Senior Program Manager Global Specialty/Biosimilar Development (f/m/d)
Visualizza: 188
Giorno di aggiornamento: 22-10-2024
Località: Bad Vilbel Hesse
Categoria: Salute / Assistenza medica Medical
Industria: Chemical Manufacturing Pharmaceutical Manufacturing
Posizione: Mid-Senior level
Tipo di lavoro: Full-time
Contenuto del lavoro
"Caring for People’s Health as a Trusted Partner" - This mission motivates us at STADA every day to improve the health of people worldwide. With our wide range of generics, consumer health products and specialty pharmaceuticals, we offer patients, doctors and pharmacists a wide range of therapeutic options.
Around 13,000 employees live our values of Integrity, Entrepreneurship, Agility and One STADA. Together we are on an exciting growth journey and want to successfully shape the future of STADA.
Do you want to become part of a dynamic, international team and grow with us? Then apply now as Senior Program Manager Global Specialty/Biosimilar Development.
What you can expect:
- You are the accountable development lead for one or more Biosimilar and/or Specialty Programs covering program activities along entire product life cycle with:
- Focus on achieving marketing authorization by respective health authorities before LoE
- Support launch preparation and post-approval life cycle management / maintenance activities as needed
- As a project manager you take over the following tasks:
- Ensure development deliverables are done in time, at agreed costs and carefully balancing benefit & risks
- Manage cross-functional alignment and decision-making; take care that each voice is heard to achieve unbiased and fact-driven decision-making
- Provide scientific and / or technical expertise, e.g., in regulatory, tech transfer, etc.
- Be responsible for comprehensive project documentation, tracking and reporting (e.g., up to date project Gantt charts, project risk assessment, input into management presentations, support of department head in reporting compilation for senior management, etc.)
- You are in charge of relationship management for the alliance management with respective development or co-development partners:
- Manage joint decision-making as well as of potential escalation in case of non-agreement
- Participate in joint team meetings and Steering Committee according to project needs
- Support review of quality and supply agreements as needed
- You support the interaction with health authorities.
- You review all kinds of documents such as analytical and manufacturing documents, pre-clinical and clinical study reports, briefing books, etc.
- You support the pipeline for early assets (scientific support of due diligence process as needed).
Who we are looking for:
- You hold an University degree (master) in life sciences, e.g. Biologist/Biochemist, or comparable (PhD and/or MBA is a plus).
- You have multi-year (+ 8 years) of working experience in the life science sector.
- You have expertise in the development and manufacture of biotechnology-derived medicinal products, ideally in biosimilar projects.
- You have professional experience and/or educational background in project management.
- Your use of MS Office is professional.
- You are fluent in English (another language is a plus).
- You have strong communication skills, high sense of responsibility and problem-solving skills.
- As a proactive team worker you bring willingness to collaborate in internal as well as in inter-company cross-functional teams.
What we offer
- An open corporate culture with fast decision-making processes and a lot of potential for your personal development
- Individual development and training opportunities
- Flexible working hours and mobile working (depending on the job profile)
- Job ticket for the RMV region and Job Bike
- Reimbursement of costs for public transportation
- Childcare allowance
- Health-promoting offers such as Wellpass or the STADA Gym (free of charge)
- Numerous additional benefits such as "future payment", group accident insurance, supplementary pension scheme, and chemical industry pension fund
- And much more...
We look forward to receiving your application via our career portal. At jobs.stada.com you will also find numerous other job opportunities, as we are always looking for motivated talents who can strengthen our team with their expertise and personality. Do you have further questions? Then please reach out to recruiting@stada.de.
Scadenza: 06-12-2024
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