BE - Study Responsible Scientist (Medical Affairs)

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

Scope of this project is to support the EMEA Medical Affairs Team as a Study Responsible Scientist for real world evidence Study with Spravato + support the preapproval Access program (NPP, named patient program).

OPEN FOR FREELANCERS!

PURPOSE OF THE PROJECT: 

The study is already set up and as more and more of the participating countries have the drug reimbursed, first patient in is expected soon, with an update towards the end of the year. 

The study will be generating real world data on the patient characteristics, outcomes and safety profile of Spravato treatment in TRD (treatment resistant depression). A sub-study is in place, with the purpose to acquire additional data by means of a digital solution (App and wearables), which will be used in a subset of patients, dependent of feasibility per country and patient preference.
Preapproval access program is already running, will run out over time as countries gain commercial access.
 

DUTIES & RESPONSIBILITIES:

• Support OpCos Medical Affairs to evaluate Investigator Initiated Study (IIS) proposals for scientific soundness and whether those are in alignment with the medical strategy.
• Support EMAD in all the Company Sponsored Studies (CSSs) activities (safety issues and signal detection review, and follow up the study milestones until publication plan execution).
• Support all Early Access Programs (EAPs) related activities. Give input and actively support the Program Leader Support Investigator Initiated Studies (IIS), by interactions with Investigators, respecting the internal procedures, and monitoring of the milestones planed in the agreement.
• Work with and support the EMPL and GCOMAO in the oversight of IIS according to internal procedures including Janssen Standard Operating Procedures (SOP) and Health Care Business Integrity (HCBI), and legal regulations.
• Responsible for medical oversight and all clinical aspects of clinical trial.
• Works on development of study protocol and takes ownership of clinical study reports and other related documents.
• Evaluates adverse events for relationship to treatment.
• Assists to Regulatory Affairs submissions and communications and determining requirements for any corrective actions or health authority reporting.
• May act as a medical contact of the company for health authorities concerning clinical/medical issues.
• Interprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions. Experience in setup, design and analysis of clinical trial data is helpful.
• To bridge in this function for the ongoing ECHO study as well as the NPP.

EXPERIENCE AND EDUCATION:

• BS or MS degree in Life Sciences.
• Minimum of 3 experience.

EXTRA INFORMATION:

• Flexible working hours.
• This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Randstad Professionals. They can offer you a freelance contract.