Spain - Senior Clinical Research Scientist

Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of Central Nervous System disorders (CNS). We have a direct presence in 18 countries and plan further geographic expansion as part of our strategy to strengthen our position as a European leader in CNS treatments.With our focus on CNS, Neuraxpharm develops and commercializes value added medicines, standard generics and consumer healthcare products, e.g. nutraceuticals and probiotics, and is continuously striving to offer a wide range of effective, high quality and affordable CNS treatments in Europe.Present with our products in more than 50 countries, Neuraxpharm also manufactures pharmaceutical forms and active pharmaceutical ingredientsin our own manufacturing sites in Spain. With more than 900 professionals, Neuraxpharm has a unique understanding of the CNS market built over 35 years.Neuraxpharm is searching a vacancy based in Sant Joan Despí:
Senior Clinical Research Scientist (Clinical Development)
He/she will be responsible to correctly plan, designand monitor the different tasks related to the execution and oversight of clinical trials and bioequivalence studies, following current national and international regulations, as well as the company's internal SOPs, with the final purpose to obtain the clinical study reports and the corresponding CTD dossier modules that granted the registration of a drug product.

**Major accountabilities**:

- Design, contract, oversightand monitor clinical and pre-clinical trials.
- Identify, select and hire contract research organizations, vendors and/or public sitesto performclinical studies.
- Request the pertinent authorizations to the applicable Health Authorities to perform clinical studies, as well as the corresponding certificates and all the required documentation.
- Inform and interact with the Pharmacological Development Unit to obtain the medication from the clinical trials of the company’s affiliates and their subsequent return, when applicable.
- Evaluate the consistency of the results of clinical trials. File all the generated documentationin association with a clinical trial performance.
- Update and/or prepare newSOPs (PNTs)of the Department.
- Control the evolution and follow-up of the clinical trialand alert about possible incidents.
- Act as validinterlocutor with the Clinical Trials Quality Assurance Unit and respond to audit reports.
- Prepare and review of documents related to clinical trials: synopsis, clinical study protocols and amendments, informed consent forms, CRFs, clinical study reports, analytical and statistical reports, confidentiality agreements, financing contracts and other relevant documents that apply.
- Prepare Module 5 of the CTDdossierpursuingdrug registration.
- Review Sections2.7.3, 2.7.4 and 2.5 of the CTD dossier.
- Provide technical support to the RegulatoryDepartment in its relationship with the Health Authorities during the evaluation of registration files.

**Requirements**:

- Bachelor's degree in Health Sciences, preferably Pharmacy, Biology or Biochemistry.Preferably Master's Degree in Clinical Trials, Clinical Researchor Experimental Biology.
- Minimum experience of 2 years in management, coordination and conduct of clinical trials OR 4-5 years developing tasks as a senior CRA (Clinical Research Associate) with complete autonomy.
- Experience in the field of generic specialties and clinical bioequivalence studies is extremely valued.Clinical Operation Overview experience in therapeutic advanced clinical trials will also be valued.
- We are looking for anorganized and methodical professional, with good communication skills. Results oriented, initiative and proactivity, planningand analytical thinkingskills.
- Knowledge of bioequivalence studies procedures and the applicable regulation in different territoriesis a must.
- English proficiency is a must.

**Benefits**:

- Individual Professional development in a leading European pharmaceutical company withan ambitious international growth strategy.
- Economic conditions will be according to the experience and skills provided
- A motivated and committed environment based on a diverse and inclusive culture.
- A specialized team focused on our core activity: Improving our patients’ lives.