Medical Writer (m/f/d)

 

Country: Germany

City: Aachen

Department: Research & Development

Job ID: 43738

If you’re passionate about changing lives for the better, this is the opportunity you’ve been waiting for. In Research & Development, we’re continuously exploring innovative new treatment options to make a stronger, more positive impact on the lives of the patients we serve. You’ll work with talented colleagues in a state-of-the-art Research & Development environment, developing innovative medicines that change the live of patients for the better and help us make progress towards our vision of a world free of pain. Join us today, and discover the difference you can make.

What the job looks like
Each day you'll enjoy a variety of challenges, such as:

• Lead the development of protocols and amendments, Investigator Brochure updates, Investigational Medicinal Product Dossier updates including development and management of timelines to support large clinical programs.
• Lead the development of or participate in the review of clinical study reports by analysing complex data and ensure timely delivery of the documents.
• Represent medical writing in cross-functional teams, such as product, project and/or regulatory submissions teams; providing guidance for optimal presentation of data to achieve document intent.
• Plan and oversee assigned medical writing deliverables with responsibilities including development and management of document timelines and resource planning for assigned projects.
• May serve as lead medical writer and department representative on a medium to large development program.
• Participate in development/improvement of document standards, templates, and processes and other non-medical writing activities.
• May also participate in other special projects and/or represent Medical Writing in other cross-functional initiatives.
• Where applicable, oversees the work of external contractors supporting deliverables and other activities.
• May be involved in Transparency and Public Disclosure activities when required
• Ensure own work complies with established practices, policies, and processes, and any regulatory or other requirements.
• Act as a back-up for other functions within Medical Writing and Public Disclosure when required.

What you’ll bring to the table
To make the most of this role and truly thrive, you should have:

• Master’s or a Doctorate degree with 3+ years of relevant experience (such as direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment)
• Direct experience in protocol authoring or management as a lead author is essential
• The ability to understand the needs of a clinical development team and manage their expectations and to use various communication styles to work effectively with teams
• The ability to balance integrity and efficiency when managing attention to detail
• In-depth knowledge of industry regulations, regulatory documentation requirements, and medical writing processes and standards
• Proficient in the use of Microsoft Office and document management systems
• Experience in the biopharma industry is strongly preferred.

This is a part-time position of 80%.

$ads={2}

 

.

$ads={1}