Covance Associate Medical Writing Coordinator in Bangalore, India

Job Overview

Work Location: Bangalore

Responsible for general maintenance of paper and electronic Medical Writing project files and archiving study documentation. Responsible for general maintenance of eTMFs and performing documentation quality checks. Assist Medical Writers in the archiving of clinical study protocols and CSRs and associated documentation.

Essential Job Duties:

These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.

  • Takes ownership for maintaining Medical Writing project files, eTMFs/TMFs in accordance with relevant regulatory requirements.

  • Works with Medical Writers to create and maintain Trial Master File Plan and Index.

  • Generate and maintain the eTMF tracker, working with Project Manager, study teams, and applicable business partners for reconciliation of the files as part of the quality control process.

  • Proactively maintains documents with the standardized filing structure for study documents,

  • Gathering, organizing, scanning and shipping of Medical Writings project documentation as required.

  • Perform archiving duties on all paper and electronic media storage.

  • Performing documentation quality checks, identifying and following up on quality issues with relevant Medical Writing staff.

  • Assist department management team with maintaining tracking tools and metric data.

  • Training and supporting others in study filing, archiving and eTMF practices

  • Assist Medical Writers in the formatting of draft CSRs, clinical study protocols and subject narratives by using Covance or Client-specific templates and style guides.

Top 3 reasons you should join us:

  1. Energizing purpose: Our work improves lives. Covance has helped pharmaceutical and biotech companies develop 100% of the top 50 prescription drugs in the marketplace today. You will personally contribute every day to advancing healthcare.

  2. Exceptional people: You will join a growing team of people who have a common goal for exceptional service and quality. You will learn from the most talented minds and subject matter experts, in an agile, supportive, and caring environment.

  3. Extraordinary potential: You will work in a most stimulating and a flexible work environment that will help you thrive personally and professionally.

Get to know Covance

Covance, a $15 billion Fortune 500 company, with operations in over 97 countries, has led the way in improving patient outcomes through visionary data sciences over the last five decades. We have supported 100% of the top 50 drugs in the market and all the oncology medicines approved in 2016. Our team of over 57,000 across the globe is committed to advancing healthcare and bringing new medicines to market sooner. Our unique perspectives, built from decades of scientific expertise and precision delivery, help our clients identify new approaches and anticipate tomorrow’s challenges as they evolve. Driven by a passion for excellence and a relentless commitment to quality, we unlock opportunities that advance innovation and deliver the promise of a healthier world. Together, with our large pharmaceutical and emerging biotech clients, Covance transforms today's health care challenges into tomorrow's solutions.

Over the years we have been recognised and applauded for our efforts in the creation of personalised medicines and innovative therapies to deliver on the promise of a healthier world. Some of our recent accolades:

  • LabCorp named in FORTUNE Magazine's 2018 list of ‘World’s Most Admired Companies”

  • Frost & Sullivan Best Practice Award – Asia Pacific CRO Growth Excellence Leadership Award

  • IMDiversity – Corporate Diversity Honor Roll

  • Flexjobs – Top 100 Remote Work – Company to Watch

  • Life Science Strategy Group – Rated as the CRO “Making the right moves to be successful in the future”

Tolearn more about our exciting opportunities in India, visit

Education/Qualifications

Education:

Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.

Experience

  • Strong English writing and communication skills.

  • Knowledge of Microsoft Office packages to include Outlook, Word, PowerPoint and Excel are essential.

  • Great attention to detail and will take leadership over the departments filing and archiving.

  • Must be very organized, self-driven and highly motivated.

  • Must be able to understand and follow good documentation practices.

  • Previous experience at managing high volumes of documentation paper or electronic would be favorable.

  • Previous work in a clinical or Medical Writing setting would be favorable.

  • Ability to work in a fast-paced setting with many interruptions.

Job Number 2018-16961

Job Category Clinical Operations

Position Type Full-Time

Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.