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.

Emergence of Social Media - Communication Overview of Project Management Skills

Communication in Medical writing

Effective Medical Writing

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:

◦ 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:

“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:

• 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 :

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 :

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:

Project Planning

Project Implementation

Project Definition

Pr

ojec

t M

anag

emen

t

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

Templates

•Document specific

•Functional Specific

Standards & Guidelines

•Compliance guidelines

•Style Guide

Checklists

•Document Checklist

•Process checklist

•Performance checklist •Monitor and

Measure •Bring in Process Improvement

•Implement the processes

•Establish objectives processes

Plan Do

Check Act

Overview of Project Management skills

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

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

Thank You .. Questions please..

Presenter’s Email: drchandrababu@gmail.com

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