This position will lead scientific, medical and regulatory writing activities for all development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs). The professional will also perform the review, edit, and writing of documents and be responsible for the management, planning and direction of a team of medical writers. The professional will provide mentoring and career development to the medical writing team; will ensure the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and supported by appropriate data. This job contributes to and supports the company s research and development efforts to create high value therapeutics to address unmet medical needs.
Manages all clinical writing activities outlined in the Project Clinical Development Plans. Reviews documents, offers guidance, and takes lead in mentoring writers in the preparation of regulatory and publication documents. Organizes, conducts, and leads document production meetings and other meetings as necessary. Projects Medical Writing budget, resource, and timeline requirements for CDP. Responsible for timeline management, budget and managing outside vendors on regulatory document writing projects. Responsible for developing and managing Departmental Guidelines management system, Writing style guide and departmental templates such as, protocols, investigators brochures, final clinical study reports, IND sections. Provides and manages internal and external writing activities. Responsible for developing department infrastructure such as establishing style guides, and generation of templates and processes. Manages internal staffing and performance management, including hiring, training, coaching and performance reviews.
A Bachelors/Masters degree in a scientific discipline with a strong journalism background is required. Equivalent experience may be accepted. PhD. in a scientific or life sciences discipline preferred. Demonstrated experience as a primary author writing regulated scientific documents. Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents. Knowledge of CTD format. Ability to produce Protocols, Clinical Study Reports, Informed consent forms and Full ICH reports. Strong analytical and strategic thinking skills with the ability to implement. A minimum of 13 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 8 years writing management experience is also required. A minimum of 10 years previous supervisory experience is required. An ability to create effective presentations from raw data is essential. An ability to interpret statistical and clinical data is essential. Must have an ability to work well with others in high-pressure situations. Must have demonstrated problem solving abilities. Strong organizational skills are required. Strong written and verbal communication skills are required. An understanding of clinical research, biostatistics, and regulatory affairs is required. Must have experience writing clinical protocols, clinical study reports, and IND/NDA sections. Good computer skills are required. Working knowledge of MS word, Excel, Power point is required.