Medical Writer- Aggregate Reporting
5 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 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 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 skills - Excellent 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.
-
Aggregate Report Writer
4 days ago
Delhi, Mumbai, NCR, Pune, India Primus Global Technologies Full time ₹ 9,00,000 - ₹ 12,00,000 per yearMedical Writer (Aggregate Report Writer) •Experience: 2-6 years •Role: End-to-end authoring of complex deliverables including periodic aggregate reports (PBRERs, DSURs, SUSARs, PADERs/PAERs, ACOs, RMPs, and regulatory/safety reports) • Qualification: BPharm/Pharm D/M Pharm or any Life Sciences Degree.LocationsMumbai: Goregaon Pune: Baner NCR : still...
-
Content Writer
1 week ago
New Delhi, India Asian Institute of Medical Sciences Full time**Roles and Responsibilities** Medical writers are involved with preparing a range of documents for the submissions, including protocols and final reports for clinical trials,expert reports, preparation of manuscripts for publication in medical journals.contact No. +91-XXXXXXXXXX **Perks and Benefits** Key Skills - content writer - Blog WritingContent...
-
Medical Writer
2 days ago
New Delhi, India ValueLabs Full timeJob descriptionThe Medical Writer will be responsible for preparing high-quality clinical, regulatory, and scientific documents that support drug development and regulatory submissions.Experience : 1+ yearsLocation : Hyderabad (Work from office)Roles & Responsibilities:- Draft, review, and finalize clinical study protocols, investigator brochures, informed...
-
Medical Writer
49 minutes ago
New Delhi, 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 the...
-
Medical Writer
5 days ago
New Delhi, India Fusion Market Research Full time**Medical Writer Roles and Responsibility** - Creating, proofreading and editing regulatory and clinical documents, Investigator brochures. - Directly involved in medical marketing of new FDA drugs, pharmaceutical products, equipment through writeups, blogs, information handouts/leaflets, etc. - Coordination with physicians, scientists and healthcare...
-
Medical Writer Ii
3 days ago
Delhi, India PrimeVigilance Full timeCompany Description We are PrimeVigilance (part of Ergomed PLC), a specialised mid-size pharmacovigilance service provider established in 2008. We are proud to have achieved global organic growth year after year, with staff based across Europe, North America and Asia all covering services within: Medical Information, Pharmacovigilance, Regulatory Affairs...
-
Medical Content Writer
5 days ago
Delhi, Delhi, India Easy Wipe Full time**Job description** WE HAVE SOME POST VACANT FOR THE PROFILE OF (**Medical Content Writer**) Job Location: - Delhi Post For: - **Medical Content Writer** Experience minimum 4 TO 8 YEAR **Key Responsibilities**: - Develop high-quality medical content, including regulatory submissions, clinical study reports, scientific manuscripts, and educational...
-
Senior Medical Writer
7 days ago
Delhi, India PrimeVigilance Full timeCompany Description We are PrimeVigilance part of Ergomed Group a specialised mid-size pharmacovigilance service provider established in 2008 We are proud to have achieved global organic growth year after year with staff based across Europe North America and Asia all covering services within Medical Information Pharmacovigilance Regulatory Affairs and...
-
Medical Writer
15 hours ago
Delhi, 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...
-
Content Writer
2 weeks ago
New Delhi, India First Choice Consultant Full time**Profile: Medical Content Writer** **Exp: 2 years** **Salary: 20000 to 28000** **Location: Dwarka More, New Delhi** **6 Days working** **Time: 10 AM to 7 PM** **Key Job Responsibilities**: Experience in Medical Related Content - Develop and execute innovative content ideas for different online and offline mediums, which create a high brand recall...
