Senior Manager Scientific Affairs (m/f/d)
Assures availability and oversight of professional medical writing expertise to enable clinical document development like study protocols, briefing books, submissions as well as rapid response team readiness.
Serves as the central point of contact for medical writing vendors and regulatory affairs and coordinates activities within the clinical team.
Prepares draft concept sheets and outlines of submission dossier storylines.
Builds and develops together with the Senior Director center of excellence for clinical trial disclosure, clinical modules, agency responses and literature.
Stays abreast of professional information and technology to augment expertise in the clinical development area with focus on biosimilars.
Ensures adherence to GCP and pharmacovigilance standards related to clinical development administrator role at clinicaltrials.gov for the biosimilar business and trials coordinator at other registries.
Prepares, oversees budget and invoices for clinical medical writing activities Supports medical writing vendor selection in all aspects as needed (RFPs, bid processes etc).
Education and work experience:
- Natural science education within biology, biotechnology, medical or similar.
- Bachelor level as minimum, PhD is an advantage.
- At least 5 years of clinical development including medical writing experience in the pharmaceutical industry, academia, or equivalent.
- Experience with briefing books, dossier preparation etc. is desired.
Job Specific Competencies & Skills:
- Ability to identify the key elements necessary for the clinical parts of a dossier and essential clinical documents.
- Ability to work and cooperate in cross-functional global teams in a matrix environment.
- Ability to interact with external and internal stakeholders to understand clinical document frameworks for regulatory agencies.
- Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials.
- Knowledge in overseeing clinical writing activities including clinical trial disclosure according to expected format and quality Ideally experience with both, FDA and EMA dossiers.
Excellent oral and written English communication skills.
At least 5 years of clinical development including medical writing experience in the pharmaceutical industry, academia, or equivalent. Experience with briefing books, dossier preparation etc. is desired.