Regulatory medical writer needed

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Ballerup

The vacancy

Medical Communication in LEO Pharma is looking for a new medical writer who preferably has prior experience with clinical development. You will be joining our team of approximately 25 medical writers (internals and insourced consultants) and will be supporting LEO Pharma’s ongoing transition towards working with biological treatments for patients with more severe skin disease. You can look forward to gaining experience with writing clinical documentation and regulatory submissions.

At LEO Pharma, the medical writer portfolio of responsibilities spans the entire clinical development process, from trial outline 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 with medical writing and clinical documentation
  • 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


Organization

Medical Communication is divided into 2 organizational teams but feels and acts as 1 team. We belong to the Medical Department, which also includes a Clinical Disclosure team and 2 Medical Expert teams, all organized within Medical Sciences (MS).
Medical Communication provides professional and strategic medical writing expertise to development projects from the initial clinical phases to registration and beyond. The area is still being developed, and you will therefore be expected to contribute actively to the continued progress 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 drive as well as dive into these discussions and contribute with your experience, visions, and ambitions.

Practical

Application deadline: 20-Jul-2021
Preferred starting date: 01-Oct-2021
Location: Ballerup, Denmark
Position: Full time
Contact: Bente Riis, +45 2249 5017, or Laura Friis Eghorn, +45 3157 6489


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Ballerup.

Jobbet er oprettet på vores service den 8.6.2021, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Ballerup
  • Tirsdag den 20. juli 2021

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