Medical Writer in the field of Clinical Development (m|f|d)

le contenu du travail

Company DescriptionMiltenyi Biomedicine is a newly established international biopharmaceutical company that develops innovative cell and gene therapies. We are focused on bringing cancer treatments and regenerative therapies to patients. Our initial focus is on difficult to treat hematological cancers using CAR-T technology whilst exploring treatments for solid tumors. We are currently in discussion with the FDA, EMA and Japanese health authorities regarding initiating pivotal Phase II trials. We strongly believe that despite promising developments, there is significant room to improve on current cancer therapies.Job DescriptionAs a Medical Writer you are part of our Miltenyi biomedicine business and within the Clinical Development Execution Services department responsible for medical writing aspects of our clinical development projects including preparation, development, review, revision and finalization of clinical documents for submission to regulatory authorities.

• You write and coordinate the development of briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, pediatric investigational plans, clinical overviews and summaries, safety update reports, integrated summaries of safety and efficacy and scientific abstracts.
• Your task is also the review and QC-check of clinical development documents prepared by external vendors and keep oversight of these documents
• In addition you are responsible for medical writing aspects during project preparation and deliver within budget and timelines.
• In cross-functional working groups you contribute to the overall project. management to facilitate efficient development and finalization of regulatory documents for submission. You provide advice on Medical Writing issues within crossfunctional project teams and help to resolve problems.

Qualifications

• Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
• Proven experience in Medical Writing in the field of Clinical Development is mandatory.
• Detailed knowledge of ICH guidelines and data protection law applicable to medical writing.
• The knowledge of immunology or onkology is an asset
• You have an excellent time and priority management and you work under pressure in an in-depth but still efficient and tructured manner.
• Fluency in English is a must, communication in German is a nice to have

Additional InformationWhat we offer

• A modern workplace and exciting opportunities in the development of technologies with a secure future
• Cross-border intercultural cooperation and short communication channels
• A collegial corporate culture and flexible working hours enable time management on your own terms
• Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University
• Diverse corporate benefits with regard to employee health, sport, and staff events

We look forward to your applicationIf you recognize yourself in the position described, please send us your application documents (cover letter, resume, references) online. Please state your salary expectations and earliest starting date.