We are growing, grow with us!
Want to work in a dynamic company with daily new challenges and opportunities? Then PharmaLex is your career opportunity!
PharmaLex is one of the leading service providers for the global pharmaceutical industry. We offer end-to-end regulated services and specialize in all aspects of approval and maintenance of medicinal products and medical devices. We support pharma companies throughout the entire product lifecycle, ensuring initial submissions and approvals as well as keeping compliance with pharmaceutical regulations worldwide. Our services extend way beyond market approval, providing high level strategic consultancy as well as hands-on work to extend product registrations into new markets across all regions of the world.
The success of our company grows with the excellent expertise and the high motivation of our employees.
If for you, your profession is not only a job but also a vocation and you enjoy working with people and in teams as part of a global organization, then you are very welcome to join us.
To strengthen our successful team, we are looking as of now for a
Senior Manager Scientific Affairs (m/f/d)
- Distribution and oversight of tasks to writers (as Project Lead / Lead Writer) based on a global capability matrix and discussion with the International Service Lead, for Scientific, Regulatory/Medical/ Writing and the writer`s Line Manager
- Target completion dates of writing projects are defined on a case-by-case basis in negotiation with clients and writers
- Regulatory writing of nonclinical and clinical documents (eCTD) to support drug development for obtaining marketing authorization in the EU and US (e.g. MAA, NDA, BLA, IMPD/IND, PIP, ODD, Scientific Advice)
- Communication and coordination of writing activities with clients and internal functions (e.g., regulatory strategy, CMC, publishing)
- Project management and timelines
- Advanced degree in life science (e.g. biology, pharmacy, nutritional science), medic, veterinarian, doctorate desired. Previous scientific/academic publications are a plus
- At least 3 years of relevant professional writing experience (e.g., regulatory/medical writer or freelancer), additional training in RegAffairs or clinical/CRO experience a plus
- Excellent written and spoken English
- Very good knowledge of the MS Office package, ability to follow defined processes, responsibilities and organisational structures of pharmaceutical companies. Knowledge of electronic document systems / platforms / “data rooms” (e.g., SharePoint, Teams, Veeva, etc.) a plus
- Excellent written and spoken expression of scientific results, possibly obtained from previous publication experience or presentations at scientific events, ability to present complex scientific issues in a transparent, concise, and convincing manner to clients and authorities, flexibility to work on several projects concurrently
- Quick comprehension, ability to recognize the essential massaging, solution-oriented work, customer-oriented service mentality, and a team player. Ability to grow and respond positively to constructive criticism
- Varied and challenging activities
- Very open, pleasant and collegial cooperation
- Plenty of room for creative ideas and personal responsibility
- Employer with short decision-making processes and flat hierarchies
- Continuous development opportunities through exchange of knowledge and experience as well as further training courses
- Compatibility of work, family and private life
- Flexible working hours; full-time
- Possibility of working in a home office
- Company pension scheme with employer's contribution
- Fresh fruit, muesli and delicious coffee for our employees
- Health management at the workplace (active break, internal back training, etc.)
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us:
Manager Human Resources
Agencies only by prior agreement for the specific job opportunity.