hireejobs
Register for Job
Hyderabad Jobs
Banglore Jobs
Chennai Jobs
Delhi Jobs
Ahmedabad Jobs
Mumbai Jobs
Pune Jobs
Vijayawada Jobs
Gurgaon Jobs
Noida Jobs
Oil & Gas Jobs
Banking Jobs
Construction Jobs
Top Management Jobs
IT - Software Jobs
Medical Healthcare Jobs
Purchase / Logistics Jobs
Sales
Ajax Jobs
Designing Jobs
ASP .NET Jobs
Java Jobs
MySQL Jobs
Sap hr Jobs
Software Testing Jobs
Html Jobs
IT Jobs
Logistics Jobs
Customer Service Jobs
Airport Jobs
Banking Jobs
Driver Jobs
Part Time Jobs
Civil Engineering Jobs
Accountant Jobs
Safety Officer Jobs
Nursing Jobs
Civil Engineering Jobs
Hospitality Jobs
Part Time Jobs
Security Jobs
Finance Jobs
Marketing Jobs
Shipping Jobs
Real Estate Jobs
Telecom Jobs

Senior Medical Writing Consultant

3.00 to 5.00 Years   Delhi   12 Jul, 2023
MMSH Clinical Research Pvt Ltd
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaMedical Transcription
EmploymentTypeFull-time

Job Description

    • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
    • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials and publications to medical journals
    • Complete writing assignments in a timely manner
    • Maintain timelines and workflow of writing assignments
    • Practice good internal and external customer service
    • Highly proficient with styles of writing for various regulatory documents
    • Expert proficiency with client templates & style guides
    • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
    • Contribute substantially to, or manages, production of interpretive guides
    • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
    • Mentor medical writers and other members of the project team who are involved in the writing process
    Requirements
    • At least 3 years of previous experience in the pharmaceutical industry
    • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
    • The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
    • Substantial Oncology experience required
    • Substantial clinical study protocol experience, as lead author, required
    • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
    • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
    • Understanding of clinical data
    • Exceptional writing skills are a must
    • Excellent organizational skills and the ability to multi-task are essential prerequisites
    • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
    • Experience being a project lead, or managing a project team
    • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
    • Substantial clinical study protocol experience, as lead author, required
    • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
    • Not required, but experience with orphan drug designations and PSP/PIPs a plus
    ,

Keyskills :
global healthclinical practicesclinical protocols

APPLY NOW

Senior Medical Writing Consultant Related Jobs

© 2019 Hireejobs All Rights Reserved