Medical writers are an integral part of the pharmaceutical industry. Successful medical writers possess various key competencies such as flawless English language skills, flair for writing, ability to present medical data accurately, audience identification, commitment to quality, team skills, ability to meet deadlines etc.
Pharmaceutical industry, Contract Research Organisations (CRO’s) and communications agencies frequently hire medical writers in full time positions. They can also work as freelance medical writers and medical journalists. The nature of work of a medical writer varies from company to company. Those working with CRO’s and pharmaceutical companies are mainly involved with regulatory document preparation, while those who work with communication agencies are involved in preparing promotional and marketing related documents. Medical writers are involved in preparation of scientific documentation at all levels of drug development, and for this pharmaceutical companies have separate and well organized medical writing departments. Medical writers are also involved in consultancy services, for providing information on document templates, regulatory requirements, protocol information, branding & styling for the product, quality control, and presentation & marketing of the product. Medical writers in senior positions are often involved in handling additional responsibilities such as providing input in drug development programmes, trial designs, data analysis, product launch and marketing strategies.
Clarity, document quality, marketing messages and scientific argument construction should reflect in the writings of medical writers. It is important for medical writers to have an effective level of interaction with the team members, external consultants, clients, and investigators.
Medical writers often handle multiple job responsibilities within a given project and are often provided backup support by designated team members. Experienced medical writers with vast knowledge are often referred to as encyclopaedic figures for medical writing, “jack of all trades” and the masters of communication.
Good team skills are an important prerequisite for medical writers. Medical writers who work in isolation, avoid in-person meetings and telephonic conversations with other team members, find their professional life more difficult. Good team skills can be developed through appropriate training and encouraging team activities and interaction. Professional training’s also prove helpful.
During a project there are often conflicts among different stakeholders which must be minimised. Medical writers must maintain necessary communication among these stakeholders to ensure the consistent delivery of the final product. In case of short project deadlines an open discussion might prove fruitful. Maintaining scientific rigor along with an open discussion often helps in resolving most conflicts.
A team should be able to identify the basic hindrances and plan crossroads accordingly. In order to avoid any delays in the project, team conflict and over work pressure on the team, it is important for the medical writer to assign study reports to be drafted, effectively in the team. In parallel with the project leader, medical writer is responsible for providing inputs into the documents and holding regular meetings to resolve the issues. In case of varied opinions, in person meetings should be avoided and the issue should be discussed openly with all the team members.
Common Problems With The Medical Writing Profession:
Stressful work conditions, feeling of isolation and unappreciation are common problems with the medical writing profession. These feelings tend to increase in small medical writing departments with inadequate line management. Effective management proves helpful in such cases. Clearly defining employee job responsibilities and including the list of core skills are important so that employees clearly understand what is expected from them. Regular training sessions are motivating and help the medical writers to learn new and polish existing skills. Regular appraisals and professional mentoring are important to keep the morale high. Administrative support along with clear line management should be available. Considering medical writers as experienced professionals contributing at all the levels of the project, enhances the profile of the medical writing department. Managers are also required to act as internal advocates in resolving any conflicts between the team. Team motivation and team building can be achieved by assigning new challenges and work variety along with fair work distribution among the team members. The main objective of any employer should revolve around the effective training, maintaining, developing and retaining its medical writers.
Other practical skills that prove to be beneficial for the medical writer are computing, proofreading and editing. Importance of effective proofreading and editing skills cannot be ignored in new medical writers. Proofreading and editing are often considered as a brief revision to find errors made by non-medical writers, but for professional medical writers they have different meanings. Professional medical writers define proofreading as a comparison between two versions of the same document (e.g. a word copy and a typeset copy) or within the document itself to find errors and inconsistencies. Editing is correcting and improving the document for readability, following a specific editorial style and preparing the document for next step of the process. Clear review of processes used for drafting documents, use of style sheets/checklists, and establishing standard operating procedures help ensure quality and consistency of the document.
To conclude, medical writers play an important role throughout the drug development process as well as after the product launch. Experienced medical writers with the knowledge of different therapeutic indications and drugs, understanding of all stages of drug development, thorough understanding of launch and marketing of the product, ability of effective decision making and an edge to quality; add to their value for the company. Use of practical skills, team skills, effective management, and appropriate training together contribute towards the success of medical writers.