Clinical Science Medical Expert — MAP/NPU & Regulatory

medac Gesellschaft für klinische Spezialpräparate mbH; Deutschland; Ibrido; USD 100.000 - 130.000; Tempo pieno

Vantaggi offerti da questo lavoro

Flexible working hours

30 annual vacation days

Success-based bonuses

Individual training opportunities

Funded pension scheme

Counselling services

Descrizione del lavoro

medac pharma production GmbH is seeking a Medical Expert to lead Managed Access Programs and ensure quality in regulatory documentation. The ideal candidate possesses a Medical Doctor degree and has a strong background in drug development, particularly in cell therapies.

This role requires outstanding analytical skills and the ability to collaborate with various stakeholders in a scientific context. Attractive benefits include flexible hours, training opportunities, and a robust pension scheme.

Competenze

• Medical Doctor required with experience in cell therapies and clinical practice.
• Expertise in regulatory submissions and benefit-risk assessments.
• Fluent in English, German is a plus.

Mansioni

• Lead medac’s Managed Access Programs and evaluate clinical requests.
• Ensure high-quality clinical and regulatory documentation.
• Interface with stakeholders on access strategies and regulatory processes.

Conoscenze

Medical Doctor

Deep understanding of global drug development

Strong background in Phase I-III trials

Exceptional medical writing and storytelling

Strong analytical thinking

Fluent English

Some German preferred

Formazione

Medical Doctor degree

Descrizione del lavoro

About the Role

Leads and evaluates medac’s Managed Access Programs (MAP) and Named Patient Use (NPU) requests from a clinical and ethical perspective, ensuring robust benefit–risk assessments and patient-focused decision-making.
Hands-on Medical Expert responsible for executing clinical-scientific activities across the product lifecycle, focussed on the development of high-quality regulatory documentation (CTD) and support of global submissions and lifecycle management.
Acts as a cross-functional clinical partner, translating clinical data into consistent scientific messaging and supporting decision-making across Clinical Science. Brings experience in innovative therapies, including cell therapies, within evolving clinical and regulatory environments.

Key Responsibilities

• Lead and evaluate medac’s Managed Access Programme and Named Patient Use (NPU) requests from a clinical and ethical perspective

• Ensure robust benefit–risk justification, regulatory alignment and high-quality documentation

• Interface with regulatory, legal, Pharmacovigilance and commercial stakeholders on access strategies

• Author, review and lead high-quality clinical and regulatory documents (CTD), including Clinical Overview & Clinical Summary, Clinical Expert Statements, Risk Management Plans (RMPs), SmPC, CCDS, PIL, PSURs / DSURs and other Lifecycle documents

• Ensure scientific consistency, quality across submissions and lifecycle documentation, including for complex products such as cell therapies / ATMPs

• Contribute to regulatory strategy documents, briefing packages and support global regulatory interactions, including scientific advice procedures and Health Authority meetings

Your Profile

• Medical Doctor required

• Deep understanding of global drug development and regulatory frameworks

• Strong background in Phase I-III trials, medical monitoring and clinical practice

• Demonstrated experience in cell therapies /ATMPs (highly preferred), Managed Access Programs/Named Patient Use, Regulatory submission (CTD authoring, Module 2)

• Therapeutic expertise in oncology, hematology, rheumatology or immunology

• Exceptional storytelling capability

• Strong analytical thinking and benefit-risk assessment skills

• Ability to translate complex science into clear strategic recommendations

• Language: Fluent English, some German preferred

Our employees are our greatest asset. And to show our appreciation, we offer attractive benefits:

• Your work-life balance is important to us. We offer flexible working hours with the option of working a proportion of those hours remotely, 30 annual vacation days and an excellent cafeteria

• Attractive salaries and success-based bonuses for all medac employees

• Individual training opportunities: Our medac academy offers a wide range of programmes including leadership training, coaching essentials and language classes

• A funded pension scheme and other social benefits

• We care for our employees beyond the workplace and provide advice on caring for elderly relatives as well as offering counselling

• We promote sports and activities to improve our employees’ health