Global Regulatory Dataset Manager
Global Regulatory Dataset Manager - (160000AZ)
About the Company
Actelion Pharmaceuticals Ltd. is a leading biopharmaceutical company employing over 2,500 dedicated professionals covering all key markets around the world – including Europe, the US, Japan, China, Russia and Mexico. Headquartered in Allschwil, near Basel, Switzerland, our functional, award-winning Actelion Center is a symbol of our innovative spirit and culture
We are searching for breakthrough medicines for high unmet medical needs and this inspires and motivates all of us to work towards achieving our overriding mission: to treat more patients with groundbreaking therapies.
Besides highly competitive compensation and tangible benefits, would you like to have a noticeable impact and enjoy our culture of innovation, trust and teamwork? Do you want to grow in a different kind of company with an enthusiastic, stimulating environment fostered by open communication and a results-driven approach? Then we welcome your application to join our team in the role of Global Regulatory Dataset Manager, based in Allschwil.
- Lead collaboration between relevant functions (e.g. Biostatistics, Data Management, Clinical Pharmacology, Preclinical, Drug Regulatory Affairs) to produce compliant datasets for inclusion in regulatory submissions across the entire lifecycle of drug development
- Work in teams on the processes and procedures related to datasets and ensure that company processes for current and future requirements for datasets are "fit for purpose"
- Contribute to relevant project teams to guide them with dataset related information during the design of relevant studies; and during the creation and alignment phase of submission planning
- Maintain knowledge of regulatory developments related to datasets/data standardization, assess impact on Actelion organization and projects, and make recommendations for appropriate action
- Develop and provide training on data standards, datasets and related information, as needed
- Accountable for ensuring submission datasets conform to the data standards expected by regulatory agencies, in collaboration with contributing line functions, including traceability from data collection to submission dataset
- Keep abreast of industry trends in data mapping, standards, compliance methodologies and metadata management
- Establish and maintain processes to ensure the company is fully prepared to submit compliant datasets not only in the US, but also in other regions (e.g. Europe, Japan)
- Setup and lead Dataset Core Teams working on major regulatory submissions, including hands-on work on submission dataset.
- Bachelor’s Degree in Sciences; secondary degree (e.g. MSc) preferred.
- At least 3 to 5 years of experience in the pharmaceutical industry and/or working for a regulatory authority; recent experience in the area of regulatory submissions which contained datasets preferred
- In depth knowledge and understanding of current regulatory dataset standards and requirements such as CDASH, SEND, SDTM, ADaM, define.xml, etc., as well as CDISC controlled terminology.
- In depth understanding of the technology, processes and procedures involved in preparing datasets for submissions
- Hands-on experience of preparing, reviewing and submitting CDISC-compliant datasets to the FDA
- Knowledge of the emerging regulatory landscape in US, Japan, Europe and other countries
- Excellent relationship and social skills with proven ability to influence strategic direction across functions in multicultural environment
- Ability to multi-task across projects and products, effectively deal with ambiguity, and challenge status quo, be proactive and innovative
- Proven ability to drive things through to completion, with an attention to detail
- Excellent communication, interpersonal, negotiation and problem solving skills
- Strong team player, with experience working in cross-functional and global teams, but also able to work independently
- Spoken and written fluency in English mandatory. Additional language skills are a plus.
What Actelion Offers
- A competitive salary and generous social benefits
- The possibility for development and advancement within our dynamic organization
- The innovative and stimulating atmosphere of a multicultural environment
The research facilities are located in Allschwil, Switzerland, a suburb of Basel on the borders of France and Germany.
Primary Location: CH-BL-Allschwil
Job: Regulatory Affairs
Job Type: Standard
Job Posting: Aug 15, 2016