(Senior) Medical Writer

DescriptionOUR COMPANYAt Boehringer Ingelheim we develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals.

As a family owned company, we focus on long-term performance. We believe that, if we have talented and ambitious people who are passionate about innovation, there is no limit to what we can achieve;

after all, we started with just 28 people. Now, we are powered by 50,000 employees globally who nurture a diverse, collaborative and inclusive culture.

THE POSITION Making science clear to improve patients’ lives. At Global Medical Writing, we provide end-to-end contributions to clinical development programs by writing key regulatory clinical documents.

We currently have opportunities for (Senior) Medical Writers in our Therapeutic Area (TA) Medical Writing (MW) teams (CardioMetabolism & Respiratory;

Inflammation; Oncology; CNS, retinopathies & emerging areas).Tasks & responsibilitiesIn your new role as Medical Writer : You are responsible for the preparation of clinical documents required for advancing clinical development programs (e.

g. clinical trial reports, investigator’s brochures, clinical trial protocols). This includes writing, planning, developing of document strategies, resolving and integrating review comments, and overseeing of timelines.

You ensure quality of clinical documents assigned to external providers by appropriate oversight and training.Furthermore you develop in-depth knowledge in the assigned TA and in one or more of the main document types of the function portfolio.

You share knowledge with other medical writers.You advance MW standards by contributing to process improvement initiatives and working groups with cross-functional impact.

In your new role as a Senior Medical Writer : You assume the role of project medical writer across all phases of clinical development.

You proactively coordinate with other functions, plan timelines, and devise and execute document strategy in a clinical development program.

You are responsible for the preparation of clinical documents required for phase transitions and regulatory approval of Boehringer Ingelheim (BI) development compounds (e.

g. clinical trial reports, clinical summaries, investigator’s brochures, briefing books, clinical trial protocols), regulatory documents in the post-marketing setting, and value dossiers supporting health technology assessments.

Moreover you ensure quality and timeliness of clinical documents assigned to external providers by appropriate oversight, training, budget planning, and cost control.

You contribute to BI-internal international cross-functional working groups, and global SOP development.You assume the role of an expert in the assigned TA, including thorough knowledge and understanding of the document and analysis standards.

You transfer knowledge when mentoring and training other medical writers.RequirementsDoctoral degree in Pharmacy, Medicine or Life Science with multiple years of experience in scientific and / or regulatory medical writing or comparable degree with long term professional experienceSound knowledge of medical concepts, statistics, pharmacokinetics, and pharmacodynamicsAbility to independently and effectively communicate complex clinical information in writingAbility to manage projects effectively across regions and in matrix environmentsExcellent written and verbal English skillsAdditional requirements for the Senior position : Longstanding experience in regulatory medical writing (as a Medical Writer or an equivalent role)Proven ability to work globally on clinical documents for submission to health authorities in major regions such as US, EU and AsiaEMWA / AMWA foundation or advanced certificate is an assetWHY BOEHRINGER INGELHEIM?

This is where you can grow, collaborate, innovate and improve lives. We offer challenging work in a respectful and friendly global working environment surrounded by a world of innovation driven mindsets and practices.

In addition, learning and development for all employees is key, because your growth is our growth. We also offer a competitive salary, generous amount of vacation time, and numerous benefits towards your wellness & financial health and work-life balance.

Plus, an onsite gym (Ingelheim), in-house doctor and best-in-class cafeterias and coffee bars to keep you energized and healthy.

To learn more about what benefits could be waiting for you, please visit our Career area. Want to learn more about us? Visit Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture.

We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin.

READY TO CONTACT US? Please contact our Recruiting EMEA Team, Tel : +49 (0) 6132 77-173173Not exactly the position you are looking for but have someone else in mind?

Share it via the button on the bottom of the page with friends or colleagues who might be interested.Job Field : Clinical OperationsOrganization : DE-Boehringer Ingelheim Pharma GmbH&Co.

KG (Germany)Schedule : Full-time