Covance Senior Medical Writing Lead, Manager in Bangalore, India
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:
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.
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.
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
Graduate or Bachelor’s degree in Life Sciences (or Pharma or related health discipline) from an accredited university or college.
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
Job Number 2018-16976
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.