Medical Affairs Clinical Research Advisor

• Job title: Medical Affairs Clinical Research Advisor
• Location: Lisbon (Portugal)

MISSION:

The main mission of the Medical Affairs Clinical Research Advisor (MACRA) in Portugal is to:

− Capture the R&D, Medical Affairs, and local Business Units needs, to ensure transversal alignment for the conduct of Clinical Trials in Portugal.

− Support the local R&D activity in Portugal in alignment with the Iberic CSU Cluster Head. The MACRA is the main Point of Contact in the Portuguese Affiliate for any clinical trial related activity with:

- Iberic CSU Leadership Team

- CSU Medical Advisors

- Clinical Project Leaders (CPL)

- Site Partnership Manager (SPM)

- CTA Regulatory Manager (CTARM)

- Any other CSU team member, as needed

− The MACRA is a key person which represents Sanofi R&D in front of external stakeholders in Portugal

− Ensure the traceability of the R&D investments performed in Portugal

RESPONSIBILITIES:

Medical Affairs, Business Units, and supporting the CSU functions

- Regulatory activities:

- Be the contact person with Iberic Cluster CTARM

- Responsible for updating/ allerting the CTARM on any new Regulatory requirement for Clinical Trial (CT) submission to Health Authority (INFARMED/Central Ethics Committee (EC), when applicable.

- Participate in the regulatory/ ad hoc regulatory meetings aimed to review the status of studies conducted in Portugal

- Attendance to Set-up meetings of studies conducted in Portugal

- Interfacing with Health Authorities and Central Ethic Committee and being the bridge with the Iberic CTARM, when needed (e.g. for clarifications)

- Support the validation of glossary in Portugal (LRA for IP labels)

- Main contact for APIFARMA

- Taking part in the Pharmaceutical Association (APIFARMA) meetings related to Clinical Studies.

- Distributing the APIFARMA Newsletter as needed to the proper stakeholders.

- Clinical Trial Delivery:

- Being aligned with the CT priorities and committed targets, end to end (E2E).

- Attendance/ participation in Operational Feasibility Meetings

- Site Partnership Management activities:

- Acting as liaison/contact person with the Iberic Cluster SPM in Portugal

- Maintaining and actively contribute to the site identification list agreed with SPM and Medical Advisors and aligned with portfolio and country strategy

- In liaison with CSU CPL, support sites on requests and prompt resolutions to achieve Sanofi standards

- Develop a network of Sites and Investigators to ensure a relevant analysis of study feasibility and execution together with the Cluster Medical Advisors

- Financial Agreement activities:

- Acting as liaison/contact person with Contract Specialists and Legal Department for Clinical Studies

- Acting as liaison/contact person and supporting the CSU Quality Lead.

- Safety activities: Support Iberic Cluster Safety Lead

- IP activities: Support for local depot management

- Facilities / Archiving room: in alignment with facilities management, acting as liaison/contact person with the local PT team, as needed

- For R&D outsourced studies, contribute with key Sanofi stakeholders to ensure that CRO partners are properly leveraging and interacting with the participating sites

- Fully accountable for Portugal R&D invoicing in alignment with Finance controller and EU Alliance Manager:

- Launch Local PO in eBUY

- Ensure the vendor includes in the invoices all the information needed to be stated in the monthly fees bill: split per project, per phase or any other details or statements that are required

- Track Portugal invoices and validate them

- Gather and handle the necessary data and documentation related to the R&D investment to ensure E2E execution of the necessary processes, supporting the finance controller needs

- Support preparation of Tax Rebate audits

Medical Affairs activities:

- Ensures strong interaction with CSU Cluster, transversal Medical Affairs and Business Unit for KOLs management contributing to study execution

- Support the identification of the next generation of Investigators and KOLs

- Contribute to strategic interaction with Medical & Scientific departments for KOLs and expert’s management.

- Share regularly the study projects scheduled and the status of the studies within the affiliate.

- Participation in local key Medical Congresses, Symposiums, Product Launches

- Develop local awareness and education when Sanofi enters new therapeutic areas

KEY WORKING RELATIONSHIPS:

Hierarchic / Functional dependence: Medical Country Lead

- Internal: CSU Leadership team, Clinical Project Leaders, CSU Medical Advisors, Medical Leads & Medical Advisors, local Pharmacovigilance, Public Affairs and Advocacy Representative

- External: APIFARMA, Health Authorities (INFARMED and others), ECs, KOLs, potential investigators & investigational study sites, CROs, Scientific Societies, Patient Advocacy Groups and others

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS:

Background: LifeScience Degree is mandatory (Medicine; Pharmaceutical, or other)

Professional experience: minimum 4 years’ experience in Clinical Research is essential, trained on Good Clinical Practices. Mandatory, minimum two years’ experience in Clinical Studies Management. Experience in Medical affairs is a plus

Knowledge:

- Highly knowledgeable in Investigator site management, clinical trial operations, study development, EMA Regulations and ICH/GCP guidelines

- Understanding of study start up complexities, RBM and overall Sponsor /site dynamics

- ICH – GCP and regulatory and safety regulations (local and European). Local and Corporate SOPs

- Good knowledge of the pharmaceutical industry and healthcare systems within the country

- Solid scientific background

Language: (language and knowledge level): Portuguese native language, English Advanced fluent in written & spoken, some domain of Spanish language is a plus

COMPETENCY REQUIREMENTS:

-Good scientific communication skills

-Effective team communicator that promotes transversal collaboration and Team work spirit

-Strategic thinking & problem solving

-Team training

-Proactivity & accountability mindset

-Ability to set priorities

-Analytic & Accuracy ability

-Strong social and influencing skills

-Optimistic, committed, dynamic, organized and results driven

-Competencies PLAY TO WIN:

-Stretch to go beyond the level we have operated at up until now

-Act in the interest of our patients and customers

-Take action instead of waiting to be told what to do

-Put the interests of the organization ahead of my own or those of our team

Why choose us?

• Bring the miracles of science to life alongside a supportive, future-focused team.
• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare,

Pursue progress, discover extraordinary

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com