Sr. Regulatory Writer

4 weeks ago


India Mantras2success Consultants Full time
Job Description:

Role:

. Preparation and review of Electronic Common Technical Document (eCTD), PSUR. PADER or RMP in compliance with EU and US standards and protocols.

. Write, edit clinical study protocols. clinical study reports, summary documents, investigator brochures, portions of regulatory briefing documents and development safety update reports.

. Drafting and revising pre-clinical summaries.

. Quality control of documents for content, uniformity, adherence to ICH/FDA/EMEA or other appropriate regulatory guidelines. Ensure compliance with company or client SOPs and style guidelines.

. Write and maintain Standard Operating Procedures and Style Manuals for internal process and external process.

Requirement:

A PhD/Masters/Bachelor' s degree or expertise in one or more specialized subject areas In healthcare. medicine and research writing (AMWA/ EMWA certification will be a great value add).

Minimum 3 Years of experience as a Medical RWE Writer in HealthCare / Medical / HealthTech can apply for this position.



  • india Meril Full time

    We are currently seeking a highly motivated and experienced professional in Regulatory Affairs specializing in Medical Devices Domain to join our team. Positions are: Executive / Sr. Executive / Asst. Manager - Regulatory Affairs Experience: 3 to 9 years Location: Andheri east, Mumbai Working Days: 6 days (Mon-Sat) - WFO Responsibilities: 1. Dossier...

  • Senior Medical Writer

    1 month ago


    India Havas Life Sorento Full time

    THIS OPPORTUNITY IS WITH OUR GLOBAL TEAM.JOB SUMMARY:The Senior Medical Writer develops content for pharmaceutical and healthcare marketing and communications materials which may include promotional materials, video scripts, leave behinds, objection handlers, MOA visualization, patient profiles, and other promotion-related materials.The Sr Medical Writer is...

  • Senior Medical Writer

    1 month ago


    India Havas Life Sorento Full time

    THIS OPPORTUNITY IS WITH OUR GLOBAL TEAM. JOB SUMMARY: The Senior Medical Writer develops content for pharmaceutical and healthcare marketing and communications materials which may include promotional materials, video scripts, leave behinds, objection handlers, MOA visualization, patient profiles, and other promotion-related materials.The Sr Medical Writer...

  • Medical Writer Ii

    3 weeks ago


    India Syneos Health Clinical Full time

    **Description** **Medical Writer II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers...


  • india Unichem Laboratories Limited Full time

    Qualifications : B.Pharm/ M. Pharm/ M.Sc. Location: For two years in Brazil Office followed by Office in Mumbai Job description Responsibilities Ensure change management, post approval changes to ANVISA Review of technical documents for new submissions, post approval changes (Individual Protocol, HMP). Writing PATE for post approval changes Respond to...


  • India Vaco Full time

    Job Title: Sr. Compliance Engineer Work Type: 3 Month Contract Location: 100% Remote. Salary: OpenYOUR MISSION:The role of a Sr. Compliance Engineer is to work with our Trust and Compliance team to: Drive security compliance efforts from the beginning to the end by maintaining a positive relationship with both internal and external stakeholdersMaintain...


  • india Vaco Full time

    Job Title: Sr. Compliance EngineerWork Type: 3 Month ContractLocation: 100% Remote.Salary: Open YOUR MISSION: The role of a Sr. Compliance Engineer is to work with our Trust and Compliance team to: Drive security compliance efforts from the beginning to the end by maintaining a positive relationship with both internal and external stakeholders Maintain...

  • AMM Author

    2 weeks ago


    india Akkodis Full time

    We are seeking an experienced Aircraft Technical Writer with a strong background in Airbus manuals and hands-on experience with aircraft such as A320, A330, A350, and A380. The ideal candidate will have a comprehensive understanding of procedures and documentation standards. This role requires meticulous attention to detail, excellent communication skills,...

  • Sr Cloud SRE

    4 weeks ago


    india Deltek Full time

    22-Apr-2024 Sr Cloud SRE India-Remote 9265BR Company Summary As the recognized global standard for project-based businesses, Deltek delivers software and information solutions to help organizations achieve their purpose. Our market leadership stems from the work of our diverse employees who are united by a passion for learning,...

  • Mgr Med Writing

    2 weeks ago


    india Thermo Fisher Scientific Full time

    This position manages the performance and workload of Medical Writers and provides short-term and long-term resource planning in order to assign projects to appropriate and available staff. Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluates timeliness and...


  • india NextGen Healthcare Full time

    Description :We’re seeking an experienced Technical Content Strategist to join the Content Design team at NextGen Healthcare.As a technical content strategist, your key responsibility will be maintaining our strategic direction for the company’s technical content. You will also help determine the best content formats to improve consumer...

  • Sr. Biostatistician

    1 month ago


    India K3-Innovations, Inc. Full time

    (Must be flexible with US hours)We are seeking a talented and experienced Senior Biostatistician in solid tumor oncology and submissions to join our team. The successful candidate will lead statistical analysis efforts and provide strategic guidance on study design and data interpretation. The Senior Biostatistician will collaborate closely with...

  • Sr. Biostatistician

    1 month ago


    India K3-Innovations, Inc. Full time

    (Must be flexible with US hours) We are seeking a talented and experienced Senior Biostatistician in solid tumor oncology and submissions to join our team. The successful candidate will lead statistical analysis efforts and provide strategic guidance on study design and data interpretation. The Senior Biostatistician will collaborate closely with...

  • CMC Manager

    1 day ago


    india Vita Green Health Product Company Limited Full time

    Job Purpose: The position will be overseeing Chemistry, Manufacturing, and Controls (CMC) activities, ensuring the highest quality and compliance standards. Responsibilities will encompass a range of tasks, including technical writing, collaboration with manufacturing sites, and close coordination with Quality Assurance (QA) and Quality Control (QC)...

  • Safety Writer

    4 weeks ago


    india Thermo Fisher Scientific Full time

    Summarized Purpose: Responsible for the planning, coordination and delivery of safety writing services for multiple clinical trial and/or marketed product projects. Performs day-to-day safety writing and related activities within a highly regulated pharmacovigilance environment, driven by strict timelines. Activities include but are not limited to...

  • Sr. Product Manager

    4 days ago


    india Velbiom Probiotics Full time

    About VELBIOM Velbiom Probiotics is a research-driven microbiome research and probiotics marketing company based in Bengaluru. With over 30 years of experience in the probiotics market, we are India's first exclusively probiotic brand. Our team of researchers, doctors, pharmacists, and scientists utilizes a data-driven approach to provide the most effective...


  • India Tata SIA Airlines Full time

    **Job Overview** To assist in supervising and managing all aspects of Vistara operations and customer services at the airport including check-in, boarding, ramp handling, arrival and baggage services. Supervisory role also requires understanding of internal/ external stakeholder management with thorough knowledge of Emergency Response Planning **Key...


  • India Tata SIA Airlines Full time

    **Job Overview** To assist in supervising and managing all aspects of Vistara operations and customer services at the airport including check-in, boarding, ramp handling, arrival and baggage services. Supervisory role also requires understanding of internal/ external stakeholder management with thorough knowledge of Emergency Response Planning. **Key...

  • Sr. Attorney

    3 weeks ago


    india Cacti Global Full time

    Job Description Job Description We are a leading alternate legal service provider and talent management solutions company in our industry. Our company is looking for talented senior attorneys (Compliance Specialist ) to join our dynamic legal team. You will perform a range of duties including maintaining legal and regulatory compliance registers by...


  • india GMR Group Full time

    JOB PURPOSE Operate Helpdesk and monitor the facilities / allocation of resources and other activities in the Passenger Terminal building (PTB) while meeting / achieving established SOPs of a designated area and ensuring regulatory compliance at airport terminal in delivering ultimate customer satisfaction. The role will be the face of the...