Summary
This position will report to the Medical Writing Department Head and will lead scientific, medical and regulatory writing activities for 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 medical writing, QC reviews, and editing of the documents and will be responsible for the management, planning and direction of a team of medical writers. The professional 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 medical needs.
Essential Duties and Responsibilities
- Manages all clinical writing activities outlined in the Project Clinical Development Plans
- Reviews documents, offers guidance, and takes lead in creating and managing the document timelines in the preparation of regulatory and publication documents
- Organizes, conducts, and leads document production meetings and other meetings as necessary. Creates the agendas and minutes to document meetings according to SOPs
- Manages the oversight of CT.gov updates and when required enters CT.gov updates directly into the system including data entry when necessary
- Projects Medical Writing assignments, resource allocation, and timeline requirements for CDP
- Responsible for implementing the departmental guidelines, writing style guide and departmental templates such as protocols, investigator's brochures, final clinical study reports, and IND sections
Remote work, must be available PST time zone but offsite location is flexible.
Education
A Bachelors/Masters degree in a scientific discipline with a strong medical writing background is required. PhD. in a scientific or life sciences discipline preferred.
Skills
- A minimum of 10 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.
- Demonstrated experience as a primary author writing protocols, IBs, CSRs, IND/NDA sections and other regulated documents.
- Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents.
- Knowledge of CTD format.
- Strong analytical and strategic thinking skills with the ability to implement.
- 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.
- Experience managing CT.gov and other registries for clinical trials.
- Strong written and verbal communication skills are required. An understanding of clinical research, biostatistics, and regulatory affairs is required.
- Excellent computer skills are required. Working knowledge of MS Word, Excel, PowerPoint is required. Omnicia template and PleaseReview experience preferred.