Associate Director Medical Writing

Integrated Resources, Inc.; United States; Sur place; USD 170 000 - 210 000; Plein temps

Résumé du poste

A leading healthcare firm is seeking an Associate Director for Medical Writing, responsible for leading the scientific and regulatory writing activities for product development. Candidates must have at least 10 years of pharmaceutical writing experience, a strong command of regulatory guidelines, and the ability to manage a team. The role emphasizes effective communication and strategic planning, ensuring the delivery of high-quality documents in compliance with industry standards.

Qualifications

• Minimum of 10 years in medical writing within pharmaceuticals or biotech.
• 8 years of management experience in writing roles.
• Demonstrated experience in writing regulatory documents.
• Minimum 10 years supervisory experience.
• Experience as primary author of protocols, IBs, CSRs, IND/NDA sections.

Responsabilités

• Lead scientific, medical, and regulatory writing activities.
• Manage and oversee a team of medical writers.
• Ensure timely presentation of clinical data according to strategic plans.
• Conduct and lead document production meetings.
• Ensure timely presentation of clinical data according to budget and timelines.
• Develop and enforce department guidelines, style guides, and templates (protocols, IBs, CSRs).
• Oversee CT.gov updates and data entry when required.
• Organize and lead document production meetings and prepare meeting minutes.

Connaissances

Pharmaceutical writing experience

Supervisory experience

Regulatory knowledge

Analytical thinking

Strong communication skills

ICH/FDA guidelines

Data interpretation

Presentation skills

MS Word/PowerPoint

Communication skills

Biostatistics understanding

Formation

Bachelors or Masters degree in a scientific discipline

PhD in a scientific or life sciences discipline

PhD preferred

Outils

MS Word

MS Excel

PowerPoint

Omnicia template

PleaseReview platform

Description du poste

Overview

Title: Associate Director, Medical Writing

Duration: 10 months assignment with possibility of extension.

Job Description

• 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.
• 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 to 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

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, Power point is required.
• Omnicia template and PleaseReview experience preferred.