Medical Writer- Aggregate Reporting
6 days ago
Job Insights:Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety teamResponsibilities:Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations.Responsible for end-to-end authoring of complex deliverables - periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports, send documents for review on a timely manner, liaise with subject specific stakeholders, set up review comments resolution meetings when needed, facilitate QC process, reference linking, ensure documents are submission-ready before facilitating approval and handover of the document. Perform review to validate accuracy and relevance of the data presented in all the documents against the source data or references used in the document. Perform QC review of documents (Data discrepancy/inaccuracy, misinterpretation of data, missing data, improper sentence structuring, inconsistency of data[text/number] within the document, Grammatical errors, typos, inconsistency/non-compliance to client-specific style)Ensure that clinical documents adhere to current global standards, US Food and Drug Administration (FDA), ICH and Good Clinical Practices (GCP) guidelines and are in accordance with electronic publishing standards.Qualifications:Medical/M. Pharm/Pharm D/Life sciences degreeMinimum 2 years’ experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reportsMust have:Knowledge of regulatory documentation, drug development process and global regulations and guidelines.Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook).Excellent written and verbal communication skillsExcellent organizational and time management skillsEOE: Our client is an Equal Opportunity Employer, committed to a workplace free from discrimination and harassment. Employment decisions are based on business needs, job requirements, and individual qualifications without regard to race, color, religion, gender, age, disability, sexual orientation, gender identity, marital status, military service, genetic information, or any other status protected by law.
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Medical Writer- Aggregate Reporting
7 days ago
Bangalore, India Theron Solutions Full timeJob Insights: Our client is seeking an ambitious and energetic Medical Writer for the authoring of aggregate safety reports to join their Safety team Responsibilities: Responsible for the entire life cycle of the document and accountable for maintaining quality and timeliness, and compliance to internal/client SOPs and regulations. Responsible for end-to-end...
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Associate Medical Writer
4 weeks ago
Bangalore, Karnataka, India Novo Nordisk Full timeBy continuing to use and navigate this website you are agreeing to the use of cookies Accept Close Press Tab to Move to Skip to Content Link Search by Keyword Search by Location Loading Category Select how often in days to receive an alert Select how often in days to receive an alert Associate...
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Medical Writer
6 days ago
bangalore, India Theron Solutions Full timeQualifications:· Medical/M. Pharm/Pharm D/Life sciences degree.If you are a highly motivated individual with a passion for communication and a desire to make a difference in the healthcare industry, we encourage you to apply for this exciting opportunity.Your impact: About you:· Minimum 2 years’ experience in medical writing or equivalent experience in...
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Medical Writer
20 hours ago
bangalore, India 72 Dragons Full timeWe are looking for a Health Professional (Medicine, biotechnology, pharmacy, nursing, microbiology, dentistry, or biomedical sciences), to join our health writing team. This is a full-time position in India. The candidate must have a health and science background and experience writing in-depth medical content. The writer will be responsible for creating...
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(Only 24h Left) Safety Aggreg Report Manager
4 weeks ago
Bangalore, Karnataka, India IQVIA Full timeJob Overview Act as a stand-alone global functional lead at a project level applying experience knowledge and expertise for Safety Aggregate Report and Analytics SARA Center deliverables including but not limited to safety aggregate reports literature surveillance signal management activities and benefit risk management documents Actively contribute to...
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Senior Medical Writer
1 week ago
Bangalore, Karnataka, India IQVIA Full timeIQVIA is looking for candidates who have expertise in regulatory writing to join our Real World Evidence team The Ideal candidate will have 5-12 years of experience working as Regulatory Medical Writer adept in developing and authoring clinical study protocols informed consent documents clinical study reports Expectations Familiarity with the structural and...
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Senior medical writer
1 week ago
Bangalore, India Theron Solutions Full timeQualifications : · Medical/M. Pharm/Pharm D/Life sciences degree. Minimum 2 years' experience in medical writing or equivalent experience in life sciences domain with experience in End-to-End authoring of periodic aggregate reports, including PBRERs, DSURs, SUSAR, PADERs/PAERs, ACOs, RMPs, and ad-hoc regulatory and safety reports Knowledge of regulatory...
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Medical Doctor
4 days ago
bangalore, India The HIRD Full timeJob Title: Medical Reviewer / Medical Quality Reviewer Location: Pune | NCR | Kolkata Working Model: Hybrid Qualifications: MBBS (Medical Degree), preferably with a postgraduate qualification. Minimum 2+ years of experience in clinical practice or pharmacovigilance (PV). Must hold valid Medical Doctor certification/licensure in the country of service....
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Medical Doctor
4 days ago
bangalore, India The HIRD Full timeJob Title: Medical Reviewer / Medical Quality ReviewerLocation: Pune | NCR | KolkataWorking Model: HybridQualifications:MBBS (Medical Degree), preferably with a postgraduate qualification.Minimum 2+ years of experience in clinical practice or pharmacovigilance (PV).Must hold valid Medical Doctor certification/licensure in the country of service.Experience in...
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Medical Writer
2 weeks ago
Bangalore, India Jobted IN C2 Full timeOverview: We have an exciting role of Medical Writer - Manager 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. About US We are an integral part of Annalect Global and Omnicom Group, one of...
