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INTRODUCTION

Boehringer Ingelheim is currently seeking a talented and innovative Associate Director to join our Medical Writing department.

The Associate Director of Medical Writing devises and executes document strategy and timelines in clinical development programs when assuming the role of Asset Medical Writing Lead with the ultimate goal of creating value for patients in need. In this role, you will independently write and manage key global clinical documents in global, cross-functional project- and study teams, pass on experience and in-depth knowledge when training, mentoring and overseeing internal and external medical writers and contribute to cross-functional process improvements, working groups and SOP development.

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

DUTIES & RESPONSIBILITIES

• Assume the role of project medical writer across early clinical development. Proactively coordinate with other functions, plan timelines and devise and execute document strategy. Write key clinical documents in the assigned project and oversee regulatory documents written by other internal or external medical writers. Contribute to scientific and regulatory discussions within the project teams. Demonstrate expertise in the assigned therapeutic area (TA).
• Responsible for the preparation of clinical documents on project- and study-level. Document types comprise clinical documents required for phase transitions and regulatory approval of BI development. This includes writing, planning of document and submission timelines, developing of document strategies, resolving and integrating review comments and overseeing of timelines. Requires proactive and continuous cross-functional coordination to ensure timely and successful document finalization.
• Ensure quality and timeliness of clinical documents assigned to external providers by appropriate oversight, training and cost control. Implement MW standards in the governance of external providers.
• Contribute to BI-internal international cross-functional working groups and global SOP development. Represent the ExpMED MW function in cross-functional working groups; interact with leadership, influence related strategic objectives and ensure their implementation.
• Assume the role of an expert in the assigned TA, including thorough knowledge and understanding of the document and analysis standards. Develop and share in-depth knowledge in major indications and in one or more of the main document types of the function portfolio. Transfer this knowledge when mentoring and training other medical writers. Give expert advice to other functions.
• Apply regulatory guidelines related to clinical documents on global, local and regional level. Comply with all applicable SOPs and company policies.

REQUIREMENTS

• Advanced degree (e.g., PharmD, PhD, MD) from an accredited institution is preferred with at least four (4) years of relevant experience in regulatory medical writing/scientific communications in the healthcare industry.
• In addition, a Master´s degree from an accredited institution with a minimum of six (6) years or a Bachelor´s degree from an accredited institution with a minimum of eight (8) years of experience in scientific communications and/or regulatory medical writing will be considered.
• Experience as project medical writer.
• Demonstrated expertise in regulatory writing, including protocols, clinical trial reports of early clinical phases, investigator´s brochures, and other clinical documents on study- and project-level.
• Understanding of:
• International writing standards and conventions
• Business impact of timelines for key clinical documents
• Medical concepts, statistics, pharmacokinetics and pharmacodynamics
• Clinical development process and relevant global and local regulatory guidelines
• Knowledge of requirements for regional and local marketing approvals.

Ability to:

• Independently and effectively communicate complex clinical information in writing for the target audiences.
• Comprehend and interpret clinical data.
• Manage projects effectively across regions and in matrix environments, including time management and oversight of external providers.
• Manage parallel tasks and variable workload.
• Communicate effectively in international cross-functional teams.
• Manage conflicting interests.

• 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.
• Cultural sensitivity.

REMOTE: this position is considered remote based.

DESIRED EXPERIENCE, SKILLS, AND ABILITIES

• Experience working globally on clinical documents for submission to health authorities in major regions (US, EU, Asia) and knowledge in the assigned TA.
• Expertise in the assigned TA and its clinical standards, including new medical or statistical approaches.

COMPENSATION DATA