Scientific Writer

For our Pharma client in Basel we are looking for a:

SCIENTIFIC WRITER

TASKS:

- Partner with and coordinate SMEs and experts (internally and externally) from MSAT Drug Substance and Drug product, QC, Regulatory CMC and QA to write and update Common Technical Documents (CTD) for regulatory submissions of CMC changes and for marketing licensure applications (MAAs/BLAs)
- Setup and maintain CMC changes in the data base, perform CMC applicant assessments and drive and support the CMC Change Management Process
- Ad hoc preparation of answers to questions from health authorities
- Focus on cGMP production for market supply
- Help to improve workflows and business processes

QUALIFICATIONS:

- 3 to 5 years' experience in international (bio)pharmaceutical industry
- Degree in Life Science or equivalent (Master or Bachelor)
- Profound experience in preparation and management of CMC documents, biotechnology expertise preferred
- Knowledge about CTD structure and content - drug substance (3.2.S) and drug product (3.2.P)
- Understand ICH guidelines and key regulatory standards
- Able to effectively manage multiple projects, deadlines and priorities simultaneously
- Proficient with Microsoft applications
- Strong interpersonal skills, excellent organizer
- Fluent in English. German, French and Spanish are an asset
- Flexibility to adapt to a fast moving and international environment
- Team player, task oriented and keen on working in a cross-cultural working environment

START DATE: ASAP
DURATION: 6 MONTHS + EXTENSION POSSIBLE
LOCATION: BASEL

Are you interested to work in this challenging position? Alessia Biassoli, Talent Resourcer, is looking forward to receiving your complete profile. Please send an e-mail (see below)

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