Senior Medical Writer — Clinical Reporting Lead

Novo Nordisk A/S; Søborg; A distancia; DKK 651.000 - 957.000; Jornada completa

Descripción de la vacante

Novo Nordisk A/S in Søborg seeks a permanent Medical Writing professional to drive the preparation of complex regulatory and clinical documents and act as a project manager. You will lead tasks across cross-functional teams to meet tight timelines and ensure scientific rigor.

Responsibilities include planning protocols, ICFs, IBs, clinical summaries, and paediatric plans, plus developing briefing packages and responding to health authority questions. Collaboration across departments is essential.

Formación

• Master’s degree in natural sciences, MSc., MSc. Pharm. or equivalent, with pharma industry experience preferred.
• Track record driving complex tasks from start to end with multidisciplinary stakeholders.
• High level of scientific communication tailored to diverse objectives.
• Ability to improve processes and promote sharing of best practices.
• Strong understanding of clinical development, regulatory processes, and clinical documents.
• Full proficiency in spoken and written English.

Responsabilidades

• Plan, develop, and oversee regulatory and clinical documents in line with timelines.
• Prepare study protocols, informed consent forms, investigator’s brochures, clinical summaries, and paediatric plans.
• Develop briefing packages and responses to health authority questions.
• Represent Clinical Reporting in cross-functional project teams and provide guidance on planning and data presentation.
• Collaborate across Medical & Science, Regulatory Affairs, Clinical Operations, Biostatistics, and Pharmacovigilance.

Conocimientos

Project management

Scientific communication

Stakeholder management

English proficiency

Planning and coordination

Educación

Master’s degree in natural sciences

PhD preferred

Descripción del empleo

Novo Nordisk A/S in Søborg seeks a permanent Medical Writing professional to drive the preparation of complex regulatory and clinical documents and act as a project manager. You will lead tasks across cross-functional teams to meet tight timelines and ensure scientific rigor.

Responsibilities include planning protocols, ICFs, IBs, clinical summaries, and paediatric plans, plus developing briefing packages and responding to health authority questions. Collaboration across departments is essential.