Main Responsibilities and Required Skills for Medical Writer
A Medical Writer is a professional who is responsible for writing and reviwing written materials related to the medical field, such as scientific papers, patient education materials, and regulatory documents. They may work for pharmaceutical companies, medical communications agencies, or other organizations involved in the healthcare industry. In this blog post we describe the primary responsibilities and the most in-demand hard and soft skills for Medical Writers.
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Main Responsibilities of Medical Writer
The following list describes the typical responsibilities of a Medical Writer:
Advise
Advise clients and other Units in methodological and scientific aspects of studies.
Analyze
Analyze results in preparation for product applications and submissions.
Analyze, interpret, and distill data and other information to create documents.
Apply
Apply principles of good publication practice at all times.
Assist
Assist in coordination of team workload.
Assist in establishing processes to ensure the quality of project deliverables.
Assist in presenting information at internal or external meetings.
Assist in the composition and review of validation protocols and reports.
Assist in the development of SOPs and work practices.
Assist with the conduct of structured and / or systematic reviews of clinical literature.
Attend
Attend internal and external team meetings.
Build
Build and sustain rapport with clinical personnel, including internal clients and colleagues.
Challenge
Challenge conclusions when necessary.
Coach
Coach and support Medical Writers.
Coach, mentor, and assist medical writers.
Collaborate with
Collaborate with project teams to respond to health authority questions and requests.
Compile
Compile study documents, as required.
Complete
Complete required administrated tasks within the specified timeframes.
Complete sections of proposal without support and able to present / pitch those sections.
Conduct
Conduct all work in compliance with SOP's, GCP and to observe all regulatory guidelines.
Confirm
Confirm accurate classification of events and medications using standardized coding systems.
Confirm completeness of info to be presented.
Contribute
Contribute to generation of proposals.
Contribute to Pre-Submissions, Design and Value dossiers for matrix submissions.
Contribute to risk assessment and management plans (RAMPs) for assigned studies.
Contribute to the development of asset- or therapeutic area-level conventions.
Contribute to the development of conference coverage reports for internal distribution.
Contribute to the intellectual design, planning and organisation of projects.
Coordinate
Coordinate activities with product development teams to ensure goals are met.
Coordinate documents prepared by other writers as needed.
Coordinate medical writing activities in study teams, including external services.
Create
Create and execute regulatory strategies.
Create, maintain and assume accountability for a culture of high customer service.
Create or manages timelines of deliverables.
Create procedure documents based on content and specifications provided by subject matter experts.
Defend
Defend creative work to support client initiatives during regulatory processes and legal review.
Deliver
Deliver documented quality review comments / checklist to document author through resolution.
Develop
Develop and maintain document timelines in line with business objectives.
Develop and maintain project timelines.
Develop an understanding of the various client brand and disease areas.
Develop clinical protocols for clinical studies of any complexity.
Develop good working relationships with internal and external colleagues.
Develop insightful and meaningful written and / or oral critical analysis of regulatory issues.
Develop strategic content.
Digest
Digest scientific material and understand client regulatory / FDA / PAAB guidelines.
Draft
Draft article summaries for distribution to key stakeholders.
Drive
Drive document preparation process within teams.
Drive decision making about data presentation strategies to support advance planning of documents.
Drive the QC of clinical regulatory documents to timely completion.
Engage
Engage in continuous learning.
Ensure
Ensure all electronic document deliverables are processed and completed in alignment with timelines.
Ensure highest scientific standards and clinical accuracy across projects and teams.
Ensure information sharing among MWs.
Ensure on-time delivery of high-quality documentation that is compliant with the Quality System.
Ensure quality by following procedures, work instructions and templates.
Ensure regular and proactive communication among department staff.
Ensure that quality control is paramount within all materials produced across the business.
Establish
Establish style guides, templates, and best practice guidelines as needed.
Explain
Explain data in manner consistent with clinical regulatory requirements.
Explain the data in a manner consistent with the target audience and regulatory requirements.
Facilitate
Facilitate the creation of reports and other client deliverables.
Finalize
Finalize documents for delivery to sponsors according to the established timelines.
Formulate
Formulate writing approach, develops timelines, and assesses resource requirements.
Foster
Foster a collaborative working environment among all team members and departments.
Generate
Generate effective healthcare headlines and copy.
Guide
Guide or contribute to process improvement initiatives.
Handle
Handle and verify translations prepared by Translation Agencies.
Hold
Hold team members accountable to agreed-upon project dates and with an appropriate quality level.
Identify
Identify and analyze clinical / regulatory information to support a variety of projects.
Identify, communicate, and resolve issues impacting document timelines.
Identify ways to improve the efficiency and quality of work processes.
Impart
Impart / conduct Trainings for peers and team members.
Implement
Implement tactical process improvements.
Incorporate
Incorporate internal and / or external review comments on clinical documentation.
Incorporate text, graphs, charts, tables, statistical analyses, etc. in a clear and accurate manner.
Influence
Influence other department staff to accept and embrace new working practices.
Influence teams to adhere to the relevant medical writing requirements for projects.
Interact with
Interact with clients to understand their objectives and meet their needs.
Interpret
Interpret and explains data generated from a variety of sources.
Interpret data and verify that results are consistent with protocols.
Interpret statistical study results and describes them appropriately in reports.
Lead
Lead comment resolution team meetings for assigned documents.
Lead dossier preparation and writes key documents and / or oversees the writing of others.
Lead or contribute to process improvement initiatives.
Lead project management and coordination of narrative projects.
Learn
Learn to interpret data and apply knowledge of regulatory / compliance / scientific.
Maintain
Maintain a professional attitude, even in challenging situations.
Maintain awareness of overall project timelines and deliverables.
Maintain consistency across clinical documentation.
Maintain copy quality control throughout all aspects of the production process.
Maintain familiarity with client expectations and produce documents consistent with these.
Maintain regular and punctual attendance.
Maintain strict timelines for technical, clinical / nonclinical documents.
Manage
Manage Departmental document archiving process.
Manage editorial processes and SOPs.
Manage multiple projects concurrently.
Manage the Global Outcomes Team, while still working as an active writer on the team.
Manage writing activities to complete documents within agreed-upon timelines.
Mentor
Mentor Associate Medical Writers and Medical Writer I, as appropriate.
Monitor
Monitor and report on project progress for the assigned writing projects.
Operate
Operate as a team or independently while maintaining flexibility and resilience.
Oversee
Oversee all publications and presentations for the Virology TA.
Oversee and coordinate other writers on CSR appendices compilation and narrative projects.
Oversee or contribute to process improvement initiatives.
Oversee submission process for copy approval team meetings.
Participate in
Participate in departmental or interdepartmental quality improvement initiatives.
Participate in market research.
Participate in new business pitches and other agency initiatives.
Participate in process improvement activities.
Participate in proposal preparations.
Participate in the periodic.
Perform
Perform literature reviews in support of medical writing efforts.
Perform literature searches.
Perform literature searches as needed for drafting document content.
Perform on-line clinical literature searches, as applicable.
Perform proofreading and quality assurance tasks.
Perform / review Signal detection activities.
Populate
Populate and update website content using a content management system (CMS).
Prepare
Prepare and review patient safety narratives.
Prepare documents in accordance with internal standards and external regulatory guidelines.
Prepare literature for new products, and revises existing literature.
Prepare medical information responses for HCPs.
Prepare responses and justifications to CTA clarifaxes, ERB inquiries and Sponsor queries.
Prepare selected components of regulatory clinical documentation.
Produce
Produce documents in conjunction with external vendors.
Produce high-quality and timely documentation in line with expectations.
Produce research and written deliverables to a high standard.
Proof
Proof all material to ensure compliance and regulatory requirements are upheld.
Provide
Provide feedback on SAP and TFLs to project team as needed.
Provide feedback to further define statistical output required.
Provide feedback to their managers on development plans and performance reviews.
Provide guidance for medical writing processes, standards, and initiatives.
Provide input and feedback to management regarding internal medical writers' work product / quality.
Provide insights into new therapy areas quickly and confidently.
Provide leadership for medical writing processes, standards, and innovative initiatives.
Provide project oversight and ensure that projects stay within budget parameters.
Provide scientific counsel and expertise to the wider HU team as the content lead.
Provide strategic and operational leadership to direct preparation and completion of documents.
Recommend
Recommend obtaining CMPP certification from ISMPP.
Represent
Represent Covance at scientific and medical writing forums.
Represent department in audits and inter-department working groups.
Represent functional area in cross-functional team (either internally or externally).
Research
Research and assess the appropriateness of various health outcome measures.
Respond to
Respond to escalations and interact with our contact center Team.
Review
Review and provide assistance in answering deficiency letters from regulatory agencies, as required.
Review and provide assistance on answering deficiency letters from regulatory agencies, as required.
Review and provide feedback on client-provided protocols, as required.
Review, circulates, edits, assembles, inspects, and duplicates product submissions.
Review clinical development plans to ensure adequate planning of medical writing activities.
Review of Statistical Analysis Plans.
Share
Share experience with and train other medical writers.
Stay current with
Stay current with regulatory requirements and initiate process improvements as appropriate.
Suggest
Suggest changes to document processes or templates to improve quality and / or efficiency.
Supervise
Supervise in-house training of medical writers (primarily through editing of written material).
Supervise the Associate Director of publications for the Virology TA.
Supervise the work of vendors contracted to produce meeting materials.
Support
Support additional clinical, regulatory, quality and engineering related deliverable as assigned.
Support and helps draft publications arising from clinical studies.
Support compilation of Annual Product Quality Reviews.
Support other projects associated with Medical Writing / Regulatory Affairs.
Support project teams by providing analyses of clinical data.
Support training of Medical Writers and Medical Writing Associates.
Track
Track progress and provide updates to stakeholders for assigned projects.
Track QRs and ensures deadlines are met.
Understand
Understand marketing and creative strategies for assigned brands.
Understand relationships and dependencies between documents and analyses produced for regulators.
Understand sources of information.
Undertake
Undertake be-spoke research and data collection as required.
Undertake bespoke research and data collection as required.
Undertake or direct research into therapy areas, as needed.
Undertake various projects and tasks as assigned.
Use
Use ADD (Abbott Diagnostics Division) manufacturing / testing documentation systems.
Verify
Verify that results are consistent with protocols.
Work with
Work closely with the Regulatory team(s) on document strategies.
Work collaboratively with colleagues across functions to achieve results.
Work effectively on cross-functional teams.
Work in a collaborative team setting.
Work in a cross-functional team and draft clinical study reports (CSRs).
Write
Write and edit plain language materials on a variety of COVID-19 and HIV-related topics.
Write and maintain files on informative journal abstracts according to current or estimated future.
Write and review abstracts / posters.
Write and review Clinical Study Protocols / Clinical Investigation Plans and Subject Information.
Write and review Investigational Medicinal Product Dossiers.
Write and review publications.
Write coherent and engaging procedural content for a medical diagnostic device.
Write engaging clinical, nonclinical, and healthcare lifestyle content, as assigned.
Write or oversee writing of study-specific clinical protocols and reports.
Write subject narratives for adverse drug reactions and serious adverse events.
Most In-demand Hard Skills
Medical Writing
Microsoft Office
Life Sciences
Adobe Acrobat
Pharmaceutical
EDIting
Writing
Healthcare
Valid Driving License
International Governmental Regulations
Pharmd
Present Clinical Data Objectively
Keeping With Industry Guidelines
Document Management Systems
Literature Reviews
Scientific
Biotech Industry
Advancing Science
Clinical Regulatory Documents
Most In-demand Soft Skills
The following list describes the most required soft skills of a Medical Writer:
Written and oral communication skills
Attention to detail
Organizational capacity
Interpersonal skills
Presentation
Multi-task
Accurate
Problem-solving attitude
Get involved and show initiative
Time-management
Collaborative partners
Take the initiative to lead projects and assignments
Think analytically
Work and make independent decisions
High emotional intelligence
Leadership
Build strong working relationships
Confident
Acquire and apply knowledge quickly
Analytical ability
