Job
Description
Greetings from You & I Consulting! You & I Consulting has always been in the spotlight for getting placed in 64+ MNC's PAN India. Hirings for MNC : - Great Opportunity in Giant MNC .Grab the Opportunity to grow and explore We are hiring for: Medical Writer CTC : upto 17 LPA Mode : Work From Office Location- Mumbai, Pune, Bengaluru Preferred experience for the role: • Overall ~5 years of authoring/editing experience in medical writing domain across different therapeutic areas in clinical documents including clinical study protocol, pediatric investigation plan, informed consent document, clinical study report, investigators brochure, clinical summary of pharmacology, clinical overview (efficacy and safety), briefing package/pre-meeting package preferred • Good knowledge of clinical research domain, ICH GCP principles, Common Technical Document (CTD) structure and regulatory requirements • Experience in preparation of clinical documents necessary for national and international regulatory submissions to the US, European and other regulatory agencies • Computer Literate: Knowledge of MS Word, PowerPoint, Adobe Acrobat, MS Excel, etc Responsibilities: • Setting, discussing and meeting expectations of the document during kick off and subsequent meetings Lead the authoring/editing of clinical documents, as mentioned above. Ensure adherence to established processes, timelines, regulatory guidelines and applicable standards, styles, guidelines Perform quality review of the clinical documents within established timelines with adherence to applicable guidelines, templates, and processes Ability to effectively and proactively communicate with internal and external stakeholders, including authors and key opinion leaders as appropriate (including problem-solving and resolution of issues) • As required, take on functional role and responsibilities of the role of Documentation Lead o Lead PDRD deliverables for project and act as first point of contact for any information that is required for content/document preparation Ensure alignment and content re-use across documents for a product Onboard lead document writers on document content alignment and timelines. Provide required source documents incl. information pertaining to study documentation, relevant project contacts (authors, reviewers), developmental strategy Actively participate in Regulatory Affairs Functional or other cross functional team meetings Review content of document prior to finalization to ensure high quality prior to initiation of author review or Expert Team Review Perks and benefits: ONLY 5 Days Work CAB Fecility Medical Benefits To Apply Call on 8250242229 (Puja) / Whats app on the same Number ***Though We Try and Answer The Calls Immediately, but Due to Heavy Call Flow The Below Numbers Might Be Busy At Times. In case you find the number busy, please WhatsApp your details to us in the below format: - 8250242229 (Puja) Name- Mobile number - Mail - Highest Qualification Highest qualification University Name Total work experience - Date of birth- Current Organization- Preferred Location Last CTC- Expected CTC: *Interested candidates can even refer their friends or relatives provided the criteria *FOR interview Call Now our HR Specialist: -----@ ** 8250242229 (Puja) (call or WhatsApp)
