3 Safety Reports 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.,

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.,

Hi, We are hiring for leading ITES Company for Narrative Medical Writing Profile . Job Description Build and process submission dossiers of low-to-moderate complexity: Submission Dossiers that may be periodic (e.g.: safety reports) or minor amendments (e.g.: IND Amendment, DMF Amendment, CMC Update as appropriate to level, etc) or otherwise not major applications but in support of pending approvals or lifecycle commitments for marketed products (e.g.: meeting packages, responses as appropriate, Advertising and Promotion Submissions, routine labeling updates as appropriate, etc.). QC submission dossiers or parts of submission dossier output of low-to- moderate and moderate-to-high complexities as assigned. Other submission related requests could be assigned that are in support of general publishing but commensurate with role expectations. Role and Responsibilities: Utilize current electronic document management and publishing tools to prepare submission- ready Regulatory components and assemble, publish, and dispatch dossiers according to regulatory requirements for paper and electronic submissions with limited supervision Provide GRA component-level publishing support to ensure submission components conform to e-submission standards (e.g., templates, scanning, indexing) QC electronic and paper submissions to ensure compliance with company and agency requirements. Maintain effective interactions with all publishing contributors and responsible RA professionals, to ensure timely delivery of dossier components taking into consideration special requirements and needs; Maintain open and timely communication; and Determine the scope of the electronic publishing requirements for the dossier Apply appropriate JRD document and dossier standards, including adherence to a pre- established submission content plan Participate in special projects and process improvement initiatives. Global Regulatory knowledge of product registration procedures covering IND, NDAs, CTAs, BLA, IMPDs, MAAs for various countries including regulated markets like US, EU, Canada and Australia-NZ. Support regulatory submissions publishing for EDMF, COS/CEP for Drug substance related filing and regulatory submissions publishing in MRP, DCP, CP and National filing for the EU or Support regulatory submissions publishing for Annual reports, Safety Reports, updates to DMF, labeling, stability and CMC sections for US. Reviews and maintains regulatory database comprising existing and new regulations pertaining to submission requirements for the region. Regular interaction with internal stakeholders and external stakeholders like Local Affiliates/ MC (Marketing Company) through emails & teleconference, through proper communication channels to ensure accuracy and completeness of submission and resolving issues as and when they arise. Escalates unresolved issues appropriately as per the agreed escalation process. Ensures that the quality and TAT targets defined are always met. Experience Required: Two or more years of experience in pharmaceutical industry submission publishing or related technical skills Minimum 1-year hands-on experience in working with Documentum and industry leading publishing tools, preferably Liquent Insight Publisher is required Experience with word processing, use/applications of templates, bookmarking, hyper-linking, Microsoft Office applications is required Familiarity with FDA or EU regulations & guidelines is preferred Practical understanding of evolving technologies in support of business area is preferred Skills Required: The candidate should possess strong attention to detail, exhibit excellent interpersonal communications (in English, both verbal & written), organizational, time management and follow-up skills. The candidate must also demonstrate personal initiative, responsibility, flexibility, the ability to work under limited supervision, and be able to handle multiple project assignments Managing own work: ability to prioritize, plan and organize multiple assignments, and to work under strict timelines Global Regulatory Knowledge; familiarity with regulatory resources (i.e., location, interpretation and application of global regulations and guidelines relating to regulatory affairs) Basic understanding of information management concepts and tools needed to support business area. Use various technical skills to resolve publishing/document preparation issues. Ability to demonstrate a solid command of the technical tools at the level required to perform job duties Problem solving skills Management of team Knowledge of business principles. Key Skills: a) Grad or PG in Nursing, Pharmacy or Life Sciences b) 2or more years of experience in pharmaceutical industry submission publishing or related technical skills c) Familiarity with FDA or EU regulations & guidelines To Apply WhatsApp 'Hi' @ 9151555419 and Follow the Steps Below: a) For Position in Noida Search : Copy and Paste the link below https://outpace.in/job/regulatory-submissions-publisher-4/