Associate Director – Medical Writing

Job Description

Job 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.

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.

Experience:

• 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, Skills and Abilities:

• 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, Power point is required.