Associate Director, Medical Writing - Experimental Medicine - Remote

Boehringer Ingelheim•Ninilchik, AK

15d•$165,600 - $248,400•Remote

About The Position

Boehringer Ingelheim is seeking an Associate Director to join its Medical Writing department. The role devises and executes document strategy and timelines for clinical development programs, including serving as Asset Medical Writing Lead. The Associate Director independently writes and manages key global clinical documents across cross-functional project and study teams, and contributes to process improvements, working groups, and SOP development. The role also trains, mentors, and oversees internal and external medical writers. The position focuses on early clinical development and requires project-level and study-level document preparation, planning, coordination, and oversight. The role works across functions to ensure quality, timeliness, and successful finalization of clinical documents, and contributes scientific and regulatory expertise to project teams. It also represents the Experimental Medicine Medical Writing function in cross-functional working groups and supports global SOP development. This position is remote-based. The base salary range is $165,600 to $248,400 USD. The position may be eligible for a role-specific discretionary bonus, relocation assistance, and/or other compensation elements. Benefits include medical, dental, and vision coverage, retirement savings opportunities, paid time off, paid holidays, disability and life insurance, and other company-sponsored benefits.

Requirements

Advanced degree (e.g., PharmD, PhD, MD) from an accredited institution, preferred, with at least four years of relevant experience in regulatory medical writing or scientific communications in the healthcare industry; alternatively, a master's degree with at least six years of experience or a bachelor's degree with at least eight years of experience.
Experience as a project medical writer.
Demonstrated regulatory-writing expertise, including protocols, clinical trial reports for early clinical phases, investigator's brochures, and other study- and project-level clinical documents.
Understanding of international writing standards and conventions; the business impact of timelines for key clinical documents; medical concepts, statistics, pharmacokinetics, and pharmacodynamics; the clinical development process; and relevant global and local regulatory guidelines.
Knowledge of requirements for regional and local marketing approvals.
Ability to communicate complex clinical information independently and effectively in writing for target audiences and to comprehend and interpret clinical data.
Ability to manage projects across regions and in matrix environments, including time management and oversight of external providers.
Ability to manage parallel tasks and variable workloads, communicate effectively in international cross-functional teams, manage conflicting interests, and contribute to process improvements.
Proficiency in word processing and presentation software.
Excellent written and verbal English skills.
Scientific and analytical thinking, strong interpersonal and social skills, presentation skills, diplomacy, and cultural sensitivity.

Nice To Haves

Experience working globally on clinical documents for submissions to health authorities in major regions, including the US, EU, and Asia, and knowledge of the assigned therapeutic area.
Expertise in the assigned therapeutic area and its clinical standards, including new medical or statistical approaches.

Responsibilities

Serve as project medical writer across early clinical development, coordinating with other functions, planning timelines, and devising and executing document strategy.
Write key clinical documents for assigned projects and oversee regulatory documents written by internal or external medical writers.
Contribute to scientific and regulatory discussions within project teams and demonstrate expertise in the assigned therapeutic area.
Prepare project-level and study-level clinical documents required for phase transitions and regulatory approval.
Plan document and submission timelines, develop document strategies, resolve and integrate review comments, and oversee timelines to support timely document finalization.
Coordinate proactively and continuously across functions to ensure successful completion of clinical documents.
Oversee external providers to ensure the quality and timeliness of assigned documents, including training and cost control, and implement medical-writing standards in provider governance.
Contribute to internal international cross-functional working groups and global SOP development.
Represent the Experimental Medicine Medical Writing function in cross-functional working groups, interact with leadership, influence strategic objectives, and support their implementation.
Develop and share in-depth expertise in major indications and key document types; mentor and train other medical writers and advise other functions.
Apply global, local, and regional regulatory guidelines for clinical documents and comply with applicable SOPs and company policies.