Medical Writing Competency Model and Professionalism

Medical Writing Competency Model and Professionalism
Session 8B, Wednesday March 15, 8:00-9:30am Medical Affairs and Scientific Communications Forum 2017 March 13-15, Tucson, AZ Medical Writing Competency Model Content Medical Writing Competency Model Application Medical Writing Certification David Clemow, PhD, MWC Advisor Scientific Communications Strategy Eli Lilly and Company Eileen Girten, MS Principal Medical Writer inVentiv Health

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Medical Writing Competency Model Content
March 13-15 Tucson, AZ David Clemow, PhD, MWC Advisor Scientific Communications Strategy Eli Lilly and Company

MW Competency Model Content – Agenda
Introduction to competency Background on model Content organization Work functions Knowledge, skills, abilities, behaviors (KSABs) Additional information © 2017 DIA, Inc. All rights reserved.

Introduction – What is Competency
The ability of an individual to perform a job successfully A competent professional Is qualified to perform a specific role Has ability to perform a specific role Uses combination of KSABs to perform job successfully Hanging a plaque on the wall that says medical writer No; thus, Competency model (define the profession) Certification development (test individual on competency) © 2017 DIA, Inc. All rights reserved. KSABs = knowledge, skills, abilities, behaviors

Introduction - What is a Competency Model
Defines what competence looks like for a given profession Outline of functions (tasks, activities) that person in role must perform to be successful Professionally agreed upon list of KSABs that define successful job performance © 2017 DIA, Inc. All rights reserved. KSABs = knowledge, skills, abilities, behaviors

Background – Model History
Developed by Drug Information Association (DIA) Medical Writing (MW) Community Working Group Edition 1 approved 2009 Edition 2 approved February 2017 Breadth of experienced MW professional contributors 27 edition 2 contributors/reviewers 419 cumulative years combined professional MW experience Multiple global regions, companies, industry sectors, role settings © 2017 DIA, Inc. All rights reserved. MW = medical writer

Background – Contributors Edition 2
Name Organization Bert Wagner Janssen Linda Wood MedWrite Christopher Marshallsay Grünenthal Lisa Toth Eli Lilly Dan Benau University of the Sciences Michael Mihm Astellas Darryl L’Heureux Bristol-Myers Squibb Nancy Katz Illyria David Brown AstraZeneca Nina-Maria Vasconcelos Novo Nordisk David Clemow Norihisa Sakiyama Devjanighosh Dasgupta Cognizant Robin Whitsell Whitsell Innovations Eileen Girten inVentiv Shobha Gopalakrishnan Freelance Writer Frank Hubbard Global Regulatory Writing Solutions Susan Bairnsfather EPharmaTech Helle-Mai Gawrylewski Tatyana Wanderer Synchrogenix Hiroko Ebina ProScribe Thomas Schindler Boehringer Ingelheim Janet Stoltenborg Yeshi Mikyas MedImmune JP York Galderma Yumiko Aoyama Kim Green © 2017 DIA, Inc. All rights reserved.

Background – Model Scope
Purposely inclusive to include scope/breadth of profession Covers competencies across wide range of situations All content is not relevant for an individual Focus on what applicable to individual based upon need Does not distinguish competencies of novice from experienced Can be used to develop secondary tools to delineate Situation Example 1 Example 2 Type of writer Regulatory Publication Information need Role Communication Training Plan Setting (niche) Industry Freelancer © 2017 DIA, Inc. All rights reserved.

Background – Changes from Edition 1
Updated entire content Simplified introduction, improved clarity, changed format Added abbreviations, certification competency backbone Content Type Edition 1 Edition 2 Functions 9 7 Tasks 28 29 Activities 93 130 KSABs 91 128 © 2017 DIA, Inc. All rights reserved. KSABs = knowledge, skills, abilities, behaviors

Background – Changes from Edition 1
Added scientific communications strategy work function and associated tasks/activities Incorporated strategic communications function Changed doc management and multi-doc coordination work functions to document project management Combined development and sharing into 1 function © 2017 DIA, Inc. All rights reserved.

Background – Get a Copy Hand out today
DIA MW Community collaboration site: file library Will be published later in 2017 (DIA or AMWA journal) © 2017 DIA, Inc. All rights reserved.

Skills/Abilities/Behaviors
Content Organization Work Functions Tasks/Activities Knowledge Skills/Abilities/Behaviors 3 distinct but overlapping ways to show competencies Additional Information © 2017 DIA, Inc. All rights reserved.

Content Organization – Work Functions
Task 1 Task 2 Task 3 Activity 1 Activity 1 Activity 1 Activity 2 Activity 2 Activity 2 Activity 3 Activity 3 Activity 3 © 2017 DIA, Inc. All rights reserved.

Content Organization – KSABs
All Medical Writers Knowledge K1 K2 Skills / Abilities S/A1 S/A2 Behaviors B1 B2 Regulatory Writers Publication Writers Manager of Writers Knowledge K1 Knowledge K1 Knowledge K1 K2 K2 K2 Skills / Abilities S/A1 Skills / Abilities S/A1 Skills / Abilities S/A1 S/A2 S/A2 S/A2 Behaviors B1 B2 KSABs = Knowledge, Skills, Abilities, Behaviors © 2017 DIA, Inc. All rights reserved.

Content Organization – Additional Information
General Abilities All Medical Writers Certification Competency Domains Abbreviations © 2017 DIA, Inc. All rights reserved.

Work Functions with Selected Task Examples
New More Senior Role Scientific communication strategy Develop strategic plans for key message development and mapping Continuity, alignment, synergy across documents, products, regions, functions Develop strategic plans for key message dissemination Core Role Document preparation, development, & finalization Author document, integrate cross-functional input, and ensure document communicates necessary information Revise document while facilitating issue resolution © 2017 DIA, Inc. All rights reserved.

Integral to Success Document project management Develop, coordinate, oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities Proactively establish a cohesive team to facilitate document delivery Demonstrate leadership during conflict, disagreement, timeline delays Document template, standard, format, & style development & maintenance Gather, review, and analyze resources to produce templates/guides © 2017 DIA, Inc. All rights reserved.

Outsourcing, alliance partner, & client management Ensure governance and communication infrastructure in place, including operational principles and associated tools Develop partner assessment program Knowledge, skill, ability, & behavior development / sharing Elicit and respond to competency-related feedback Process improvement Identify, collect, evaluate quantitative metrics to optimize performance in a data-driven manner New © 2017 DIA, Inc. All rights reserved.

KSABs with Selected Examples
All medical writers •Deliver written/visual communications that tell a scientific narrative •Author content for cascade-level messaging S •Industry guidelines •Project management techniques •Science •Communication techniques •Act with the highest ethical standard •Demonstrate judgment-based thinking K B Regulatory writers •Prepare regulatory submission communication strategy • Prepare documents for e-publishing S •Standardization initiatives (eg, ICH) •Regulatory authority regulations/guidance K KSABs = knowledge, skills, abilities, behaviors © 2017 DIA, Inc. All rights reserved.

Publication writers •Prepare publication plan strategy • Prepare publication documents S •Publication guidelines (eg, GPP3) •Reporting guidelines (eg, CONSORT) K Managers of writers •Create quality and compliance plans •Provide risk management • Strategically develop writing function S •Business planning process •Resource management •Influence without authority • Provide cultural sensitivity and manage across cultures K B © 2017 DIA, Inc. All rights reserved. KSABs = knowledge, skills, abilities, behaviors

Additional Information
General Abilities Ability Example Cognitive abilities attention to detail Communications skills written expression Work habits time management Soft skills openness to feedback Example © 2017 DIA, Inc. All rights reserved.

Medical Writing Competency Model Application
March 13-15 Tucson, AZ Eileen Girten, MS Principal Medical Writer inVentiv Health

How Managers Can Use the Competency Model
Hiring Training Setting expectations and goals Performance evaluation Retention Career ladders © 2017 DIA, Inc. All rights reserved.

Hiring Use to write clear job description
© 2017 DIA, Inc. All rights reserved.

Hiring – Sample Job Description
Responsibilities Write a variety of regulatory documents Coordinate quality review of documents Provide input on data analysis planning and interpretation Qualifications Strong computer skills, project management skills, and a high attention to detail Strong oral and written communication skills What type of regulatory documents? Such as? What programs? © 2017 DIA, Inc. All rights reserved.

Hiring – Revised Job Description Responsibilities
Write and edit protocols, clinical study reports, and integrated summaries of safety and efficacy Participate in document strategy sessions, including messaging, document flow, logic, and consistency for assigned projects Gather, review, analyze, and evaluate sources of information with appropriate guidance from products teams Interpret and explain data generated from a variety of sources, including research documents and tables, figures, and listings © 2017 DIA, Inc. All rights reserved.

Hiring – Revised Job Description Responsibilities
Perform literature searches as needed for drafting document content Coordinate the review, approval, and publishing of regulatory documents and ensures appropriate evidence of review and approval is maintained Communicate timelines, the writing process, and roles and responsibilities with the team members Maintain strong knowledge of global regulations and guidances associated with regulatory document preparation and submission © 2017 DIA, Inc. All rights reserved.

Hiring: Revised Job Description Skills and Abilities
Has strong written and verbal communication skills Possesses good attention to detail. Can find and correct errors in spelling, punctuation, grammar, consistency, and accuracy Able to accurately interpret data and communicate scientific concepts and numerical data in a clear and concise matter Has strong Microsoft Office skills (especially Word, PowerPoint, Excel, and SharePoint) © 2017 DIA, Inc. All rights reserved.

Hiring: Revised Job Description Skills and Abilities
Adapts to challenging deadlines and changing requirements Good interpersonal skills Knows global regulatory requirements and guidances associated with clinical regulatory document preparation and submissions Has experience with Common Technical Document content templates © 2017 DIA, Inc. All rights reserved.

Hiring Create checklists/screening tools
© 2017 DIA, Inc. All rights reserved.

Hiring Abilities Checklist Knowledge Score Skill Behavior Competency 1
Competency 2 Competency 3 © 2017 DIA, Inc. All rights reserved.

Hiring Abilities Checklist Knowledge Score Skill Behavior
Knowledge of global regulations and guidances Prepare regulatory submission communication strategy Communicate effectively Scientific communication techniques and principles Author quality, compliant documents specific to audience needs Manage multiple tasks Expertise in Microsoft Word, Excel, and PowerPoint Interpret data results from statistical outputs Adapt to changing, complex environment © 2017 DIA, Inc. All rights reserved.

Hiring Create checklists/screening tools to
Assess skills and abilities of potential job candidates Ask competency-linked interview questions © 2017 DIA, Inc. All rights reserved.

Training Identify training needs Metrics Audit findings
Client feedback Writers © 2017 DIA, Inc. All rights reserved.

Training Use model to develop trainings Back to the basics Onboarding
New processes and new technology © 2017 DIA, Inc. All rights reserved.

Setting Expectations and Goals
Writer and manager agree on expectations Writer’s self-assessment Relating job description and MW competencies Setting goals in Professional Development Plan © 2017 DIA, Inc. All rights reserved.

Setting Expectations and Goals
Explain how will writer be measured against these expectations Writer competencies Metrics/key performance indicators Formal and informal feedback © 2017 DIA, Inc. All rights reserved.

Performance Evaluation
Feedback Survey Work Function: Document Project Management 5 Excellent 4 Good 3 Average 2 Below Expect 1 Unacceptable Task  Activity 1 Activity 2 Activity 3 Activity 4 © 2017 DIA, Inc. All rights reserved.

Performance Evaluation
Feedback Survey Work Function: Document Project Management 5 Excellent 4 Good 3 Average 2 Below Expect 1 Unacceptable Develop, coordinate and oversee a completed work plan  Discuss tasks, subtasks, and roles and responsibilities Develop timelines Critical Activity 3 Critical Activity 4 © 2017 DIA, Inc. All rights reserved.

Retention Retain good employees Clear expectations
Base assignments on writer’s competencies and interests Provide resources and training Get writers involved Facilitate environment of knowledge sharing © 2017 DIA, Inc. All rights reserved.

Career Ladders Update job descriptions
Increasing level of skills, abilities, and experience Role Abilities Medical Writer Senior Medical Writer Principal Medical Writer © 2017 DIA, Inc. All rights reserved.

Career Ladders Update job descriptions
Increasing level of skills, abilities, and experience Role Abilities Medical Writer Write documents within a team environment Senior Medical Writer Evaluate, analyze, and interpret medical literature with minimal supervision Principal Medical Writer Serve as a medical writing lead for submission-related documents Cross-functional team Educate writers on possible career paths © 2017 DIA, Inc. All rights reserved.

How Writers Can Use the Competency Model
Career Development Professional Development Training Developing best practices Mentoring © 2017 DIA, Inc. All rights reserved.

Career Development Monday night quarterback Assess our competencies
Identify new skills, processes, and technologies Discuss regularly with manager Opportunities for professional development © 2017 DIA, Inc. All rights reserved.

Professional Development
Think locally In-house professional development Best practices Think globally Professional organization conferences/workshops (eg, DIA, AMWA) Volunteer – DIA Communities © 2017 DIA, Inc. All rights reserved.

Training/Best Practices
Create trainings to develop and improve knowledge, skills, and abilities in the model Based on gap analysis New process New technology Enhance skill set Develop best practices © 2017 DIA, Inc. All rights reserved.

Mentoring Use SME list based on competencies to assign writers a topic to present Create a library of shared learnings/tutorials Pair experienced writer with junior writer Maintain SME list for writers © 2017 DIA, Inc. All rights reserved.

Closing Thoughts Incorporate model into hiring-retention lifecycle
Collaboration between manager and writer Expand business development Look at the big picture © 2017 DIA, Inc. All rights reserved.

Medical Writing Certification
March 13-15 Tucson, AZ David Clemow, PhD, MWC Advisor Scientific Communications Strategy Eli Lilly and Company

Medical Writing Certification – Agenda
What is certification Certification commission Certification exam backbone Competency domains and KSAs DIA MW Competency Model link to exam backbone Competency and its Testing Audience Discussion KSAs = knowledge, skills, abilities © 2017 DIA, Inc. All rights reserved.

What is Certification Medical Writer Certified™ = MWC Certification
Certificate For individual Assessment process Education process Professional experience needed Newcomers and experienced Awarded by 3rd party standards organization Awarded by educational program Competency measured by standardized test Complete a course(s) Standard set via defensible job analysis process outlining required knowledge/skills Variety of ways content set (eg, instructor) Designation to use with name Documented certificate Ongoing requirements to maintain Demonstrates knowledge at given time Medical Writer Certified™ = MWC © 2017 DIA, Inc. All rights reserved.

Certification Commission
Manages development and execution of certification policies and procedures Adheres to best practices and legally-defensible guidelines Supported by AMWA But independent Guided by SMT, a credentialing service vendor AMWA = American Medical Writers Association SMT = Schroeder Management Technologies © 2017 DIA, Inc. All rights reserved.

Certification Commission
Responsible for administration of reliable & content-valid credentialing program Oversees certification application, examination, and recertification Represents professional diversity and stakeholder voice Develops and revises the certification examination Activities Job analysis Exam assembly & administration Standard setting & scoring Item writing Item analysis Item banking © 2017 DIA, Inc. All rights reserved.

Competency Model Linked to Certification Exam
Certification Exam Backbone – Links Competency Model Linked to Certification Exam DIA MW Competency Model Certification Competency Domain / KSAs Exam Backbone Exam Questions contributed equal linked Job Analysis •Defines the profession (practices, expertise, expectations) •Establishes assessment content and standardized testing foundation •Ensures accuracy of KSA exam backbone •Links assessment and practice •Provides legal defensibility of certification process survey job descriptions, educational curricula, articles, guidelines, expert opinion, competency model © 2017 DIA, Inc. All rights reserved. KSAs = Knowledge, Skills, Abilities

Certification Exam Backbone - Domains
Competency Domains Evaluating Organizing Gathering Presenting Interpreting Focused on frequency of applicability across settings as well as testability Focus from DIA Comp Model WF2: Document preparation, development, & finalization WF3: Document project management (but also pulls tasks/activities from other model areas) KSAs: All medical writers (but also pulls KSAs from regulatory and publication) 16% ethics 19% 19% 19% 27% Weighted © 2017 DIA, Inc. All rights reserved.

Certification Exam Backbone – Selected KSAs
Link Exam with Competency Model Exam Backbone Excerpts from Competency Model 1. Gathering Thoroughly gather…pertinent resources Determining purpose of document Establish…strategic purpose Identify context for document Evaluate…quality, including relevant content, context Identify target audience Ensure team plans will meet target audience…requirements Select appropriate output type Make the document fit-for-purpose (eg…output type, outlet/venue type) Identify appropriate outlet type 2. Evaluating Evaluate content and organization Evaluate information Evaluate pertinent resources and data Perform fact or data checks Quality review…fact or data check Identify inconsistencies in data or other content presented Ensure team messaging…do not present an…inconsistent…argument Conduct critical review of a draft Disseminate good quality check and review practices Evaluate for completeness, fair balance, and absence of bias Evaluate… for…completeness and fair balance Learning competency model content is helpful preparation for certification exam! © 2017 DIA, Inc. All rights reserved. KSAs = Knowledge, Skills, Abilities

Certification Exam Backbone – Selected KSAs
Link Exam with Competency Model Exam Backbone Excerpts from Competency Model 3. Organizing Organize the appropriate…research literature Develop an outline Organize and outline document architecture Apply templates and guidelines to documents Train writers/authors on the use of templates, guidelines Determine structure of tables and figures to best communicate data Design… appropriate stand-alone, caption-styled figures and tables Design project work plan Develop, coordinate, and oversee…completed work plans Track progress and status of project Hold regular meetings…provide status updates 4. Interpreting Analyze, distill, and interpret data Comprehend relevant medical and scientific content Comprehend, interpret, and communicate scientific concepts Interpret clinical and numerical data Draft…medical messages that address data interpretation Derive key message(s) Develop product and disease state key messages Revise or repurpose content Author content for…repurposing Respond to reviewer's comments Facilitate…author-reviewer disagreement resolution 5. Presenting Deliver written, visual, and oral presentations Present the message logically and coherently Build convincing…arguments…using logic Communicate statistical content appropriately Communicate statistical concepts…in…clear, and concise manner Build persuasive and science-based arguments Use persuasive presentation and communication techniques Apply proper mechanics Edit documents…style and mechanics Apply principles of visual presentation Data visualization to improve message understanding © 2017 DIA, Inc. All rights reserved. KSAs = Knowledge, Skills, Abilities

Competency and its Testing
Competency is demonstrated through… Action in variable situations and context Outcome of getting job done with quality, speed, value Certification exam does not… Have a written portion (currently) Test ability to execute KSABs Prove competence, expertise, or guarantee future success KSABs = knowledge, skills, abilities, behaviors © 2017 DIA, Inc. All rights reserved.

Expert Knowledgeable practitioner Value Competency Practitioner Beginner Novice demonstrated by action and documented in performance review Experience © 2017 DIA, Inc. All rights reserved. Figure concept: Karen Woolley, ProScribe Woolley_Karen_Competency_110509

certification exam test knowledge not execution
Competency and its Testing Unconsciously Competent Consciously Competent Value Competency Practitioner Consciously Incompetent ? Unconsciously Incompetent ? certification exam test knowledge not execution 2 years experience and letters of recommendation before can apply for MWC Experience Medical Writer Certified™ = MWC © 2017 DIA, Inc. All rights reserved. Woolley_Karen_Competency_110509

Certification does… Test core foundational knowledge of KSAs via examination Essential knowledge for success in work place (but not sufficient) Demonstrate breadth of knowledge Understanding of fundamental principles in medical writing field Require continuing education for recertification Knowledge of current best practices Identify professional medical writer vs someone just looking for job Benchmark for practioners Roadmap for beginners or those changing specialization area Show commitment to profession Build resume Certification Value Proposition © 2017 DIA, Inc. All rights reserved. KSAs = Knowledge, Skills, Abilities

Domain / KSA Example of Medical Writing Settings Patient Education Pharmaceutical Regulatory Clinical Research Publication Medical Education Gathering: Elicit information from stakeholders Evaluating: Evaluate information with regard to audience, context Organizing: Apply templates and guidelines Interpreting: Synthesize and integrate information Presenting: Develop clear, concise prose and visuals © 2017 DIA, Inc. All rights reserved. KSAs = Knowledge, Skills, Abilities

Domain / KSA Example of Medical Writing Settings Patient Education Pharmaceutical Regulatory Clinical Research Publication Medical Education Gathering: Elicit information from stakeholders interview clinical experts, patients collect input from medical, statistics, regulatory collect input from principal investigator, co-author, statistician seek input from review committee, accreditation vendor Evaluating: Evaluate information with regard to audience, context ensure information suitable and useful for patients evaluate content for appropriate level of evidence ensure references are support line of evidence confirm content meets educational objectives Organizing: Apply templates and guidelines use factsheet, Q&A, news article template health literacy guides use clinical study report template ICH guidelines develop IMRAD outline CONSORT guide complete needs assessment ACCME guidance Interpreting: Synthesize and integrate information summarize condition, treatment information summarize key safety, efficacy conclusions communicate how study hypothesis was supported by data integrate clinical guidelines and current evidence to address educational needs Presenting: Develop clear, concise prose and visuals write, edit, review content © 2017 DIA, Inc. All rights reserved. KSAs = Knowledge, Skills, Abilities

How to become certified Have bachelor’s degree Minimum of 2 years full-time paid work experience or equivalent Review website About the MWC, apply, prepare subsites Review applicant/candidate handbook Resume, transcripts, 2 x letters recommendation Application and examination fee Prepare (study) Take exam 125 multiple choice exam in English Recertify every 5 years Continuing education credits or re-examination Not dependent on region, niche, or AMWA affiliation Medical Writer Certified™ = MWC © 2017 DIA, Inc. All rights reserved.

Audience Discussion Use of competency model
Career ladders, job descriptions, mentoring, and career development…other? Merits/value of certification Employers, freelancers, young in career, changing companies or job, vendor writing staffs…? Important to identify professional MW vs someone just looking for a job? How get industry buy-in? © 2017 DIA, Inc. All rights reserved.

Medical Writing Competency Model and Professionalism

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