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**Title**:
Director Medical Affairs

**Company**:
Ipsen Pharma (SAS)

**Position**

Job title: Medical Affairs Director

Department: Medical Affairs

Line Manager (name, job title): General Manager

Location of the role: Bogotá, Colombia

**Purpose of the position**

The Country Medical Director is accountable to define and execute the overall medical affairs strategy and operational plan for the country within the Global medical affairs framework adapted when needed to local imperatives through high medical expertise, while complying with all laws and codes, by adhering to high ethical and quality standards, with the goal of generating added value for all patients and customers, and thereby contributing to the business success of the company.

The Country Medical Director has a major leadership role sharings responsibility for the development and execution of the Country strategic and operational plans as a member of the Country Management Team and as Head of Medical Affairs team.

**Main responsibilities and tasks**

**Define the strategy for Medical Affairs locally and execute it**:

- Create and implement strategic and operational plans in the country, in line with the mission, strategy and values of the Ipsen Group, and thus achieving Global Medical Affairs and Local targets
- Secure the successful execution of the medical strategy in line and consultation with the responsible interdisciplinary teams
- Overall responsible for resource allocation and budget control for the Medical Affairs Department, and corrective measures as necessary
- Perform due medical diligence, ensuring that Ipsen products retain a positive benefit / risk ratio, unconditionally placing patient safety in the foreground
- Ensure proper life-cycle management for all new and existing products




- Represent the country internally at the Integral Medical Affairs level

**Manage the daily Medical Affairs activities**:

- Provide clinical expert opinions, and where appropriate training on products and therapies for internal and external customers
- Coordinate and supervise technical promotional information, clinical studies and training to commercial representatives ensuring the compliance with our own SOPs, GCP and applicable law.
- Oversee the approval of Medical Education grants process.
- Oversee Drug Safety activities in the country
- Ensure that all products are supervised by experts, and that the interdisciplinary teams get the appropriate medical input
- Ensure that all reasonable and necessary medical measures are planned and executed in order to add value for patients and customers, and secure and build business success in the corresponding indications
- Updating and maintaining current clinical knowledge and experience
- Activities in Medical Affairs include but are not limited to medical information, medical education, data generation, medical publication and representation, patient safety, KOL management

**Oversee local Clinical Operations & Execution**:

- Identify and implement post-approval non-registration Clinical Sponsored Studies work as well as Investigator Initiated Studies aligned with Global Medical Affairs and Asset Data generation strategy.
- Ensuring the timely, legally compliant,



high-quality performance of all types of studies (including Ipsen studies, national, international, interventional, non-interventional, prospective and retrospective studies, PASS, PAES, ISS), within the available and agreed budgets, in consultation with the respective teams and in line with the prescribed corporate strategy. Develop strategies where appropriate to leverage RWD and develop relevant RWE to support local and global objectives including but not limited to potential label extensions and market access.
- Taking suitable measures in the event of deviations.

**Create a high performing team to execute the local Medical Affairs strategy**:

- Promote a performance-oriented, customer-focused environment through the development, motivation and effective leadership of the Medical Team
- Manage a medical Team of office based Medical Advisors (Medical Affairs Managers) and Medical Information and field-based MSL and MSL Manager
- Recruit highly qualified team members with clearly defined roles and corresponding skillsets
- Set-up and follow carefully clear objectives and responsibilities for the team
- Support of efficiency and effectiveness by implementing appropriate management processes, and sharing ideas and best practices

**Represent Ipsen with external partners / authorities**:

- Represent the Country Medical Team and Ipsen’s medical position to external opinion leaders, medical organizations, Patient organizations and authorities
- Cooperate with colleagues from other departments, in order to build proactive, effective cross-function communication and build possible collaborations externally.
- Provide medical-scientific point of contact for Key Thought Leaders (KTL).
- Represent Ipsen locally with partner firms.

**Expe

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📌 Director Medical Affairs (Bogotá)
🏢 IPSEN
📍 Bogotá