Senior Coding Specialist

Actelion Pharmaceuticals Ltd

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Senior Coding Specialist

Senior Coding Specialist - (170000DM)

Actelion Pharmaceuticals Ltd., a Janssen Pharmaceutical Company of Johnson & Johnson, is recruiting for a Senior
Coding Specialist in Allschwil .

As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without
disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science. We collaborate with the world for the health of
everyone in it.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the
spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.

Job Responsibilities

- Performs clinical trial data coding activities according to the internal standards and regulatory requirements
- Ensures correctness and consistency of coding within the dictionaries of allocated studies
- Informs and suggests solutions on coding related issues of allocated studies
- Produces coding listings for each dictionary of allocated studies for the review by the other functions
- Interacts with other functions to improve the coding of allocated studies
- Interacts with Drug Safety group for reconciliation
- Advises in the choice of the medical/project specific dictionaries to be used for allocated studies
- Represents the Clinical Data Coding Group at Clinical Trial Team meetings for allocated studies
- Meets study timelines in terms of coding activities
- Provides training to Coding Specialist(s) if needed
- Oversees the work of Coding Specialist(s) to ensure correctness and consistency of coding within the dictionaries
- Presents Coding related topics at Clinical Trial Team, Investigators and Monitors meetings
- Forecasts coding group resource requirements
- Performs the migration of the standard dictionaries (Medical Dictionary for Regulatory Activities (MedDRA), World
Health Organization Drug Dictionary Enhanced (WHO DDE) in accordance with the regulatory requirements
- Participates in development and review of Quality System (QS) Documents for the Clinical Data Coding Group
- Performs quality control to ensure correctness and consistency by review of coding listings
- Interacts with the study team for support, i.e. on forbidden medication, WHODRUG Standardized Drug Groupings (SDGs),
Standard MedDRA Queries (SMQs)

Candidate Requirements

- Recognized university degree in medicine, pharmacy or related disciplines
- Minimum 5 years of experience in the pharmaceutical field/clinical research within a pharmaceutical company or a
clinical research organization
- Good knowledge of coding principles and medical terms
- Good knowledge of international clinical research regulations and requirements (e.g. International Conference on
Harmonization Good Clinical Practice (ICH-GCP)
- Good knowledge of coding of clinical trial data
- Ability to lead and coordinate the activities related to the coding process
- Good organizational and presentation skills
- Fluent in written and spoken English

If you are interested in making an impact by working in a culture of innovation, trust and teamwork, we welcome your

Primary Location

: CH-BL-Allschwil


: Clinical Development


: Full-time

Job Type

: Standard

Job Posting

: Dec 8, 2017