Vacancies

REPORTING TO THE REGULATORY AFFAIRS DIRECTORATE, YOUR OVERALL MISSION WILL CONSIST OF:

• Organising, managing and coordinating Regulatory Affairs activities of the products for which you are responsible, ensuring respect of applicable regulations,
• Ensuring maintenance of the validity of existing MAs under your responsibility in line with the company strategy.
• Being the contact for healthcare authorities in the context of the various regulatory procedures.
• Implementing the technical/regulatory strategy on current projects.
• Carrying out regulatory monitoring.
• Implementing the Transparency policy with regard to communication with healthcare professionals.
• Carrying out your functions in full respect of the Charter and Certification Standard for solicitation or market research information activities aiming for the promotion of drugs from March 2017.

YOUR MISSION IS DIVIDED ACROSS FOUR MAJOR FUNCTIONS

1 – Registration and maintenance of product MAs

• Constituting market authorisation dossiers, coordinating and planning the submission of registration dossiers, ensuring coherence between the constituent portions of the dossier (pharmaceutical, preclinical, clinical).
• Monitoring regulatory dossier projects under your responsibility
• Monitoring the assessment of the dossiers by the healthcare authorities and answering the various questions from the authorities throughout the life of the product.
• Managing, in conjunction with our international partners, the scientific support necessary for export registrations of these products.
• Implementing the necessary actions to obtain MAs and rectifications in the shortest timescale possible.
• Manage rectifications, annexes and legal statements as soon as feedback is received from the authorities.

2 – Packaging items control

• Validating the packaging items created or modified in compliance with the MA of the different products and applicable procedures.

3 – Advertising control

• Carrying out the regulatory monitoring of promotional elements and ANSM follow-up.

4 – National and international regulatory monitoring

• Ensuring the monitoring of regulatory activities on internal databases.
• Participating in department meetings regarding regulatory strategies
• Providing consultancy and assistance on regulatory aspects for other departments.

PROFILE

Pharmacist – at least 5 years experience in a similar environment and post (regulatory affairs).
English : fluent
Position available immediately in CDI, full-time
Work from home 2 days a week.

Bioprojet is a pharmaceutical company headquartered in Paris. The company was established in 1982 – and has its own fundamental research centre – with a vision to provide novel treatment options for people living with rare diseases who have unmet medical needs.

SUMMARY

The Medical Lead, Clinical Development is responsible for leading and driving inputs into clinical development strategy for Bioprojet’s key programs and studies. This role will act as medical lead on these programs as well as sponsor’s safety physician. This role will work very closely with Bioprojet’s Clinical Operations team and partner with the lead Clinical Trial Manager and the Clinical Research Organisation (CRO) in the operational delivery of clinical studies. This position offers an exciting opportunity in a growing organization with multiple development programs to provide an impact from the start and then grow as the company builds out its clinical development enterprise.

DUTIES AND RESPONSIBILITIES

Contribute to build and manage the clinical strategy lead for clinical programs and studies.
Perform clinical studies medical monitoring with primary responsibility for patient safety and conduct of assigned trials as well as overall data interpretation and safety surveillance.
Establish and approve scientific methods for design and implementation of applicable clinical protocols, data collection systems, and final reports.
Responsible for leading/assisting in design of clinical development plans and overall strategy for compounds, therapeutic classes of compounds or indications in the areas of interest to Bioprojet Pharma.
Draft clinical trial protocols and lead cross-functional teams in the review and efficient finalization of clinical protocols and related clinical documents.
Collaborate with pre-clinical and translational sciences, and senior management in assessing requirements for emerging products of business development opportunities.
Provide leadership on cross-functional product development team(s).
Participate in identification, selection and conduct of negotiations with clinical research sites and investigators.
Participate in the selection and management activities of CROs.
Supervise project team members in planning, conducting, and evaluating clinical trials.
Drive fiscal responsibility with the operational budget and cost savings initiatives.
Maintain compliance with Standard Operating Procedures (SOPs) and policies and perform all duties consistent with Good Clinical Practices (GCP).

QUALIFICATIONS

Medical Doctor (MD) required, with experience in Neurology or Psychiatry preferred (Board Eligible (BE)/Board Certified (BC) Neurologist is a plus).
3-5+ years of experience in a CRO/pharma/biotech organization with experience in GCP; pharmaceutical experience is most preferred.
3+ years of Central Nervous System (CNS) clinical research experience with ability to draft clinical development plans, clinical trial protocols and related clinical documents.
Experience working in a medical monitor/ safety physician role with demonstrated knowledge of review of safety cases and drafting of clinical narratives.
Strong verbal and written communication/presentation skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures.
High ethical & quality standards demonstrated through actions and communication.
Demonstrated ability to work independently and seek guidance, when needed.
Demonstrated ability to identify opportunities for continual improvement.
Must think critically and creatively.
Demonstrated experience working within a fast-paced, matrix environment.

LANGUAGE

Fluent English, French would be a plus

WORK ENVIRONMENT

Position based in Paris
Tele-working is possible 2 days a week
Full-time open-ended contract, starting as soon as possible (part-time also accepted if preferred)

REMUNERATION

to be negotiated + benefits in force in the company