Large Complex Freelance Medical Writing Projects Best Practices
Large, Complex Freelance Medical Writing Projects: Best Practices Debby Berlyne, Freelance Medical Writer And Editor Tom Drake, Director, Global Outcomes Group
Workshop Agenda • Introductions • Workshop Overview and Objectives • Case Study Reviews and Analysis • Review Best Practices • Questions and Answers
About Debby and Tom • Debby: Freelance medical writer/editor for 20 years • Experience in cancer, hematology, mental health, nutrition, pediatrics, gerontology, health disparities • Expertise in journal manuscripts, white papers, meeting and ad board summaries, and translating technical material into lay language • Tom: Medical communications veteran with 30+ years of experience in bio/pharma industry and medical communications agency
What Is Driving This Trend in Medical Writing? Expansion of large written deliverables in bio-pharmaceutical industry Increasing reliance on experienced freelance writers for companies lacking these resources Improved internet connectivity to support use of freelancers nationally and globally Downsizing of bio/pharma medical affairs and medical writing staff
Definition: Complex Freelance Medical Writing Projects • More than 2 freelance writers • 1 primary editor and potentially other editors • At least one other team member (eg, proofreader, project manager, graphic designer) • Involves research, writing, editing, layout/formatting
Definition: Complex Freelance Medical Writing Projects (Con’t) • Deliverable: 100 + pages • Timeframe: Takes at least 3 months to complete • Multiple sections requiring different medical writing skills requiring experience with at least one of: • Relevant disease, therapy, drug, or device writing experience • Real-world evidence and/or health economics outcomes research • Health technology assessment
Complex Project Examples • Academy of Managed Care Pharmacy (AMCP) dossier for agents with multiple clinical indications • Global value dossier (GVD) • Health technology assessment (HTA) • Publication plans where product has multiple indications • Master slide decks (from major study report or conference coverage event)
Discussions and Negotiations with Hiring Agency • Previous work with the agency or company • Completion of a similar project of this scale using freelance support as successful example • Clear parameters for participation • Scope of writing support: hours, pages, word count, payment schedule • Clear delivery schedule • First draft, subsequent drafts
Building Team of Qualified Freelance Talent 1 Determine types of freelance skills needed 2 Determine number of freelancers needed 3 Suggest additional freelancers with needed skills
Delivery Team Configuration • Team lead • Project manager • Lead writer • Support writers • Editors • Graphic support • Client liaison
Key Roles • Team lead: • Identifies and hires freelancers • Manages budget and payments • Communicates with client • Assigns tasks • Oversees project timelines
Key Roles (Cont’d) • Project manager: • Can have additional responsibilities on team (eg, writing or editing) • Assigns tasks to team members • Monitors progress and communicates with team lead • Finds needed resources (and organizes them with or without team lead) • Troubleshoots
Key Roles (Cont’d) • Lead writer: • • • Responsible for document consistency and quality Creates document templates Answers content-related questions Reviews work of other freelance writers Manages version control • Other freelance writers • Conduct research • Produce initial drafts • Revise drafts
Key Roles (Cont’d) Optional: • Editor/proofreader • Graphic designer • Statistician • Subject matter expert • Web designer or digital programmer
Managing Client Expectations • Work with team lead and project manager to encourage open and frequent communication within delivery team • Kickoff meeting for client and team • Helps with downstream communication • Encourage regular team teleconferences with client at specific milestones
Managing Internal Deadlines Internal deadlines • Keep internal lines of communication open and communicate project status frequently • Coordinate internal team teleconferences and identify issues that could cause delays: • Vacation schedules • Illness • Other project work
Managing External (Client-Driven) Deadlines External deadlines • New product launch or new product indication • Hard deadline for deliverable • Conference or meeting with external stakeholders • Internal meeting with senior management Work to complete project on time • Communicate with client – create and agree on deliverable timeline • Request timely delivery of background and support materials
Basics for Effective Team Delivery • Up-to-date computer and internet connectivity • Compatible software • Agreed-on document management system • Drop. Box, Google Drive, Share. Point • File naming protocols • End. Note
Managing Communications Copy team leader and project manager on all emails Periodic (regularly scheduled? ) team teleconferences Group emails with status updates from team leader and project manager
Example of Client Communication 1 Hi all, Please find attached the review and revisions required for section 1 of the dossier. Please send this revision to me by EOB Thursday 10/22. Make all the revisions described in this document. If you do not make any of these revisions for any reason, let me know before sending me the updated version. Many or all of the comments in this document are very clear and directive, so they should be easy to follow. Please let me know if you have any questions or cannot meet this deadline. Kind regards, Client
Example of Client Communication 2 Hi Tom, Thanks for the follow up. We need the final version of the dossier by EOB today because we communicated this date to our internal stakeholders. We need to start addressing our customers’ inquiries today. Therefore, can you please make it a priority to ask us any outstanding questions? These questions must not delay the completion of the deliverable. Kind regards, Client
Case Study 1: Version Control Process: • Writer prepares draft 1, submits draft 1 to graphic designer • Graphic designer formats the document and prepares graphics, submits to editor • Editor reviews document and sends it back to writer to finalize But sometimes, things don’t work that way!
Case Study 1: Version Control (Con’t) What can go wrong: • Online version not up to date • Team member mistakenly sends outdated version • Two team members work on two versions • Older version is submitted to client
Case Study 1: Version Control (Con’t) • File name rules • Initials of last person to make changes, date, time • Single keeper of each file • Single shared online folder for latest versions • Subfolders for older versions • Use online document management tools (e. g. , Share. Point, Google Docs)
Case Study 2: Too Many Source Documents • 100 s of PDFs hard to find in shared folders • Different naming conventions used • Alphabetical listing not always informative • Many different folders and subfolders—where to look? • Same file with different names in different folders (or even the same folder!)
Case Study 2: Too Many Source Documents (Con’t) • Single manager of folders (project manager, lead writer) • Single, logical nomenclature system for folders • Single nomenclature system for file names
Case Study 3: Freelancer Not Meeting Deadline • One person falls 2 days behind and… • The freelance graphic designer won’t be available any more • The editor won’t be available any more • 2 days late becomes 1 week late
Case Study 3: Freelancer Not Meeting Deadline (Con’t) • Find out reason for holdup • Brainstorm potential solutions with freelancer • Find another freelancer to help • Technology • Alter the deadline • Give the assignment to someone else
Case Study 4: Poor-quality Work • Seemingly well-qualified company • Offers low-cost services • Completes work early • But…the work quality is poor
Case Study 4: Poor-quality Work (Con’t) Tom, Please see the email below sent by Shirley on October 1 st and then again on December 1 st. Please review your emails more carefully as we do not want things like this to delay the turnaround of the dossier, especially because the information was provided to you in previous communications. Kind regards, Client
Case Study 4: Poor-quality Work (Con’t) • Can the freelancer do it well? • If so, redo • Pay for the redo? • If not, find another freelancer • Pay for original poor work? • Best approach: Prevention! • Ask new freelancers to do short, small task first • Pay for this work
Case Study 5: New Client Contact Person Original client moves on and a new client takes over • Team lead needs to talk to new client • Provide history of project and status report • Internal team meeting to review changes • Scope of deliverable • Completion timeline • Expectations
Summary: Do’s 1 • Schedule internal kickoff meetings with team members • Schedule separate kickoff call with client and all team members • Record call for future review • • • Appoint a project manager and lead writer Assign ≤ 1 writer to each section Keep all team members up to date on project status Track status of all project elements Verify abilities of all freelancers Use multiple reviews of all work
Summary: Do’s 2 • Track status of all project elements • Verify abilities of all freelancers • Use multiple reviews of all work • Have backups for each team member • Make contingency plans for potential problems • Negotiate reasonable deadlines with client • Keep client informed of unexpected issues
Don’ts Let client communication lapse Let delays escalate Submit sloppy work to meet deadlines Deliver sub-par work early or on time if excellent work can be delivered a bit later • Admit problems to client • Forget to ongoing communication with all internal team members • •
Thank You Debby Berlyne, Ph. D djberlyne@gmail. com Tom Drake, MA, CMPP tom@globaloutcomesgroup. com
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