26 Regulatory Documents Jobs

As an Executive - Clinical Development at QED, your primary role is to plan and conduct clinical trials. You will be responsible for producing various clinical trial documents, such as protocols, investigator brochures, study manuals, and monitoring plans. Key Responsibilities: - Manage clinical trial sites by conducting routine monitoring visits to ensure compliance with GCP guidelines, company SOPs, and approved protocols - Monitor the progress of the project and ensure enrollment targets are met - Protect the rights and well-being of human subjects - Ensure the accuracy, completeness, and verifiability of reported trial data from source documents - Recruit Investigators and negotiate budg...

Job Title: Senior Medical Writer Location: MS Clinical Research (MSCR), Department: Medical & Scientific Affairs Reporting To: Director Experience Required: Minimum 10 years in medical/scientific writing Engagement Type: Consultant Part-time/Project-based/Remote Role Summary: MSCR is seeking a highly experienced Senior Medical Writer to oversee the medical writing function and mentor a growing team of in-house writers. This strategic role will involve managing complex writing projects, reviewing and enhancing document quality, and providing expert guidance to ensure scientific accuracy, regulatory compliance, and writing excellence across all deliverables. Key Responsibilities: Lead and mana...

Role Overview: As a Principal Medical Writer at GSK, you will be responsible for developing high-quality clinical and regulatory documents to support the mission of advancing healthcare and getting ahead of disease. You will collaborate with cross-functional teams to ensure the delivery of accurate, clear, and impactful content aligning with global regulatory standards. This role presents an exciting opportunity to enhance your expertise, lead projects, and make a meaningful impact on patients" lives. Key Responsibilities: - Independently lead preparation of complex clinical and post-market safety documents such as DSURs, PSURs/PBRERs, ACOs, PADERs/PAERs, RMPs, and responses to regulatory au...

Role Overview: You will provide medical expertise for site identification, study feasibility, study design, conduct, analysis, and reporting. Your responsibilities will also include the generation of integrated databases, pooled analyses for efficacy and safety, ISE and ISSs, as well as dossiers for regulatory submissions for market authorizations of new medicinal products, diagnostics, and devices. Key Responsibilities: - Define regulatory strategies for submission of clinical trial applications, approval, and marketing trial applications in targeted regions such as India, U.S, and EU. - Prepare and review regulatory documents, dossiers containing technical, preclinical, and clinical data i...

Medical Affairs Writer JD 1. Writing, editing, reviewing, formatting, publishing regulatory (clinical and post marketing) documents and dossier sections in a manner compliant with FDA, EMA, CDSCO, ICH, CONSORT guidelines and other similar standards. 2. Collaborating with the clinical team in developing and strategizing the Clinical Development Plan. 3. Collaborating across line functions in preparing SOPs for Regulatory documents. 4. Interpreting, representing and summarizing clinical and scientific data 5. Planning, organizing, tracking, and archiving clinical and post-marketing regulatory dossiers. 6. Managing stakeholders across line functions and geographies. 7. Managing assigned individ...

As a Senior Clinical Operations Specialist (Senior CTA) at Syneos Health in Athens, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include: - Assisting Clinical Monitoring staff with site management activities, acting as a Sponsor representative for assigned sites, and ensuring compliance with protocol requirements and study procedures. - Creating and maintaining project files, handling project correspondence, and participating in file audits. - Preparing and updating site manuals, reference tools, and other documents. - Inputting clinical tracking informatio...

As an R&D Executive at PTC - MORAIYA, your role will involve the following key responsibilities: - Preparation of Literature Search Report for various jurisdictions including USA, Australia, Brazil, China, and EMB markets - Preparation of Freedom to operate opinion for various jurisdictions including USA, Australia, Brazil, China, and EMB markets - Patent and Design Application Drafting and Prosecution - Identification of new product feasibility - Prior art searches for preparing patent invalidation ground - Trade dress and device related IP analysis - Support for litigation activities including e-discovery/paper discovery - In-house IP Portfolio Management - Preparation and review of IP rel...

You will be responsible for performing comprehensive Quality Control (QC) review of clinical sections of regulatory documents to ensure the highest quality from technical, regulatory, and compliance perspectives. This includes verifying all references and source data, ensuring internal consistency within documents, and documenting QC findings appropriately. Additionally, you will be involved in content QC of clinical data/reports across different therapeutic areas, development phases, modalities, and geographic regions. - Conduct comprehensive QC review of clinical sections in regulatory documents such as IBs, INDs, NDAs, BLAs, CTAs, MAAs, and briefing packages for regulatory agency meetings...

Description Senior Medical Editor (Editing and QC of Regulatory Docs) Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with ...

As a Regulatory Affairs Specialist, you will be responsible for maintaining accurate records of regulatory submissions, approvals, and correspondence with regulatory agencies. You will have the following key responsibilities: - Prepare, review, and submit regulatory documents, including applications, reports, and renewals, to relevant regulatory agencies. - Determine the types of regulatory submissions or internal documentation required for situations such as proposed device changes. - Develop and implement regulatory strategies to ensure compliance with domestic and international regulatory requirements. - Monitor regulatory changes and updates closely, assess their impact on current and fu...

Please find the JD attached below for your reference.Position Scientific Writer / Regulatory WritingExperience- 3-5 Years Sr. Associate/ 7-9 Years – Lead / 10+ years- Associate ManagerLocation- Bang, Hyd, Mumbai, Pune, Delhi NCR (Hybrid-2 day WFO) Full time position Job Description – Regulatory Writing / Medical Writer : The Scientific and Medical content teams at work on different projects across the product life-cycle from regulatory, safety, medical affairs and commercial solutions for our clients. The team leverages the clinical and scientific knowledge and applies to various business problems to reach to various target audiences like the physicians, patients across different therapy are...

You will be responsible for the following key tasks: - Develop, write, and edit various scientific manuscripts, review articles, case studies, and conference abstracts/posters. - Prepare regulatory and clinical documents such as clinical study reports, investigator brochures, patient information leaflets, and regulatory dossiers. - Create medical communication materials including slide decks, CME content, and white papers tailored for healthcare professionals. - Collaborate effectively with researchers, clinicians, and regulatory teams to ensure accuracy, consistency, and compliance with journal/regulatory requirements. - Conduct thorough literature reviews and ensure precise referencing usi...

Role Overview: As a Medical Writer at RRD GO Creative, you will be responsible for developing high-quality and scientifically accurate medical and regulatory documents, including clinical study reports, protocols, and brochures. Your role involves creating clear and concise medical content tailored for healthcare professionals, regulatory agencies, and internal stakeholders. Conducting thorough research and literature reviews to ensure content accuracy and compliance with industry standards is essential. Collaboration with subject matter experts, scientists, and regulatory teams is crucial to develop compelling and compliant medical writing materials. You will also need to adhere to client a...

Role Overview: You will be responsible for handling complex Medical Writing projects, providing review support for medical writing deliverables, training junior writers, and authoring a broad set of different clinical document types that support regulatory filings. Your role will also involve leading cross-functional teams, understanding the clinical development process, and possessing effective communication, time management, organizational, and interpersonal skills. Key Responsibilities: - Prepare and review clinical study reports, protocols, investigator brochures, submission documents, and other regulatory documents on investigational drugs in various stages of clinical development. - Ap...

Role Overview: You will be joining as a Senior Associate/Specialist Document Coordinator, supporting the Global Medical Writing Team in delivering its portfolio effectively and efficiently. Your main responsibilities will include managing the quality review of clinical and regulatory documents, such as Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, Clinical Summary documents, PBRER, DSUR, and RMP. Key Responsibilities: - Conduct quality review of clinical and regulatory documents - Participate in meetings related to medical writing, quality control, and compliance activities - Collaborate cross-functionally to continuously improve medical writing processes - Famil...

As a Cosmetic Regulatory Affairs Assistant at our company in Jodhpur, you will play a crucial role in ensuring that our cosmetic products meet all regulatory requirements and standards. Your attention to detail and proactive approach will be essential in supporting the Regulatory Affairs department. Key Responsibilities: - Ensure compliance with all relevant regulatory standards and guidelines. - Monitor changes in legislation and the regulatory environment, and take necessary actions. - Assist in collecting and reviewing raw material documents. Qualifications & Skills: - Bachelor's degree in Pharmacy, Chemistry, Cosmetic Science, or a related field. - Previous experience in regulatory affai...

Job Description for Medical Editor Job Summary: We are seeking a highly skilled Medical Editor who will be responsible for reviewing, editing, and ensuring the quality and accuracy of medical and scientific documents. This role involves working closely with medical writers and subject matter experts to produce clear, consistent, and compliant content for publication or regulatory submission. Key Responsibilities: Editing Medical Writing Deliverables Types of Deliverables Research articles (primary/secondary), review articles, case reports, editorials, perspectives, short communications, abstracts, posters, oral presentations, visual abstracts, publication cards (static/interactive/video), pu...

The Clinical Reporting Unit at Novo Nordisk is seeking a skilled and experienced individual to join their team. As a Medical Writer, you will be responsible for performing high-complexity medical writing tasks and acting as a project manager. Your role will involve planning, developing, and overseeing various regulatory documents, including Protocols, Clinical Trial Reports, Investigator Brochures, and Regulatory response documents. Additionally, you will lead discussions, drive project strategy, and ensure clear communication of clinical data. In this position, you will also be expected to contribute to process improvements, knowledge sharing, and mentorship of other medical writers. Mainta...

We are looking for talented Scientific writers with a strong drive for results and enthusiasm for content creation, publication process, and healthcare to join our dynamic team. If you have a knack for breaking down complex medical concepts and transforming them into clear, concise content, we would love to have you on board. Key Details: Experience: 3-5 years of experience in medical writing with a proven record of delivering high-quality, accurate content. Salary: Competitive salary with attractive incentives for each assignment. Positions Available: 3 (on-site, Dr. D.Y.Patil Medical College, Hospital & Research Centre) Roles & Responsibilities: Utilise your scientific knowledge to profici...

As a Senior Clinical Operations Specialist (Senior CTA) in the Hybrid model in Athens at Syneos Health, you will play a crucial role in ensuring compliance with Corporate and Clinical Operations Policies, Standard Operating Procedures, and Work Instructions. Your responsibilities will include assisting Clinical Monitoring staff with site management activities, maintaining project files, handling project correspondence, participating in file audits, and preparing and maintaining site manuals and reference tools. Additionally, you will be responsible for updating clinical tracking information into databases, tracking documents, managing the shared mailbox, and coordinating site supplies and ma...

Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COAs and othe...

Summary The Senior Regulatory Coordinator (Sr. RC) works under close supervision to support for development including line extension and /maintenance projects through development, registration, and approval including post approval commitments. To maximize operational effectiveness, Collaborate with RA GDD Development Units, RA GDD CMC, Regional Representatives (MoW, LACan, EU, China, Japan), Novartis Technical Operations (NTO), and Quality Assurance to align on planning, execution, communication, and completion of assigned projects. About The Role Key Responsibilities Ensure procurement of various key regulatory components (e.g. ordering certificates, GMP, registration samples, COAs and othe...

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You will be responsible for providing support for medical safety management within the Patient Safety & Pharmacovigilance department. This includes conducting medical review and assessments of Individual Case Safety Reports (ICSR), aggregate reports, co-authoring safety documents, and assisting in providing safety input to regulatory and clinical documents, as well as ad-hoc Health Authority queries. Your role will involve creating quality deliverables within agreed timeframes and maintaining a high standard of accuracy in compliance with patient safety business rules, standard operating procedures, and global and local regulatory requirements. Additionally, you will be supporting in definin...

You are on a mission to change the future of clinical research. At Perceptive, you will play a crucial role in helping the biopharmaceutical industry bring medical treatments to the market faster. Your mission is to change the world, and to achieve this, your contribution is essential. Apart from job satisfaction, Perceptive offers you a range of benefits including health coverage such as a medical plan for you and your dependents, personal accident insurance, life insurance, and critical illness cover. In terms of wealth, you can expect a competitive salary structure, a Flexi basket, a 12% provident fund, and a gratuity scheme. Furthermore, Perceptive is committed to investing in your perso...