7 Regulatory Writing Jobs

As a Medical-Regulatory Writer Assistant Manager, you will be responsible for planning and managing Medico-Regulatory Writing in compliance with applicable Regulatory Guidelines. Your duties will include providing high-quality medical and scientific writing, offering technical consultation and advice on strategy and regulations, demonstrating subject matter expertise, managing writing projects effectively to meet deadlines, collaborating with internal and external clients, and writing various types of reports such as CTD Modules, Safety Reports, and Aggregate Reports. You will also be required to conduct science reviews of aggregate reports, ensure document compliance with client specifications, attend project meetings, stay updated on regulatory guidance, maintain Aggregate Report Tracker, perform detailed searches on regulatory agency websites, mentor associates, and provide effective communication that leads to operational excellence. To qualify for this role, you should have a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience. An advanced degree is preferred, along with previous experience in the pharmaceutical/CRO industry. Additional qualifications in medical writing (AMWA, EMWA, RAC) would be advantageous. You should possess excellent data interpretation and medical writing skills, strong project management abilities, interpersonal and negotiation skills, and exceptional oral and written communication skills. Knowledge of global, regional, and national document development guidelines, along with proficiency in Microsoft Word, PowerPoint, and Excel, is essential. You should be able to work well in a team, handle pressure, and deliver quality work within tight timelines. Occasionally, you may need to work in different time zones. This position does not have any direct reports and is based in Gurgaon. If you meet the qualifications and possess the required skills and abilities, we invite you to apply for this challenging and rewarding role in the medical-regulatory writing field.,

RRD GO Creative is seeking experienced Medical Writers to join our team in Chennai. In this role, you will play a crucial part in developing high-quality and scientifically accurate medical and regulatory documents, such as clinical study reports, protocols, and brochures. Your responsibilities will also include creating clear and concise medical content tailored for healthcare professionals, regulatory agencies, and internal stakeholders. To excel in this role, you must conduct thorough research and literature reviews to ensure content accuracy and compliance with industry standards. Collaborating with subject matter experts, scientists, and regulatory teams is essential to develop compelling and compliant medical writing materials. You will be expected to adhere to client and regulatory guidelines, such as ICH, FDA, and EMA, while ensuring consistency, accuracy, and scientific integrity in all documents. As a Medical Writer, you will review and revise content based on feedback from reviewers and editors, manage multiple writing projects simultaneously while meeting strict deadlines and quality standards, and support quality control and peer-review processes to ensure excellence in medical documentation. Requirements for this role include a Bachelor's, Master's, or Doctorate degree in Life Sciences, Medicine, Pharmacy, or a related field, along with at least 3 years of experience in medical writing within the pharmaceutical, healthcare, or life sciences industries. A strong understanding of medical and scientific terminology, clinical research processes, and regulatory requirements is crucial. Additionally, excellent writing, editing, and verbal communication skills are necessary, with an eye for detail. Experience in preparing clinical and regulatory documents, publications, and scientific communications is preferred. You should be able to interpret and summarize complex scientific data for different audiences and possess familiarity with industry guidelines such as ICH, GCP, AMA, FDA, and EMA. Proficiency in Microsoft Office Suite and reference management tools is required, along with strong organizational skills, multitasking abilities, and the capacity to work independently under tight deadlines. Moreover, experience collaborating with cross-functional teams, including researchers, medical professionals, and regulatory experts, will be beneficial in this role. Join RRD GO CreativeTM, a company with over three decades of experience in business communications, marketing solutions, and digital productivity solutions. Our expertise in Global Brand Solutions, Smart Work Solutions, and Technology & Innovation Services enables us to transform the way businesses interact with customers, fostering strong brand loyalty. Our team of 8,000 experts across 42 locations collaborates across various industries to co-create a future-ready business landscape. We work with businesses to digitize every aspect of the Customer Journey, translating strategic visions of expansion and efficiency into superior Customer Experiences. Let us help you address customer needs effectively and make Customer Experience your competitive differentiator.,

The Medical-Regulatory Writer Assistant Manager will be responsible for planning and managing Medico-Regulatory Writing for Regulatory compliance in accordance with applicable Regulatory Guidelines. You will be tasked with providing high-quality medical and scientific writing services, from planning and coordinating literature searches to delivering final drafts to both internal and external clients. Your role will also involve offering technical consultation, substantive advice on strategy, regulations, and industry best practices, and demonstrating expertise in subject matter and therapeutic areas. In addition, you will need to effectively manage medical writing projects to ensure the delivery of quality products within agreed timelines. Collaboration with internal and external clients will be essential, along with tasks such as writing CTD Modules, Medical Data Packages, SmPCs, PIs, PILs, Safety Reports, Aggregate Reports, and other relevant documents. You will also be responsible for conducting science reviews of aggregate reports produced by PV Associates and ensuring that all document outputs and processes align with client specifications, templates, and style guidelines. Furthermore, the role requires attending project initiation meetings, maintaining awareness of current regulatory guidance and medical information techniques, updating Aggregate Report Tracker, carrying out cases reconciliation periodically, and conducting detailed searches on regulatory agency websites for safety alerts. Mentoring Associates, overseeing training plans, and enhancing the skills of existing team members will also be part of your responsibilities. The ideal candidate should hold a Master's degree in Pharmacology/Pharmacy/Medicine with at least 5 years of experience, although an advanced degree is preferred. Previous experience in the pharmaceutical/CRO industry is advantageous, along with additional qualifications in medical writing such as AMWA, EMWA, or RAC. Strong data interpretation, medical writing, and project management skills are essential, as well as excellent interpersonal, negotiation, oral and written communication skills. Proficiency in Microsoft Word, PowerPoint, and Excel, as well as the ability to work effectively in a team-oriented environment, are also required. This position may occasionally require working in different time zones as needed. There are no direct reports for this role, and the location will be in Gurgaon.,

Minimum Qualification Requirements: Bachelors degree in a scientific, health, communications, technology health related field. Demonstrated experience in technical/ regulatory scientific writing(CSR/Protocol writing/IB) Strong communication and interpersonal skills. Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

Serve as principal owner of the SARA deliverable and have responsibility for completion of the deliverable in compliance with all applicable service level agreements (SLA). Lead, author and finalize aggregate reports, including but not limited to PBRERs/PSUR, DSURs, PADERs, RMPs, ACOs, and line listings author responses to regulatory agency/ Pharmacovigilance Risk Assessment Committee (PRAC) inquiries, as required. Conduct/Lead ongoing literature safety surveillance for marketed and investigational products. Assist with the identification of ICSRs from literature, evaluation of events of special interests as well as aggregate data review. Act as Signal Management Lead on post-marketing and clinical trial projects. Set-up, implement, organize (including documentation) and lead safety management teams. Set-up and update products signaling strategies. Author and/or QC review all types of signal management deliverables. Lead/ conduct ongoing signal detection activities as per agreed signaling strategies, perform signal validation and signal evaluation analyses for proactive and timely identification of signals and characterisation of risks . Responsible for full documentation and tracking of signals. In a PV support role, lead/author and/or QC review safety responses to regulatory agencies/PRAC and justification documents to support labelling documents. Interface with clients and other functional groups within Lifecycle Safety and other business units, such as Regulatory affairs Reporting (RR), Real World Late Phase (RWLP), Medical Writing, Clinical Research, Quality, Knowledge Quality Management (KQM), Pharmacovigilance Support (PVS), Project Leads (PL), Medical Safety Advisors (MSA), Qualified Persons for Pharmacovigilance (QPPV) / Pharmacovigilance Contact at National Level (PCNL), Library Information Services (LIS), Safety Operations (SO), and Information Technology (IT), as needed. Participate in internal and external audits and inspections, as required. Contribute to achievement of departmental goals e.g. utilization realization and productivity metrics. Read, acknowledge and adhere to all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Serve as the interface between the global project lead and the working team conduct regular lessons learned with the working teams to ensure all information from the customer is cascaded to the relevant team members. Provide mentorship and training to less experienced resources. Provide regular reports to overall project manager and department management on project metrics, SOW changes, client requests or concerns participate in project review meetings with management communicate and document project issues to project team members and department management in a timely manner. Ensure Good Documentation Practices (GDP). Support and/or contribute to technology / innovation activities. Qualifications Bachelors Degree In a Scientific or Healthcare discipline Req 2 - 3 years relevant work experience. Pref Equivalent combination of education, training and experience. Req Excellent knowledge of Lifecycle Safety services and processes. Intermediate willingness and aptitude to learn new skills across Lifecycle Safety service lines. Advanced In depth knowledge and understanding of applicable global, regional, local regulatory requirements. Intermediate i.e. Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and International Conference of Harmonization (ICH) guidelines, SOPs. Intermediate Proven ability to meet strict deadlines. Advanced manage competing priorities and ability to be flexible and receptive to changing demands. Intermediate Excellent organizational skills and time management skills. Intermediate Good working knowledge of Microsoft Office and web-based applications (e.g., Word, Excel, Powerpoint). Intermediate Good knowledge of medical terminology. Intermediate Proven ability to follow instructions/guidelines, work independently and on own initiative. Intermediate Excellent attention to detail and accuracy maintaining consistently high quality standards. Advanced Excellent written/verbal communication and report writing skills. Intermediate Sound judgment. Intermediate independent thinking and decision making skills. Intermediate Self-motivated and flexible. Advanced Ability to establish and maintain effective working relationships with coworkers, managers and clients. Intermediate Effective mentoring and coaching skills. Intermediate Good understanding of operational metrics, productivity and initiatives. Intermediate Demonstrate effective project management and leadership skills. Intermediate

What you will do In this vital role you will serve as the operational head for a team of Global HEOR Value Writers (L5) supporting Amgens global market access and reimbursement. This role is accountable for ensuring the timely and high-quality development of payer- and HTA-relevant deliverables including Global Value Dossiers (GVDs), AMCP dossiers, early HTA briefing books, reports and scientific publications across multiple therapeutic areas. The Global HEOR Value Writing Leader aligns closely with the Global Head HTA Strategy & Project Management and the Global HEOR Product Leads on plans and timelines for the relevant deliverables. Lead, handle, and mentor a team of Global HEOR Value Writers, fostering a high-performance culture. Lead all aspects of development, review, and quality control of value writing deliverables including GVDs, AMCP dossiers, early HTA briefing materials, reports and scientific publications across multiple pipeline and inline products. Align with Head HTA Strategy & Project Management to ensure deliverables follow product strategy and deliverable timelines. Align with the relevant Amgen processes. Serve as an expert on payer- and HTA-relevant writing materials. Collaborate with Head HTA Strategy & Project management to implement process improvements to speed up delivery of payer- and HTA-relevant materials. Contribute to hiring, training, and performance evaluations within the team. Ensure compliance with all regulatory and quality policies and standards. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The HEOR Value Writing Leader we seek should possess these qualifications. Basic Qualifications & Experience: Doctorate degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 2 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Masters degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 8 to 10 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Bachelors degree in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 10 to 14 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting OR, Diploma in health economics, public health, pharmacy, life sciences, biostatistics or a related field and 14 to 18 years of experience in HEOR, Medical or Regulatory writing in the pharmaceutical, biotech, or consulting setting Proven experience in leading the development of GVDs, AMCP dossiers, and other HTA-related documents. 3+ years of experience in team management capacity. Skills & Competencies: Strong leadership and team management abilities. Excellent English oral and written communication, with ability to tailor content to different key partners. Advanced understanding of clinical, economic, and real-world data and their application in market access. Expertise in global HTA processes, payer evidence requirements, and value demonstration standard methodologies. Knowledge of Good Publication Practice and publication submission process Proficiency in Microsoft Office and reference management tools (e.g., EndNote). Innovative use of artificial intelligence to boost efficiency. Organizational Behaviors: Proactive, collaborative, and solutions-focused leadership style. Strong project management and decision-making capabilities in a dynamic, distributed team environment. Comfortable working in a distributed team across time zones and cultures.

Hi Hiring for the leading ITES Company for Regulatory 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 Job Description: 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