Remote Associate Director, Medical Writing Lead

Boehringer Ingelheim; Ridgefield (CT); Remoto; USD 166.000 - 248.000; Tempo pieno

Descrizione del lavoro

Boehringer Ingelheim is seeking an Associate Director to join the Medical Writing group. The role drives document strategy and timelines for global clinical documents, mentors internal and external writers, and contributes to SOP development and process improvements.

You will work across global cross-functional teams in a remote-based position, leveraging advanced clinical writing to ensure timely delivery of high-quality regulatory documents and support patient value creation.

Competenze

• Advanced degree (PharmD/PhD/MD) with 4+ years of regulatory medical writing experience.
• Experience as project medical writer and regulatory writing for protocols, TRs and IBs.
• Understanding of international writing standards and global guidelines.
• Experience coordinating cross-regional teams and timelines.
• Ability to manage timelines, reviews, and cross‑functional collaboration.

Mansioni

• Lead project medical writing across early clinical development and coordinate with functions.
• Prepare clinical documents for phase transitions and regulatory submissions; oversee reviews.
• Ensure quality and timeliness of documents by external providers; monitor costs.
• Represent ExpMED MW in cross‑functional groups and SOP development.
• Mentor and train other medical writers; share in‑depth knowledge of TA and docs.
• Apply regulatory guidelines at global, local and regional levels; comply with SOPs.
• Communicate complex clinical information clearly to target audiences.
• Manage multiple tasks and matrix environments with effective time management.
• Proficient in word processing and presentation software.
• Exhibit excellent English, strong interpersonal and presentation skills.

Conoscenze

Regulatory writing

Project management

Written English

Oral communication

Cross-functional collaboration

Attention to detail

Presentation skills

Diplomacy

Cultural sensitivity

Formazione

PharmD, PhD, or MD

Master's degree with 6+ years

Bachelor's degree with 8+ years

Descrizione del lavoro

Boehringer Ingelheim is seeking an Associate Director to join the Medical Writing group. The role drives document strategy and timelines for global clinical documents, mentors internal and external writers, and contributes to SOP development and process improvements.

You will work across global cross-functional teams in a remote-based position, leveraging advanced clinical writing to ensure timely delivery of high-quality regulatory documents and support patient value creation.