The role involves authoring and gaining approval for scientific and regulatory submission documents that comply with global and local standards
Job Summary
The role involves authoring and gaining approval for scientific and regulatory submission documents that comply with global and local standards.
Candidates will serve as a functional area lead on product teams, managing writing activities for local product submissions including new drug applications.
The position requires maintaining key business relationships with cross-functional team members while adhering to complex standard operating procedures.
Matching Summary
The role involves authoring and gaining approval for scientific and regulatory submission documents that comply with global and local standards.
Skills & Requirements
Must-have
Author regulatory submission documents
Native language written communication skills
Upper-intermediate business English proficiency
Knowledge of clinical development process
Ability to analyze scientific data
Nice-to-have
Mentoring junior regulatory writers
Negotiation and persuasion skills
Experience with CRO and freelance writers
Self-starter drive to achieve results
Participation in cross-departmental initiatives
Key Requirements
Doctorate degree OR Master's degree with 3 years experience
Bachelor's degree with 5 years directly related experience
5+ years experience in medical writing within Biotech/Pharma industry