What competence in pharmaceutical medical writing consists of

The Pharmaceutical Medical Writing Competency Model describes the work, knowledge, skills and behaviours needed for pharmaceutical medical writing. Writing is its essential core skill, supported by document management, scientific judgement, coordination, collaboration and continuing development.

The model and its scope

Competency means the ability to perform a specific role successfully through a combination of knowledge, skills and behaviour; a competency model records the professionally agreed requirements for successful performance and usually the activities involved. ^{1, 2} Writing differentiates medical writers from other pharmaceutical professionals, but is not sufficient for competent performance. ²

The DIA Medical Writing Special Interest Area Community working group developed the model in 2009, with contributions from pharmaceutical companies, contract research organisations, niche vendors and freelancers in the United States, European Union, Japan, Australia, India and other regions. ^{1, 3} Version 1.4 was made available to DIA members in June 2009; its core content was published in 2011, omitting some introduction, supervisor competencies and additional general abilities for space. ² It represents the contributors’ professional opinions rather than an official position of DIA or their employers. ²

Version 1.4 has two components: nine work functions with behavioural benchmarks and critical activities, followed by technical knowledge, skills, abilities and behaviours for all writers and additions for regulatory and publication writers. ² The earlier 2009 description also identified supervisors as a group with specific requirements. ³

The nine work functions

Version 1.4 specifies nine work functions, each with behavioural benchmarks and critical activities. ²

Document preparation

Document preparation has five benchmarks and associated critical activities. ^{4, 2, 5, 6, 7, 8}

Benchmark	Critical activities, in order
Gather, review and analyse resources or data for a high-quality document meeting internal and external customer needs.	1. Review relevant guidelines, templates and literature. 2. Obtain, compile and organise data, background and other materials. 3. Analyse and interpret them to determine the approach to composition.
Agree document architecture and content with the cross-functional team.	1. Review information and guidance with statistics, clinical development, medical and regulatory colleagues to meet company and industry requirements and clinical, nonclinical, biopharmaceutic, clinical-pharmacology and chemistry, manufacturing and controls (CMC) needs. 2. Where applicable, help plan statistical output to meet regulatory or publication requirements and clinical-development needs. 3. Agree the document’s purpose with the team and external consultants, such as support for an indication or label claim.
Author the document with cross-functional input to meet audience needs.	1. Draft from the compiled information. 2. Integrate team, expert and business-partner input. 3. Build persuasive scientific arguments serving the regulatory, publication or other purpose. 4. Advise on and compose reusable content, such as a summary used in a label.
Revise and resolve issues to deliver quality, speed and value.	1. Revise from team comments. 2. Compose the final document using reviewers’ input and other information. 3. Critically evaluate comments to maintain data consistency and document integrity. 4. Negotiate resolution of reviewer disagreements and incorporate decisions. 5. Record resolutions and the rationale for significant decisions.
Edit at the level required by document type, development stage and authoring-team request: formatting, proofreading, microediting, macroediting, rewriting or translation editing.	1. Clarify the team’s expectations and the required level of edit. 2. Edit structure, content, language and style for correctness. Editing may belong to a medical or scientific editor rather than the writer.

^{4, 2, 5, 6, 7, 8}

Document management

Document management has five benchmarks. ^{9, 10, 11, 12, 13, 14}

Benchmark	Critical activities, in order
Agree a complete work plan, tasks, subtasks, roles and responsibilities.	1. Discuss planning, data production, writing, review, editing, quality checks and publishing responsibilities in advance. 2. Coordinate tasks, people and timing. 3. Choose review-monitoring methods, such as meetings or email. 4. Choose review formats and tools, including tracked changes and explanatory comments. 5. Arrange editing, formatting, independent quality checking and publishing.
Agree a timeline that meets milestones and team objectives.	1. Draft steps, intervals, responsibilities and due dates using planning tools. 2. Obtain author and reviewer agreement.
Establish a cohesive team that delivers without delays.	1. Arrange meetings to assess progress, identify issues and monitor resolutions. 2. Maintain awareness of expectations, steps, milestones, deliverables and timeline changes. 3. Facilitate progress and consensus in meetings. 4. Work with colleagues to drive the timeline. 5. Assess and prioritise information, input and resource needs as work progresses.
Lead through conflict, disagreement and delays.	1. Monitor potential delays, problems and information gaps. 2. Negotiate, compromise, persuade and enable open discussion to resolve conflict. 3. Negotiate timeline changes where needed for a viable backup plan. 4. Seek project or functional management help when necessary.
Facilitate approval, finalisation, electronic publishing and submission as relevant to the role.	1. Ensure timely approval and readiness for publishing or submission. 2. Ensure appropriate formatting and hyperlinking. 3. Coordinate the authoring team, publishers and submission experts to meet delivery dates. 4. Ensure submissions meet regulatory-body, congress or journal requirements. 5. Arrange short- and long-term storage, archiving and retrieval. 6. Contribute to document-management-system development, implementation and maintenance. Submission and publishing may belong to a separate group.

^{9, 10, 11, 12, 13, 14}

Strategic communications within a programme team

Strategic communications has three benchmarks. ^{15, 16, 17, 18}

Benchmark	Critical activities, in order
Assess whether programmes, studies and documents deliver accurate, consistent information for the target audience.	1. Understand product strategy and how study design, data capture and statistical-analysis plans affect later documents. 2. Critique whether submission or publication strategy meets business or regulatory needs and identify missing or alternative arguments. 3. Locate intended messages across programme documents and align them. 4. Ensure study and document designs supply the information audiences need.
Align information and messages from initial strategy through study documents to programme-level deliverables, such as prescribing information or key publications.	1. Lead cross-functional messaging strategy. 2. Develop prototypes or key-message wording and align development documents with later reports, submissions, manuscripts and intended labels. 3. Manage unexpected results or data-quality issues affecting messaging. 4. Set programme standards such as style conventions. 5. Build clinical or regulatory arguments using logic, analogy and therapeutic-area science where direct data are absent. 6. Keep data and descriptions consistent across documents.
Supply document and cross-document expertise and intellectual leadership.	1. Keep electronic historical records, including regulatory rationale. 2. Align team plans with audience document requirements and suggest alternatives from experience. 3. Keep arguments sound, consistent with prior arguments and aligned with strategy and audience needs. 4. Maintain document-content history and ensure decisions, messages, issue resolutions and positioning appear consistently across programme documents.

^{15, 16, 17, 18}

Multiple-document coordination

Coordination across a submission or publication programme has two benchmarks. ^{19, 20}

Benchmark	Critical activities, in order
Agree a complete work plan with tasks, subtasks, timelines, roles and responsibilities.	1. Discuss tasks, their relationships across documents, supporting deliverables such as tables, figures, listings and literature, and author and reviewer responsibilities. 2. Apply document-preparation, document-management and strategic-communication competencies using tools and strategies for multiple documents. 3. Identify resource constraints that threaten delivery.
Lead other writers to deliver quality work on time.	1. Manage contributions to individual documents. 2. Obtain input and decisions from the appropriate people at the appropriate time. 3. Disseminate meeting information to maintain strategy and carry data or wording changes across documents, such as safety-text changes matching label updates.

^{19, 20}

Templates, standards, formats and styles

Development and maintenance of document and presentation infrastructure has three benchmarks. ^{21, 22, 23, 24}

Benchmark	Critical activities, in order
Gather, review and analyse resources for templates and standards.	1. Review current and new regulatory, publication and industry guidelines and initiatives, including regulatory websites and conference information.
Create and implement agreed templates and guidance supporting efficient, compliant authoring.	1. Create style, format and writing guides and presentation and document templates meeting regulatory, corporate and industry needs. 2. Lead review and approval with local and global stakeholder input.
Maintain guides and templates.	1. Promote adherence and maintenance with departmental, corporate, global, contract-research-organisation and alliance partners. 2. Proactively identify when guidance, standards or templates need to be created or changed.

^{21, 22, 23, 24}

Outsourcing, alliance-partner and client management

Partner management has five benchmarks. ^{25, 26, 27, 28, 29, 30}

Benchmark	Critical activities, in order
Establish governance, operational principles and tools with the partner.	1. Establish operational oversight for a document or development programme. 2. Plan communications to maintain alignment and satisfaction.
Build an effective, efficient, productive and professional relationship.	1. Decide whether to use internal or partner tools, standard operating procedures and templates. 2. Participate in bid defence, contract development, work alignment and operational meetings. 3. Build the relationship to improve communication and effectiveness. 4. Remain responsive and available for questions.
Jointly develop and implement the timeline and work plan.	1. Negotiate authorship, planning, data production, writing, review, editing, quality checks, publishing, roles and mutual expectations. 2. Agree document-flow and archiving specifications. 3. Negotiate document timelines. 4. Contribute to the work plan.
Review documents, consult relevant functions, resolve issues and oversee quality, speed and value.	1. Review partner work as needed. 2. Resolve team–partner disagreements through negotiation, compromise, persuasion and open discussion.
Establish partner-assessment tools supporting quality and a positive relationship.	1. Create feedback systems for document quality and client or vendor satisfaction. 2. Provide training and regular sharing of lessons learned.

^{25, 26, 27, 28, 29, 30}

Continuous development of knowledge and skills

Continuing development has two benchmarks. ^{31, 32, 33}

Benchmark	Critical activities, in order
Complete development activities and seek and respond to feedback benefiting company, client and career objectives.	1. Follow relevant competency maps, curricula, technical ladders and performance-management processes. 2. Assess personal technical and soft skills to identify development gaps. 3. Seek formal and informal feedback on knowledge, skills and abilities.
Pursue internal and external opportunities through classes, reading, experts, coaches, professional organisations, meetings, conferences, seminars and colleagues.	1. Maintain and develop technical knowledge, skills and abilities. 2. Continually improve non-technical knowledge, skills and abilities.

^{31, 32, 33}

Sharing knowledge and experience

Knowledge sharing should increase internal and external competence and support functional, company, client and career objectives; coaching is particularly relevant when lead writers oversee complex deliverables and review and align other writers’ documents. ³⁴ Its critical activities are the following. ³⁵

1. Anticipate colleagues’ needs, especially newcomers’, and provide formal or informal coaching, technical information, guidance, answers and appropriate contacts or resources.
2. Review documents and give meaningful feedback on form and content.
3. Mentor colleagues on soft skills, interactions and working with customers and business partners.
4. Give formal or informal feedback on performance, skills and knowledge.
5. Participate in professional-association activities.

³⁵

Process improvement

Process improvement has two benchmarks. ^{36, 37, 38, 39}

Benchmark	Critical activities, in order
Identify best practices and anticipate change to keep processes aligned with requirements.	1. Critically assess current processes, practices and technologies for greater effectiveness and efficiency. 2. Identify internal and external changes, determine necessary adjustments to processes, technology or guidance, and implement and adapt to them.
Develop, implement and communicate practices improving quality, consistency, efficiency and effectiveness.	1. Join improvement teams, committees or initiatives. 2. Introduce new processes, methods or technologies through appropriate channels. 3. Communicate improvements internally and externally to encourage consistent, widespread use.

^{36, 37, 38, 39}

Knowledge, skills and behaviours for all writers

Technical knowledge

Version 1.4 lists the following technical knowledge. ^{38, 39}

1. Scientific-writing and editing techniques.
2. Software and systems: document management, version control, electronic records and signatures, retention; word processing; spreadsheets; presentation and diagramming; databases; email and calendars; table and figure creation; Adobe Acrobat; reference management; publishing; literature searching and other internet and intranet resources; file conversion.
3. Company policies, procedures and tools, including guides, templates and project-management worksheets.
4. Other authoring-team members’ roles, including statistics, clinical research, medical, regulatory and legal functions.
5. Industry guidance: pharmaceutical regulation; professional, pharmaceutical, health and journal guidelines; trial registration and results posting; copyright and its application, publisher guidance and contracts; standards-development bodies and their standards.
6. Science: the therapeutic area, disease and compound safety and efficacy; biological sciences; CMC; biopharmaceutics; pharmacology, including pharmacokinetics and pharmacodynamics; absorption, distribution, metabolism and excretion (ADME); drug and clinical development; scientific method, hypothesis testing and clinical-research methods. Writers should be able to work across therapeutic areas with access to drug and therapy experts on their teams.
7. Descriptive and inferential statistical methods and communication of statistical results.
8. Publishing standards, including electronic publishing.
9. For training others, adult-learning concepts, instructional design and communication design.

^{38, 39}

Technical skills and abilities

The technical-skills inventory distinguishes the following activities. ⁴⁰

1. Interpret and communicate clinical and numerical data, verify consistency, perform calculations and collect data, such as chart reviews.
2. Understand and communicate scientific concepts and clinical, nonclinical, biopharmaceutic, pharmacological, ADME and CMC information.
3. Learn and communicate statistical concepts, terminology and analyses; interpret tests and significance; use appropriate terminology in text, tables and figures; simplify explanations for the audience and express statistical issues in text.
4. Author quality documents: prepare a considered structural outline; organise content within and across documents for the purpose and audience; write credible, compelling, simple, plain, clear, concise and correct text; prepare complete and accurate references; prepare contents, indexes and hyperlinks; design suitable tables and figures.
5. Conduct effective literature searches.
6. Create and lay out slides and posters.
7. Manage deliverables, including sponsorship and accountability, work and contingency plans, timelines, roles, communications, issue resolution, change control and meetings.
8. Manage scientific information flow, accuracy and consistency.
9. Edit at the required level, each level including the previous level’s tasks: format against templates and applicable guidelines; proofread for absolute errors in consistency, references, style and mechanics or compare versions and related documents; microedit at paragraph level or below for grammar, wording, flow, voice, syntax, style, logic, clarity and unnecessary duplication; macroedit at section level for content, organisation, congruency, tone, consistency, logic, completeness and audience needs.
10. Check documents against sources and verify facts, data and claims against other data.
11. Rewrite existing documents.
12. Interview for information and obtain readers’ verbal feedback through focus-group testing.
13. Report verbal presentations accurately and summarise others’ text.
14. Review content through analytical editing, critical appraisal, evaluation of statistical presentations and methods, peer review of scientific quality and completeness, and verification of regulatory requirements.
15. Translate accurately between languages, although a professional scientific translator may undertake this work; writers also need to conform to American, British or Indian English, and writers in non-English-speaking regions need English-plus-local-language communication skills.
16. Prepare publication-ready documents and visual materials, including page and web design, biomedical illustration, scientific photography and technical drawing; specialist production work may belong to a publisher, while slide and poster layout and readiness for publication remain relevant writing skills.

⁴⁰

Behavioural skills

The behavioural-skills inventory covers the following. ⁴¹

1. Organisation, time management, attention to detail and management of multiple tasks.
2. Positive, productive relationships and effective decisions.
3. Learning agility: becoming effective on new projects quickly.
4. Negotiation, conflict resolution and adaptation to change.
5. Creating solutions, influencing adoption, leadership and teamwork.
6. A focus on results and performance with proactive action.
7. Commercial judgement and ethical conduct, including copyright, authorship and acknowledgements, avoidance of plagiarism and falsification, and patients’ and subjects’ best interests.
8. Work sharing across global teams.
9. Cultural sensitivity and productive multicultural teamwork.

⁴¹

Additional regulatory-writing competencies

The regulatory knowledge specified in version 1.4 includes the following. ⁴²

1. Relevant ICH guidance and regional interpretations, including CTD guidance (ICH M4); labelling guidance, including Structured Product Labeling and the Physician Labeling Rule; interactions with prescribing physicians; electronic-submission guidance, including Regulated Product Submission and Study Tagging Files; and regional US, EU and Japanese guidance and important differences in document and submission requirements elsewhere.
2. Regulatory-authority and global initiatives.
3. Clinical, nonclinical and CMC requirements supporting major filings.
4. Standardisation initiatives, including CDISC and CDASH.

⁴²

Its additional skills are the following. ⁴³

1. Prepare a project communication strategy, such as a submission key-message map or publication plan.

2. Author regulatory documents, including:

   • Advisory-committee materials.
   • Annual safety reports, development safety update reports and periodic safety update reports.
   • Annual IND and NDA reports.
   • Bioanalytical reports where relevant, often written by a scientist.
   • Briefing documents.
   • Clinical-development plans.
   • Phase I–IV clinical study reports, including clinical-pharmacology reports.
   • Trial applications and notifications.
   • Registry results.
   • CTD modules 1–5, including FDA integrated safety and efficacy summaries, overviews and summaries.
   • Country-specific documents and responses.
   • Investigator brochures.
   • Investigational-device exemptions.
   • Investigational medicinal product dossiers.
   • Investigational new drug applications.
   • Labels, supplements and EU variations.
   • New drug applications, marketing-authorisation applications, new drug submissions and supplements.
   • Non-eCTD and other modified electronic submissions and documents for countries not accepting CTD.
   • Nonclinical reports.
   • Paediatric investigation plans.
   • Periodic safety update reports.
   • Premarket-approval applications.
   • Premarket notifications.
   • Phase I–IV clinical-pharmacology, clinical-trial and observational protocols, amendments and addenda.
   • Regulatory responses.
   • Submissions in non-CTD countries.
   • Risk-management plans and risk-evaluation and mitigation strategies.
   • Risk profiles.
   • Safety narratives.
   • Safety updates.
   • White papers.

3. Prepare documents suitable and ready for electronic publishing.

⁴³

Additional publication-writing competencies

The publication knowledge specified in version 1.4 includes the following. ⁴⁴

1. Publication guidance: Good Publication Practice for Pharmaceutical Companies, Uniform Requirements for Manuscripts Submitted to Biomedical Journals, medical-writing organisations’ position statements, and interactions with prescribing physicians and investigator-authors.
2. Publication planning and coordination, including planning systems and software.
3. Reporting guidance: CONSORT for randomised trials, its abstracts and harms extensions; STARD for diagnostic accuracy; PRISMA and its predecessor QUOROM for systematic reviews and meta-analyses; MOOSE for meta-analyses of observational studies; STROBE for observational studies.

⁴⁴

The additional skills are the following. ⁴⁵

1. Prepare, implement and track a publication strategy specifying what will be published, where, when and why; a specialist planner may undertake planning, but it remains a general publication-writing skill.
2. Author peer-reviewed manuscripts, narrative or systematic reviews, conference abstracts, posters, slide presentations, responses to reviewers, conference reports, journal-article summaries and publication-ready tables and figures.
3. Prepare documents meeting journal requirements.

⁴⁵

The 2017 revision

The model was revised in 2017 by a team with 419 cumulative years of medical-writing experience across sectors, companies and regions. ⁴⁶ Its sections cover knowledge, skills, abilities and behaviours (KSABs), work functions and additional information such as general abilities and certifications, with common requirements and niche-specific additions. ⁴⁶ The revised model’s summary distinguishes three groups. ⁴⁷

Group	Knowledge and skills	Abilities	Behaviours
All medical writers	Industry guidance, project management, science and communication techniques.	Deliver written and visual scientific narratives; author content for cascade-level messaging.	Highest ethical standards and judgement-based thinking.
Regulatory writers	Standardisation initiatives such as ICH; regulatory-authority regulations and guidance.	Prepare submission communication strategies and documents for electronic publishing.	—
Publication writers	Publication guidance such as GPP3; reporting guidance such as CONSORT.	Prepare publication-plan strategies and publication documents.	—

⁴⁷