1. Brief Overview
Dates : 26-28 November, 2015
Venue: : National Institute of Pharmaceutical Education and
Research (NIPER), Chandigarh
Title : Good Communication & Project Management Skills in Medical Writing
Presenter: Dr Chandra Babu
Deputy General Manager, Cognizant
Disclaimer: All opinions and thoughts in this presentation are that of the presenter only.
2. Emergence of Social Media - Communication
Overview of Project Management Skills
Communication in Medical writing
Effective Medical Writing
3. The process of communication is what allows us to interact with other people;
without it, we would be unable to share knowledge or experiences with anything
outside of ourselves. Common forms of communication include speaking, writing,
gestures, touch and broadcasting.
Wikipedia definition
No matter what job you have in life, your success will be determined 5% by your
academic credentials, 15% by your professional experiences, and 80% by your
communication skills.
Communication in Medical writing
Defining: Communication
A perspective:
4. ◦ Regulatory/Sponsor/Project teams
◦ Physicians/Statisticians/PK-PD Scientists
◦ Clinical trial leaders/Data managers
◦ Other contributors
◦ Emails (primarily)
◦ Instant messengers/communicators
◦ Teleconferencing/Video conferencing
◦ Share points (pertaining to data)
◦ Others (WhatsApp, social media etc ?)
Communication in Medical writing
Various Stakeholders:
Modes of Communication:
5. “A group of Internet-based applications that build on the ideological and
technological foundations of Web 2.0, and that allow the creation and exchange
of user-generated content.“
Electronic communication through which users create online communities to
share information, ideas, personal messages, and other content.
Kaplan, Andreas M. and Michael Haenlein . "Users of the world, unite! The challenges and
opportunities of social media," Business Horizons, 2010, 53 (1), 59 - 68
Federation of State Medical Boards. Model policy guidelines for the appropriate
use of social media and social networking in medical practice. April 2012.
Emergence of social media - communication
What is Social media:
How communication occurs:
6. • World wide connectivity
• Easier and faster to make connections and interactions
• Top social media platforms most often used by medical writers are
LinkedIn, Facebook, Twitter and You tube
• Primarily for, personal professional development, connect with
colleagues, seeking out latest news and information
• Medical writers value webinars and podcasts
Social media empowers employees in organizations through
• Dialogue
• Knowledge sharing and training
• Shared collaborative structure and approach
• Defining and implementing policies
• Strategic framework with business goals
Emergence of social media - communication
Why Social media:
How Social media is empowering :
7. Five steps to planning projects
1. Defining the work breakdown structure
2. Diagramming the network
3. Developing the schedule
4. Analyzing the time, efforts and cost-time trade-offs
5. Assessing risks
• Maintain timelines for all deliverables
• Ensuring milestones met
• Coordinate meetings and activities for teams (sponsor/CRO)
• Write and conduct Quality Control (QC) reviews
Overview of Project Management skills
Project Management Responsibilities – Medical Writer
Steps to Plan Projects :
8. It is a statement of all tasks that must be completed as part of the project
An activity is the smallest unit of work effort consuming both time and
resources
Schedule and control the activities
Assign an owner for each activity who is responsible and accountable for it
Top-down Approach
Use breakdown structure to identify structure of report
Identify sections, sub-sections
Target sections with data interpretation/analysis
Bottom up Approach
Appropriate for projects involving untested methods and approaches
Where no experience of a project
Brainstorm and generate all activities you can think needs to be done
and categorize
Overview of Project Management skills
Work Breakdown Structure:
Approaches to Medical Writing:
9. Project Planning
Project Implementation
Project Definition
ProjectManagement
Work Break-down
Resource Requirements
Objectives
Sequencing tasks
Contingency Planning
Assigning Responsibilities
Renegotiating and modifying
Evaluating
Overview of Project Management skills Clear Messaging
High quality
Compliance
Pyramid of
Key tasks - Achievable
Subtasks - Specific's
Sub Subtasks -Details
People
Process
Technology
Accountability
Primary Responsibility
Task and Subtasks
Establish Dependencies
Gantt charts with timescales
What could go wrong?
How to prevent it?
How to deal with it?
Results - Met /not Met
Process - Effective
Performance
Timescale
Technology
Other Resource
11. Quality Standards
> Identify relevant standards
> Select Indicators
> Set Goals and Targets
> Communicate Expectations
Quality Measurement
> Refine Indicators and Define measures
> Develop Data Systems
> Collect Data on Real-time basis
Reporting of Progress
> Analyze Data
> Feedback to MWs, updates to Leadership team
> Develop regular reporting cycle
Quality Improvement Process
> Use data for decision making and improving
policy
> Manage changes
> Implement value adds and PI’s
> Create a learning Organization
Quality
Management
Framework
Overview of Project Management skills
12. Good English (oral and written)
◦ Grammatically correct, comprehensive
Good Scientific/Analytical understanding
◦ Clinical, PK, PD, Statistics
Effective planning
◦ Having clarity in concept and responsibility
Ethics and Compliance
◦ Research and Publication Ethics – ICH & ICMJE
Confidentiality
◦ Subject privacy and regulatory requirements
Clear correct and concise presentation
◦ Simple, Specific, concrete
Effective Medical Writing
Essential Skills for Effective Medical Writing: Communication
13. Thank You .. Questions please..
Presenter’s Email: drchandrababu@gmail.com
14. Good Communication is an essential component of continuous growth. No
matter what job you have in life, your success will be determined 5% by
your academic credentials, 15% by your professional experiences, and 80%
by your communication skills. Entailing the details of effective
communication, its application in daily activities pertaining to medical
writing. Emergence of social media in communication, and leveraging it as
an advantage for medical writing.
Effective communication along with a good project management is key to
scientific writing which encompasses regulatory, safety, publication and
communication writing percepts. Overview of Project management with
special emphasis on defining planning and implementation of activities to
ensure timely delivery of high quality documents. The work breakdown
structure ensures all aspects of project tasks identified and along with a
meticulous contingency planning ensures no mess up of quality and
timeline in any eventuality.
Summary
