Setting up an in-house writing function
An in-house writing function needs a defined role within its organisation, suitable staffing and funding, and processes for working with other teams. Shared standards and accessible departmental information support consistency as the function develops.
Establishing a new function
A new writing function should be shaped around the organisation's specific needs, with an internal champion who understands what medical writing can contribute. Early effort should concentrate on pressing priorities, with competence in completing projects, commitment to team goals and a customer-service orientation helping the department contribute to organisational success.
In a 2010 clinical-stage company, a new medical-writing function coordinated staff and contract writers assigned to programmes and projects, producing clinical study reports, investigator's brochures, protocols, clinical data summaries, manuscripts and presentations. Establishing the function included finding ways to work with existing teams and creating processes and standards for consistency and efficiency across programmes.
Merck's central medical-writing function, described in 2016, combined professional writers and operations staff to provide end-to-end support for its clinical development pipeline. Its first-year challenge was to make the organisational change while continuing to deliver hundreds of protocols and clinical study reports, thousands of patient narratives and multiple regulatory filings. The company identified strategic planning, dedicated and highly experienced leadership, extensive stakeholder engagement and corporate support as essential to the launch.
Established department structures
A survey in November–December 2009 included 15 directors and managers from 13 pharmaceutical and biotechnology companies, all among the industry's 50 largest and 62% among its 20 largest. Company headquarters were in the US (61%), Europe (31%) and Japan (8%), and the reported company-type mix was 87% pharmaceutical and 13% biotechnology. Seven respondents had responsibility for regulatory submissions, five for scientific communications and three for both.
The survey reported separate departments in 80% of cases, with regulatory writing and scientific publication functions always separate from each other; its detailed results described the medical-communication functions as distinct organisational structures in every participating company. Responsibility for particular document types could nevertheless be shared with other functions. Sole or shared responsibilities included educational materials, health technology assessment dossiers, peer-reviewed publications, presentations, posters, book chapters and regulatory documents, but none of the respondents had responsibility for competitive intelligence, market research, marketing materials or public relations. For half, regulatory documentation occupied 90–100% of departmental time.
The median group had 19 full-time employees, with 10th and 90th percentiles of nine and 45, and most departments relied mainly on full-time on-site employees supplemented by relatively few contractors and part-time staff. Although 73% reported growth over the preceding three years, only 47% expected growth over the next three, with most others expecting no change.
Respondents collaborated with clinical development (93%), pharmacovigilance and regulatory operations (87% each), clinical operations and preclinical research (73% each), marketing (60%), legal (53%), pricing or health outcomes (40%), manufacturing (33%) and public relations (20%). Extensive collaboration and review occurred for every document type, suggesting partnerships in which scientists and communicators contributed different expertise.
An institutional editing service
Texas Heart Institute's Section of Scientific Publications provided writing, editing and publication support for roughly 200 clinicians and scientists in 2015. It grew from a research coordinator's role beginning in 1976 as researchers produced results faster than they could write them up; a second editor was hired in 1981 and a third in 1989, when the section was formed. By 2015 it comprised six manuscript editor-writers, a grant editor-writer and an editorial assistant, with two editors working remotely, one in Dallas and one in Germany.
Salaries and expenses came from the institute's general operating fund, and services were free to professional staff and residents, fellows and others working with them on manuscripts. The institute's leadership intended this to attract research-oriented physicians and scientists, while dispensing with billing also saved time and costs associated with tracking billable hours, invoicing and payments.
The same staff wrote and edited academic materials, including journal articles, books, chapters, monographs, conference abstracts, posters, slide sets and grant proposals, with editing forming most of the work. Authors could work with the service by email, telephone or in person; standard-length manuscripts were normally returned within two weeks and the shortest projects, mainly abstracts, within 24 hours. Publication support included journal formatting, cover letters, submission, tracking review, revised manuscripts and response letters, galley proofs, reproduction permissions and communication with journals and publishers. The editorial assistant handled many of those tasks so editors could focus on editing.
The departmental handbook
A medical-writing handbook can provide one source of day-to-day departmental information, whether the group is large and global or small and reliant on vendors. Ideally indexed for one-click access, it brings together policies, processes, tools, templates and checklists, helping staff find current information and maintain consistent practices and style while easing employee and contractor onboarding. Its length and contents should fit the department's activities, and a shared location permits frequent access and editing as new and established processes evolve.
Core contents include the organisational structure and key contacts, possibly with photographs, followed by departmental functions, project types and connections with other departments. Training resources can cover standard operating procedures and soft skills, alongside explanations of document-management, IT and library or literature systems. Writing-specific processes can include deliverable development and review, recommended timelines and sample review-notification emails; corporate processes unrelated to writing should point to the organisation's official information to maintain consistency.
Further resources can include writing tools, templates, regulatory guidance, subject-matter experts, sample documents, checklists, a style guide and useful hyperlinks. Performance and career development, regional information and contractor invoicing or financial information are optional additions. General information may be preferable where nonessential detail would require frequent updates, and each hyperlink should have a short description so the handbook can direct users without relying on the linked document. Redundancy within the handbook and unnecessary duplication of linked documents should be avoided, while bold type and highlighting may help comprehension.
Review should proceed through three groups:
- Content owners verify accuracy, including updates to procedures and templates.
- Medical-writing management, including regional management where relevant, adds a broader perspective and fills gaps.
- Employees and contractors provide end-user feedback and check internal links.
A standing invitation for contributions and feedback helps maintain the handbook, and reminders should accompany its release and additions. Sole ownership provides control, consistency and continuity but can burden one person and slow updates; group ownership shares work but takes more coordination, while rotating ownership can combine perspectives, especially across regions.
The handbook can be a web page rather than a paginated document and can begin short and simple before expanding with departmental needs. A sample web layout used sections for writing tools, people, training, checklists, forms and other resources. Its entries included templates, an organisation chart, ICH guidance, regional contacts, new-hire, therapeutic-area, project-management, PowerPoint and soft-skills training, a style guide, sample documents and timelines, writer tips, resourcing, publishing, onboarding and quality-control checklists, subject-matter experts, frequently used procedures, quality-control turnaround estimates, a finalisation checklist, quality-control request forms, holiday and document-approval forms and the company holiday schedule. The initial investment can improve efficiency across the department through subsequent use.