Covance

  • Senior Medical Writing Lead, Manager

    Job Location(s) IN-Bangalore | IN-Bangalore
    Job Number
    2018-16976
    Job Category
    Clinical Operations
    Position Type
    Full-Time
  • Job Overview

    Work Location: Bangalore

     

    Responsible for preparation and coordination of complex clinical study protocols and clinical study reports (CSRs), and other documents as needed. Responsible for preparation of submission level documents. Provide review and feedback on documents prepared by the department. Performs the scientific review of clinical study outlines, protocols, statistical analysis plans, tables, figures and listings, and CSRs, ensuring high scientific integrity and correct data interpretation where applicable for all of these products.  Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate. Production of scientific publications and other documents (e.g., abstracts, posters, manuscripts, etc.). Provides technical leadership with responsibility for delivering Medical Writing Services to clients and internal Covance project teams. Ensure timely delivery of high quality documents to internal customers and Sponsors. Scientific presentations both internally within Covance and externally (e.g., conferences). Represents the company at scientific meetings and meetings with clients. Works with the management team to provide project leadership, guidance, mentoring and training to Medical Writers to ensure best working practices are maintained. Foster excellent working relationships with all clients, both internal and external, with the highest quality of service in a cost-effective manner on time, every time.

     

    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.
    • Write and coordinate the development of protocols, CSRs or other clinical documents of any complexity
    • Takes the lead in preparing submission level documents
    • Act as leader of Medical Writing team on large-scale (multiple document) writing projects, as appropriate, with support from management. Influence teams to adhere to the relevant medical writing requirements for projects
    • Produces scientific papers, abstracts and/or posters, and presentations.
    • Effectively manage multiple assignments in parallel, ensuring adherence to quality, timelines and budget requirements
    • Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
    • Act as medical writing lead and liaison for major clients and partners
    • Represent company at scientific and medical writing forums
    • Keep up to date with developments in Medical Writing
    • Demonstrate detailed knowledge of Medical Writing industry requirements such as ICH and regulatory agency guidelines
    • To regularly demonstrate initiative and ability to deal with medical writing situations independently. Present solutions and convince management and teams to adopt recommended strategies
    • Lead Medical Writing initiatives to develop and improve processes, including new technologies. Persuade other department staff to accept and embrace new working practices
    • Mentor staff and provide guidance and training to department
    • Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences
    • Write and review Covance SOPs and associated documents
    • Represent department in audits and inter-department working groups
    • Comply with Covance internal processes and procedures
    • Performs other duties as assigned by Management

     

     

    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”

    To learn more about our exciting opportunities in India, visit www.Covance.com/IndiaCareers

    Education/Qualifications

    Education:

     

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

    Experience

    Experience:

    • Typically minimum 6 years medical writing experience, including 3 years as medical writing project lead
    • Excellent command of written and spoken English
    • Excellent written and verbal communication skills
    • In-depth knowledge of MS Word
    • Excellent organizational and time management ability
    • Excellent knowledge of ICH guidelines applicable to medical writing and other regulatory guidances
    • Excellent understanding of medical/scientific terminology, data analysis and interpretation
    • Appreciation of the business requirements of a contract research organization

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