SIRO Clinpharm Pvt. Ltd Released Job Openings On 30/07/2022.Siro Clinpharm is a drug development solutions provider to the global healthcare industry. Our subject expertise gives us an edge in clinical trial management, clinical data management, medical writing, biostatistics & statistical programming & pharmacovigilance. In 1996 Dr.Gautam Daftary founded SIRO in Mumbai, India. In 2001 company started providing its services in Data Management.
SIRO Clinpharm Pvt. Ltd Recruiting B.Pharma,B.Sc,M.Pharma,M.Sc,Any Graduate,Any Postgraduate Candidates with 06+ years of experience for Regulatory – Medical Writer (Narrative Writing) Position.Complete Details for the Regulatory – Medical Writer (Narrative Writing) as follows.
Important Details :
- Location : Hyderabad/Secunderabad, Mumbai (All Areas) (WFH during Covid)
- No of Vacancies:NA
- Details of Salary: NA
- Opening date for online Application: 30/07/2022
- Mode of application :Online
- How To Apply: Interested candidates can send CV to firstname.lastname@example.org
Job Description/Skills Required
- Senior regulatory medical writer to perform review and writing of the CSR narratives for different therapeutic areas including oncology.
- Senior regulatory medical writer to also perorm standalone QC, data QC and scientific review of other clinical documents like CSRs, protocols, IBs, eCTD and non-eCTD documents
- Senior regulatory medical writer to also perform writing and review of the transparency deliverables like protocol & result registries, lay summaries, redactions in accordance with documented guidelines, SOPs, and timelines.
- Perform above mentioned activities in compliance with established standards, performance metrics and with minimal oversight/ supervision.
- Perform project management and training coordination activities with minimal supervision from reporting manager.
Primary Duties and Key Responsibilities:
- Productivity and Efficiency:
- Draft and review regulatory medical writing documents (narratives, CSRs, Protocols, ICDs, IBs, Table of studies, eCTD/ summary documents etc.) in accordance with documented guidelines, SOPs, and timelines. Ensure that the data is objectively and accurately represented. Responsible for the final deliverable in terms of timelines and quality.
- Effectively lead assigned regulatory medical writing activities & build expertise across the different document types assigned through imparting medical/ clinical knowledge.
- Performs authoring /quality check/ review of transaparency deliverables like clinical trial disclosures (protocol registry forms and results summaries), lay summaries, redaction, data anonymization reports.
- Effective project management and optimal project utilization: ensuring maximum productivity per assigned work load and defined metrics.
2) Compliance to timelines, quality, processes & policies:
- Achieve high quality deliverables with minimal oversight and robust review process including addressal/ rationalisation of all review comments
- Ensure that documents are approved and issued as per timelines and comply with established quality standards and performance metrics
- Strict adherence to applicable processes and policies, including but not limited to applicable regulations, guidelines, policies, SOPs, WIs, process flows, templates, style guides, etc
- Ensure timely reporting of deliverables, project updates & prompt issue escalation to the line manager/project manager; perform any other responsibility assigned by Line Manager
- Timely and regular update of all tools and trackers; documentation and archival of deliverables; be prepared for any audits and inspections
3) Support new and existing business:
- Help diversify business by supporting strategies and business development efforts
- Develop and strengthen relationships with clients and prevent escalations by ensuring robust mitigation measures right upfront
- Support department promotional activities assigned by reporting manager/ business leads
- Be prepared for any audits and inspections with maintaining all systems and processes up to date