Regulatory Writer

On-location or Remote

As NMD Pharma continues its growth trajectory, we are seeking a Regulatory Writer, who will contribute to the development of complex clinical and regulatory documents for health authority submissions including, but not limited to, investigator brochures (IBs), health authority meeting packages/briefing books, module 2 summaries, module 5 documents, safety narratives, annual reports (e.g. DSURs), pediatric investigation or study plans, clinical story book document and other key clinical and regulatory documents.

Preferred Work Locations:

The primary locations for this position are Denmark (Aarhus or Copenhagen) or the United States (East coast). A secondary option is remote work from a home base within Europe.

As this is a global role, some travel will be required, along with schedule flexibility to accommodate collaboration with team members across different time zones.

Key Responsibilities

• Lead and individually contribute to the regulatory writing activities for a variety of clinical and regulatory documents.
• Responsible for ensuring the preparation of high-quality clinical/regulatory documents.
• Draft and manage documents that are well-organized, accurate, consistent, and in compliance with applicable company SOPs and regulations.
• Effectively manage and communicate document timelines (authoring, review, comment resolution, QC, and finalization).
• Facilitate standardization of documents using document templates and company style guides to ensure the quality and consistency of documentation across programs.
• Collaborate with project and development teams, including regulatory affairs, project management, clinical/medical, nonclinical, clinical operations, CMC, biostatisticians, quality assurance, and data management, to ensure project deadlines are met by providing content development support, research, and editing functions for the programs.
• Remain up-to-date with current medical writing practices and regulatory knowledge, including Good Clinical Practice (GCP), along with developments and advances in clinical drug development for neuromuscular disorders.

Your background

• Bachelor's degree in a scientific, medical, or clinical discipline or related field is required; Master’s or PhD preferred.
• Minimum of 5 years of pharmaceutical/biotechnology-related medical writing experience is required.
• Extensive understanding and experience leading teams through the delivery of clinical Module 2 and Module 5 documents is required.
• Familiarity with FDA and ICH guidelines for clinical reporting.
• Experience leading and managing Regulatory Medical Writing submissions (major global marketing applications) in a matrixed setting, including working with external partners.
• eCTD development, publishing, and submission experience preferred.
• Therapeutic experience in neuromuscular diseases is advantageous.
• Familiarity with pharmacovigilance documents is preferred.

Skills and Mindset

• Effective, oral, written and cross-cultural communication skills (English).
• Demonstrate organizational awareness, strategic thinking/agility, and innovation skills.
• Understanding of scientific methodology, with the ability to understand clinical development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission for drugs.
• Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international processes related to document preparation and production.
• Ability to proofread documents for compliance with internal and external guidance documents.
• Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion.
• Ability to work autonomously, as well as collaboratively in a team.
• Excellent time management skills and a proven ability to work on multiple projects at any given time.

Benefits:

We offer competitive salary packages and the opportunity for professional growth in a collaborative and innovative work environment. This role can be structured as a full-time or part-time employment. Let us know your preference.

Want to learn more?

For further information, please contact Maja Nielsen at mbn@nmdpharma.com. Send your application and CV via the link below. To ensure GDPR compliance only applications received via the link will be reviewed. We will review and interview on an ongoing basis.

Apply with QuickApply on Jobindex.