and specifications Key Requirements: EXPERIENCE: Minimum 2 to 5 years of experience EDUCATION: MD/MDS/PhD with Post Doc (or experience)/MBBS with experience . Location: Hyderabad, Banglore, Mumbai, Delhi/Ncr, Pune Interested Candidate Please Apply - India.hr@infinitysts.com

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

Design and deliver engaging physics courses, including lectures, labs, and seminars.Provide academic advising and career guidance to students.Support student organizations, outreach programs, and competitions related to physics.

Research of the content topic & writing SEO content for Homeopathy. Literature/reference searching. Familiar with medical terminology & concepts. Medical contents/articles for magazines & research publication. BHMS, BAMS, BDS qualified are preferred.

Being up to date with technical /scientific developments &relating them to various projects Client-oriented attitude with focus on creating strong long-term clients relationships To assure timely completion of assignments Problem identifier & solver Required Candidate profile Knowledge of any specialty area of medicine/ an overall understanding of medical field Strong flair & passion for writing Strong written &verbal communication/presentation skill Passion for networking

About The Role Role Purpose The purpose o central quality analyst role is to conduct quality audits and perform analytics in different areas as defined by central quality team, supporting the project teams in ensuring higher client satisfaction ? Do 1. Conduct process quality audits as per plan Conduct various process audits as per guidelines and SPO’s defined in QMS Prepare findings from the report and share it with the account/ project leadership on daily/ weekly/ monthly, as required Conduct weekly analysis to identify the error trends and for top 2 errors, conduct root cause analysis (RCA) Conduct calibration communication to communicate any changes from the client and conduct refresher trainings to bridge any skill gap due to these changes 2. Conduct analysis, report generation and process compliance in different areas like metrics office, CAG, Process Definition Ensure processes to be followed in Wipro in terms of all quality norms in the areas of project management and highlight potential risks Provide insights and process guidance to the projects as per the need Prepare timely dashboards, reports, insights and share with the central quality and delivery teams to ensure minimum client escalation From time to time highlight any critical escalations where the central quality team’s intervention is required in any BU project team Automate the report generations etc to ensure minimization of non-value added tasks, ensuring maximum utilization of existing platforms and their increased adoption ? Deliver No. Performance Parameter Measure 1. Quality Standards Timely generation of reports, dashboards, insights to the respective team Accuracy of the data Feedback from the project teams on the insights Quality of insights shared with the team ? ? Mandatory Skills: Med& Scientific Writing, Regulatory Ser. Experience5-8 Years. Reinvent your world. We are building a modern Wipro. We are an end-to-end digital transformation partner with the boldest ambitions. To realize them, we need people inspired by reinvention. Of yourself, your career, and your skills. We want to see the constant evolution of our business and our industry. It has always been in our DNA - as the world around us changes, so do we. Join a business powered by purpose and a place that empowers you to design your own reinvention. Come to Wipro. Realize your ambitions. Applications from people with disabilities are explicitly welcome.

IntelliMed Healthcare Solutions was established in 2019 by Dr. Anish Desai in Mumbai. In the current challenging healthcare scenario due to regulations, innovations, pricing pressures, and a highly informed patient, the idea was to provide healthcare companies with a scientific edge to gain competitive advantage. Within a short period, IntelliMed has witnessed steady growth, venturing into areas like strategic medical affairs for business growth, thereby infusing science into marketing. IntelliMed specializes in scientific, clinical & medical solutions from conceptualization/ideation to launch. IntelliMed enables meaningful engagement with external stakeholders - Physicians, Patients, Providers &Policy Makers/Payers - the 4 Ps. IntelliMed helps to achieve market access by leveraging the healthcare drivers - Awareness, Adoption, Affordability & Access - the 4 As. It can support the entire lifecycle management process by providing contract medical resources, to support 4Ds, Data generation (Clinical & Economic) Product Differentiation and Dissemination of information along with Education and training with Diligence. IntelliMed has been a scientific partner for digital healthcare. It collaborates with you to build market access for Pharmaceuticals, Medical Devices &Nutraceuticals. It specializes in Contract/Outsourced Medical Affairs Services.. https://www.intellimed.org/ Medical Affairs Executive in Mumbai office based. • Medical scientific voice of expertise for assigned product(s) and relevant therapeutic areas. • Position provides medical scientific expert advice guidance to HCPs. • Facilitates information, education, and research activities for physicians and ancillary healthcare professionals regarding current and future therapies in development or commercialized by • Scientific exchange and professional relationship development with key opinion leaders. • Medical scientific input into marketing strategy and key commercial initiatives, • Develop and maintain in depth knowledge for assigned product(s) relevant therapeutic area(s) through attendance participation at key internal meetings training sessions, relevant congresses, and seminars and by regular self-study of the national international literature. • Provide expert medical scientific advice for assigned products and related therapeutic areas, including responding to requests for scientific technical information contribute to the development and medical and scientific accuracy of core dossiers. • Establish and maintain professional and credible relationships with key opinion leaders and academic centres this will involve participating in scientific congresses, coordinating advisory boards, round table meetings, discussion fora etc. • Deliver scientific presentations and medical education programs to healthcare professionals individually or in groups (meetings, clinical sessions, etc.). • Screen relevant literature and other information from relevant scientific societies meetings and conferences and develop summaries of key messages for dissemination. • Deliver training to sales forces and other departments develop and update relevant training materials. • Clinical Research Activities ,Design and implement clinical research projects within defined standards (e.g. Phase IV, post marketing clinical activities such as registry database projects, epidemiological surveys,), Provide the required oversight to manage review, approval and conduct of IIS studies. • Review and preparation of promotional material. Ensure the medical scientific content is correct and fully compliant with internal policies and guidelines. • Provide medical scientific input into marketing strategy and key commercial initiatives, as required. • Medical Writing & Communication Qualifucation • Mpharm/PhD (Pharmacology)/PharmD/BHMS/BAMS/BDS Experience • Minimum of 1-2 year in Medical Affairs. • Freshers with exceptional academic qualifications will be considered Skills • MS Office • Excellent Written &oral Communication skills • Disease/Therapy Knowledge • Business Acumen • Excellent Relationship Building Skills • Broad Understanding of Medical Affairs • Confidence to interact with Internal & External Stakeholders

Job Title: Evidence Synthesis & Medical Writing Job Location: - Gurgaon/Noida/Hyderabad Job Responsibilities: - Contribute to projects specific to Targeted literature reviews (TLR) / Systematic Literature reviews (SLR) / Value dossiers (GVD or AMCP) / Scientific publications (abstracts, posters, manuscripts) etc. Ensure to deliver at highest quality in stipulated timeliness Ensure data are presented in a clear, complete, accurate, and concise manner o Performs quality control (QC) checking / proof reading of assigned documents Excellent knowledge of systematic review methodology/HTAs submissions Experience of writing market access documents such as Academy of Managed Care Pharmacy (AMCP) dossiers and global value dossiers (GVD) Experience in the analysis and interpretation of data, including report writing, is essential Be accountable and responsible for assigned activities such as writing, reviewing, literature searches, project management etc. Support growth of the business through the development of strong client relationships Guide and mentor junior team members Qualification: - Masters degree, PharmD, PhD or equivalent in medicine / pharmacy 3-6 years of experience in HEOR and medical writing domains Knowledge of various reference management software (EndNote / Reference manager) Experience of conducting meta-analysis and network-meta-analyses (RevMan, STATA, R) Proficiency in Microsoft Word, Excel and PowerPoint Additional skills: - Understanding of economic evaluation techniques and basic health economic modelling (EM) knowledge o Understanding of real-world evidence (RWE) studies Understanding the market access environment and challenges globally o Excellent time management, project management and communication skills Interpreting data, writing reports, and making actionable recommendations Proactive approach to work, problem-solving aptitude and flexible to learn and adapt Primary research or conducting workshop with key opinion leaders (KOLs) Behavioural Attributes Ability to execute assigned tasks both independently and collaboratively with minimal supervision Proactiveness in identifying solutions to challenges Growth mindset demonstrated through intellectual curiosity, critical thinking, and a drive for collective business success Skills that give you an edge: - Strong analytical skills to solve and model complex business requirements are a plus. With life sciences or pharma background. Medical writing experience Meta-Analysis (RevMan, STATA, R) Gen AI/ML skills o Analytical thinking ability Time management skill We will provide (Employee Value Proposition) Offer an inclusive environment that encourages diverse perspectives and ideas Deliver challenging and unique opportunities to contribute to the success of a transforming organization Opportunity to work on technical challenges that may impact across geographies o Vast opportunities for self-development: online Axtria Institute, knowledge sharing opportunities globally, learning opportunities through external certifications o Sponsored Tech Talks & Hackathons o Possibility to relocate to any Axtria office for short and long-term projects o Benefit package: -Health benefits -Retirement benefits -Paid time off -Flexible Benefits -Hybrid /FT Office/Remote Behavioural Attributes Ability to execute assigned tasks both independently and collaboratively with minimal supervision Proactiveness in identifying solutions to challenges Growth mindset demonstrated through intellectual curiosity, critical thinking, and a drive for collective business success Skills that give you an edge: - Strong analytical skills to solve and model complex business requirements are a plus. With life sciences or pharma background. Medical writing experience Meta-Analysis (RevMan, STATA, R) Gen AI/ML skills Analytical thinking ability Time management skill We will provide (Employee Value Proposition) Offer an inclusive environment that encourages diverse perspectives and ideas Deliver challenging and unique opportunities to contribute to the success of a transforming organization Opportunity to work on technical challenges that may impact across geographies Vast opportunities for self-development: online Axtria Institute, knowledge sharing opportunities globally, learning opportunities through external certifications Sponsored Tech Talks & Hackathons Possibility to relocate to any Axtria office for short and long-term projects Benefit package: -Health benefits -Retirement benefits -Paid time off -Flexible Benefits -Hybrid /FT Office/Remote

Job summary The role involves creating accurate and engaging content for the company website, presentations, scientific articles, and other marketing materials. Key responsibilities include conducting literature research, compiling research and business data, collaborating with scientific and marketing teams, and reviewing content for clarity and accuracy. Candidates should possess at least a bachelors degree in chemistry or biological sciences, along with a minimum of 2 years of experience in content writing. Proficiency in MS Office and strong communication skills are essential. Familiarity with scientific writing styles and basic SEO principles is an added advantage. Role & responsibilities Create clear, accurate and engaging scientific articles, blog posts, and other written materials. Research and analyze scientific literature, business reports, journals, press releases, and other online resources to develop compelling scientific articles, website content and other marketing materials. Collate and structure scientific and technical data for use in documentation, presentations, and publications. Collaborate with graphics designers, content writers, animators, and subject matter experts to ensure content accuracy and relevance. Revise and amend work in response to feedback. Proofread and edit materials to ensure proper formatting, clarity, and grammatical accuracy. Support additional writing, marketing and content research tasks, as required. Carry out other relevant assignments allotted from time to time. Preferred candidate profile Bachelors or Masters degree in chemistry or biological sciences (Microbiology, Life Sciences, or Biochemistry) with at least 2 years of experience in content writing. Proficiency in MS Office suite (Word, Excel, PowerPoint) and basic software skills are a must. Familiarity with scientific writing styles and conventions. Strong written and verbal communication skills. Basic understanding of SEO principles and digital content writing is a plus. Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members. Analytical thinker with strong problem-solving skills and the ability to adapt to shifting priorities and deadlines. Excellent planning, organizational, and time management skills, with the ability to support and prioritize multiple projects. Willingness to learn and adapt in a dynamic work environment.

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

Job Responsibilities- Create and validate analytical datasets using on real-world data sources (e.g., claims data, electronic health records) based on study protocols and inclusion/exclusion criteria. Conduct descriptive and inferential statistical analyses (e.g., hypothesis testing, regression modelling, survival analysis) Develop and validate statistical algorithms for advanced data analyses (e.g., propensity score matching, machine learning) Contribute to the development of study protocols, statistical analysis plans, abstracts/posters, manuscripts, and study reports. Collaborate with cross-functional teams (e.g., epidemiologists, clinicians, biostatisticians) to design and execute RWE studies.

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.

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: 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.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

Job Description Position: Medical Specialist Purpose of this position: Reports to: Director Medical Communications / Team Leader – Medical Communication Job Location: Santacruz (E), Mumbai Qualification: MBBS - Medicine, Other Graduate - Any Specialization, PG - Any PG Course - Any Specialization, M.Pharma - Pharmacy, M.Sc - Any Specialization (Life Sciences, Biotechnology, Zoology, Botany, Microbiology etc.) Experience : 1-5 years; experience in medical/scientific writing preferred Job responsibilities & Deliverable: Develop innovative medical communications for our clients, which are leading MNC Pharmaceutical and FMCG Healthcare companies Understand the client's medico-marketing requirements, conduct extensive literature searches and develop communication with a scientific and creative flair Attend brainstorming sessions with the internal client servicing team Develop scientific content for communications across media including websites, videos, medico-marketing print material, scientific publications, CME collaterals, Flash presentations etc. Skills Required: Strong grasp of English grammar and composition, with an interest in creative writing Willingness to learn and adapt continuously Ability to work with internal and external teams – understanding requirements and evolving solutions

This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. EMS (Executive Medical Summary) Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects. Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration. Conduct effective document initiation meeting to ensure authoring team alignment and understanding. Build scientific-based rationale that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner. Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data. Coordinate expert/scientific reviews, collate reviewer s comments, adjust content of document as required based on internal/external input, and prepare final version. Ensure and coordinate quality checks for accuracy . Exhibit flexibility in moving across development and preparation of multiple document types. Influence or negotiate change of timelines and content with other team members. Work with internal and external experts to develop and prepare presentations. As needed, m ay build and manage relationships with vendors/alliance partners . Project and Stakeholder management Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents. Build/communicate credible writing project timelines . Anticipate and mitigate risks to delivery Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion. Effectively communicate project status to stakeholders Knowledge and Skills Development Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s). Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment. Maintain and enhance knowledge of regulatory guidelines and publication guidelines. Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews. Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms. Knowledge Sharing Provide coaching to others by sharing technical information, giving guidance, answering questions. Recognized for technical expertise in specific document development. Network with others (including other functions and regions) to identify and share best practices. Contribute to process improvements, suggesting opportunities where appropriate. Provide database and other tool (e.g., document management systems) expertise. Minimum Qualification Requirements: Bachelor s degree in a scientific, health, communications, technology health related field . Demonstrated experience in technical/ regulatory scientific writing . Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process ) Other Information/Additional Preferences: Graduate degree with formal research component or in life sciences. Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields . Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise). Experience writing regulatory, clinical trial documents and/or publications Experience writing deliverables for Medical Affairs communications (slide decks, patient or HCP materials, etc ) Experience in clinical development, clinical trial process or regulatory activities . Demonstrated project management and time management skills. Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

We are Hiring For Leading ITES Company for the position of PV Aggregate Reporting Role Job Descriptions 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: 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.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : PV Aggregate Mumbai (Job Code # 54) b) For Position in Pune Search : PV Aggregate Pune (Job Code # 55)

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

Overview We have an exciting role of Medical Writer to drive and translate creative and contemporary ideas to solid design and impact. You will have a key role in design and deployment of creative campaigns with our global clients, including many Fortune 50 companies. Responsibilities Lead and manage a team, providing guidance, mentorship, and support to ensure their professional growth and enhance the quality of output Develop a refined understanding of the brand, disease, and the overall therapeutic/treatment category. Ensure all content is created with appropriate tone, style, and structure based on brand strategy, creative brief, and client expectations Demonstrate a sound understanding of healthcare/pharmaceutical advertising communication requirements Ability to understand appropriate medical/technical documents (clinical studies, product monographs, publications) and translate them into compelling messages and content for a wide variety of audiences Demonstrate superior writing skills and a high level of professional craftsmanship (referencing, annotating) Familiar with modular content and omnichannel marketing - the ability to develop and maintain content matrix and core claims documentation Play the role of a leader when managing a team, exhibit leadership skills and motivate them when required Demonstrate ability to set priorities while handling multiple tasks Keep track resource allocation, and project progress, providing regular updates and reports to management Collaborate with clients and account managers to address feedback, incorporate changes, and ensure client satisfaction Manage multiple projects simultaneously, allocating resources effectively and maintaining effective communication with cross-functional teams and clients Conduct performance evaluations, identify training needs, and provide professional development opportunities for the design team Qualifications 11+ years of experience in healthcare communications agencies (AMA experience is preferred) Bachelor's degree or equivalent experience with a focus on pharma/science/medicine Portfolio containing work samples that demonstrate medical writing for a variety of communication forms (e.g., sales aids, direct mail, websites, social media) for a variety of audiences (e.g., healthcare professionals, patients, consumers) AMA Style Guide knowledge (certification not mandatory) Experience with referencing and annotating, and client MLR submissions requirements An ability to understand and process healthcare information Able to multi-task in a faced paced environment as a member of a highly collaborative team The desire to work with a diverse group of teams, projects, and clients Strong conceptual ability, standout creative thinking, and top-notch writing skills

Hi We are looking to hire Narrative Medical Writers for our Client. Please go through the JD and Apply Role : Graduate or post graduate in Pharmacy, Nursing or life sciences. Certification in Medical writing or Diploma in clinical research would be desirable. Preferred experience for the Author role: Preferably 1 to 2 years of experience in medical writing domain. Life science graduate with 1 to 3 years of experience Responsibilities of Author: 1. As per process requirement and assigned primary responsibility, support CSR patient narratives (draft and QC) 2. Ensure that the narratives are in accordance with the client SOPs, guidelines and agreed timelines and comply with client quality standards 3. Perform Quality check of the narratives according to the project specific checklist and against the source documents such as patient listing, concomitant medication listing, CIOMS form etc. and log defect in the defect tracker after analyzing the defect category 4. Attention to detail, work under stringent timelines on a need basis, and switch between different projects, as required 5. Be responsible for the quality and timelines of the deliverables as designated/allocated in the project. 6. Proactive communication with lead narrative writers to meet the narrative writing quality and timelines 7. Complete assigned training within stipulated timelines 8. Provide timely data (study tracker, quality metrics, billing numbers/effort hours) for preparing relevant (e.g. quality, TAT, effort hours, etc.) and project status updates, as defined by the client requirements To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 365 b) For Position in Bangalore Search : Job Code # 366 c) For Position in Hyderabad Search : Job Code # 367

Hi We are hiring for Leading ITES Company for PV Aggregate Reporting Profile. Skills a) Minimum 2 years of experience in Periodic/Scientific Aggregate Safety Report writing b) Experience is documents i.e., PBRER,PSUR,DSUR, ICH Guidelines b) Qualifications - Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician Job Responsibility Minimum 2 years of experience in Periodic/Scientific 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 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 Aggregate Safety Reports (PBRER, DSUR etc.) Eligibility: Minimum 2 years of medical writing work experience including 1 years of experience in periodic aggregate safety report writing (i.e. PBRER, PSUR, DSUR etc.) Working knowledge of MS Office applications Flexibility to work as per business requirements. Understands and interprets data/information and its practical application. Knowledge of industry and business principles related to biopharmaceutical products and combination products. Good interpersonal, verbal, and written communication skills Qualifications Health Care Professional OR Masters/bachelors degree in Life Sciences/Physician To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Mumbai Search : Job Code # 54 b) For Position in Pune Search : Job Code # 55

ql-editor "> Job Summary: The Report Writer is responsible for preparing high-quality scientific and technical reports, including clinical study reports (CSRs), bioanalytical reports, and regulatory submission documents. This role ensures that all reports comply with regulatory guidelines, industry standards, and internal SOPs while effectively communicating scientific findings. Key Responsibilities: Prepare and review scientific and technical reports, including clinical study reports, bioanalytical reports, and method validation reports. Ensure clarity, accuracy, and compliance of reports with regulatory requirements (FDA, EMA, ICH, etc.) and Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) standards. Work closely with scientists, analysts, statisticians, and quality assurance teams to interpret data and ensure accurate presentation of study results. Format reports as per client specifications and regulatory submission requirements. Maintain version control and track report progress to ensure timely completion of deliverables. Perform quality control (QC) checks on reports to identify inconsistencies, errors, or deviations from standard practices. Assist in the preparation of summaries, manuscripts, and other scientific documents for publication or regulatory submission. Stay updated with regulatory guidelines, industry best practices, and emerging trends in medical and regulatory writing. Qualifications Experience: Bachelor s/Master s degree in Life Sciences, Pharmacy, Biochemistry, or a related field. 2-6 years of experience in medical writing, regulatory writing, or scientific writing within a Contract Research Organization (CRO), pharmaceutical, or biotech industry. Strong knowledge of GLP, GCP, and ICH guidelines related to clinical and bioanalytical reporting. Excellent writing, editing, and proofreading skills with high attention to detail. Ability to interpret scientific data and present it clearly and concisely. Proficiency in Microsoft Office (Word, Excel, PowerPoint) and document management systems. Strong organizational and time management skills to handle multiple projects and meet tight deadlines. Preferred Skills: Experience with regulatory submissions, clinical protocols, and investigator brochures. Familiarity with statistical concepts and data analysis tools. Knowledge of electronic submission processes and regulatory writing software.