The Johnson & Johnson Group of Consumer Companies is recognised as a world leader in providing health and beauty products and solutions across Baby, Beauty, Healthcare and OTC medicines. The breadth and depth of our product portfolio is truly impressive and constantly expanding as we strive to bring science to the art of healthy livingTM.
Each day, millions of people of all ages in homes around the world use products from one or more of our consumer healthcare companies. These products keep babies clean and comfortable, nourish and moisturise skin, prevent sunburn, hold allergy symptoms in check, help heal wounds, reduce fevers, and tame the urge to smoke.
Each one of our consumer health businesses embraces cutting-edge science to create products that are doctor-recommended, helping you and your family to be well and stay well. As a result, our consumer companies produce many of the world's most trusted brands. Taking health and well being to the next level..
Oversees medical and safety aspects of clinical studies and market research activities. Responsible for reviewing essential study documents (eg, protocols and informed consents), conducting documented reviews of medical safety data, escalating any identified safety signals per applicable SOPs, and providing input regarding medical and safety questions as needed. Provides team support for the clinical study team.
Main tasks:
- Provide sponsor medical and safety oversight of clinical studies and market research activities.
- Review and approve essential documents to ensure patient/subject safety, including protocols and Informed Consent Documents and develop Medical Safety Oversight Plans as applicable
- Conduct documented review of adverse events, serious adverse events, and pregnancy cases for each study
- Review concomitant medications and subject medical histories to confirm site compliance with protocol inclusion and exclusion criteria
- Review coding of adverse events and concomitant medications
- Participate in study team meetings as applicable, including presenting safety and medical topics at site initiation trainings
- Review Clinical Study Reports for safety content and potential safety signals
- Identify and escalate Safety signals from studies per appropriate SOP
- Answer questions on eligibility when the Principal Investigator or site staff seek clarification of inclusion/exclusion criteria
- For studies in regions where it is permitted per regulations, fulfill Study Physician role on designated studies when the Principal Investigator is not medically qualified (includes determining eligibility from a medical perspective and performing AE assessments)
- May assist with other clinical study activities such as, but not limited to, medical writing and literature reviews
Qualifications
Crucial requirements for candidates:
- A Doctor of Medicine or equivalent
- Minimum one (1) year of experience in clinical practice, clinical research or equivalent such as Medical Affairs or Pharmacovigilance
- A working knowledge of MedDRA (adverse event dictionary) and WHO Drug dictionaries is a plus but not required.
- Advanced knowledge of English, fluent Polish
In return, we offer:
- Unique opportunity to become part of a global consumer healthcare market leader
- Versatile and fulfilling role in a dynamic and international corporation
- Work in a supportive and highly professional team
- Further opportunities for professional development and career growth
- Motivating financial remuneration & numerous employee benefits
