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reference: 4897749

documentId: 4897749

connectionPointId: 7

lastModificationDate: 1540897866760

stillingsbetegnelse:
Experienced regulatory medical writer looking for a challenge?

jobbeskrivelse:

Due to our 2025 strategy of investing heavily in development, LEO Pharma is now looking for a medical writer who has written his or her share of trial documents and is now ready to start the journey towards becoming experienced with project level work. You will be joining our Medical Communication team and will be supporting LEO’s ongoing transition towards working with biological treatments for the more severe dermatology patients. You can look forward to gaining experience with working in a partner setting and with preparation for a large submission. 
At LEO, the medical writer portfolio of responsibilities spans the entire clinical development process, from protocol to CTR, from database registration tasks to plain language summaries, from support to clinical development plans and labelling all the way to interacting with the regulatory authorities. 
If this sounds tempting, please apply as soon as possible. We will start interviewing as soon as we receive applications from relevant candidates.

 The preferred candidate

• University degree in science (MD, MSc, MSc Pharm or equivalent)
• Experience as a Medical Writer with experience in compiling, analysing, and preparing scientific reports and documentation for clinical trials 
• The ability to plan, drive, manage, structure, and write large, clear, concise, targeted and reader-friendly, regulatory, scientific, and medical documents in a collaboration with many stakeholders 
• Superb command of both written and spoken English, strong communication skills, and an appreciation of well-written documents
• Knowledge of clinical development, GCP, statistics and scientific research methods, and applicable regulatory guidelines
• Customer focus, able to manage ambiguity, ensures accountability

 About Medical Communication

In Medical Communication you will join a group of 15 skilled and energetic colleagues. We are part of Biometrics, which also includes Biostatistics, Statistical Programming, and Data Management. Biometrics is organised in Global Clinical Operations (GCO). 
Medical Communication has two primary deliverables:

• To provide professional and strategic medical writing expertise to development projects from the initial clinical phases to registration and beyond
• To ensure compliance with internal and external requirements for disclosure of clinical trial information.

We are a relatively newly established function (6 years), and you will therefore be expected to contribute actively to the continued development of the Medical Communication function in LEO Pharma including giving input on processes, tasks and sourcing strategy. We strive to seek out intelligent implementation of guidelines and regulations and have lively discussions and strong opinions on best practices for producing high quality documents. We expect you to dive into these discussions and contribute with your experience, visions and ambitions.

 

Practical

Application deadline: 13 November 2018
Preferred starting date: 1 January 2018
Location: Ballerup, Denmark 
Position: Full time
Contact: Louise Broge, +45 3167 8629

numberOfPosts: 1

jobCategoriesCodes_0: http://data.europa.eu/esco/isco/C2641

abstractJV_contact_0: Please apply using one of the specified channels

positionTypeCode: directhire

contractTypeCodes_0: fulltime

Arbejdsgiver Navn: LEO PHARMA A/S

source: DK-STAR