Coordenação de Pesquisa Clínica e Bioequivalência - Divisão de Farmacêuticos Estabelecidos (EPD) - São Paulo/ SP

     

JOB DESCRIPTION:

• Provide accurate planning assumptions (budget and timelines) for proposed clinical programs/studies

• Work on single country studies which include Phase III, IV, and complex BE studies.

• Also, can be assigned PMOS and IIS studies as needed

• Lead the operational feasibility assessment of proposed clinical studies

• Plan, execute and close approved clinical studies according to the agreed budget and timeline and in accordance with applicable internal and external standards (Abbott OEC, Policies and Quality System, ICH&GCP and local regulations)

• Coordinate Abbott internal disciplines (as chair of Abbott Clinical Study Team), CRO team and insourced staff where applicable

• Select CRO and/or insourced staff

• Apply Project Management tools within Abbott environment

• Ensure that the study plans reviewed and followed

• Lead Risk and Issue Management (where needed this can include contact with external stakeholders, e.g. Clinical Sites, Regulatory bodies, KOL).

• Perform Oversight on CRO, vendors and Abbott internal disciplines

• Report progress to Abbott the functional lead

• Safety reporting is completed as per the SOPs and plans

• Participate in update meetings with I&D, medical affairs team as needed

• Maintain budget for the assigned studies and support functional leads for overall budget management

• Ensure study and clinical sites are inspection ready. Support and participate in the preparation and execution of internal audit or external inspection, as well as the relevant CAPA afterward

• Foster a culture of continuous improvement in clinical study operations, including implementation of lessons learned

• May be assigned certain simple special projects to work upon

• Mentoring Role for CTAs.

• Support other activities as per local/regional requirements

Required Qualifications

• M. Pharm, /B Pharm/ MSc/BSc Medical, Pharmacy or life sciences degree (or equivalent)

• Ability to work in a complex cross-cultural environment, with stakeholders all around the world

• Advanced project management skills

• Ability to make effective decisions based on good science and data in compliance with regulatory requirements and risk assessments

• Excellent knowledge of development of pharmaceutical products

• Excellent communication skills

• Excellent clinical reasoning skills, with the ability to independently assess and conclude on published and in-house data related to pharmaceutical products and EPD’s therapeutic areas

• Excellent English language skills, particularly in written form

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The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Medical & Scientific Affairs

     

DIVISION:

EPD Established Pharma

        

LOCATION:

Brazil > Sao Paulo : Building 1

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

No

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Not Applicable