Ihre Aufgaben- Lead a team of motivated Medical Writers in the area of medical devices and medicinal products
- Define and implement with HR an effective staff training plan, including supervision, and mentoring of Medical Writers
- Resource planning and recruitment to achieve all company targets, maintaining a climate to attract, retain and motivate top quality personnel
- Motivate staff to meet or surpass contractual and/or internal delivery targets and KPIs
- Act as Lead of Medical Writer’s responsibilities in projects, including preparation, planning, coordination, and supervision of activities falling under the responsibility of the medical writer group (including supervision to keep the timelines)
- Ensuring critical review of documents (such as Clinical Development Plan, Clinical Evaluation Plan, Clinical Evaluation Report, Post Market Clinical Follow Up Plan, Post Market Clinical Follow Up Report, Summary of Safety and Clinical Performance, Investigator’s Brochure, Risk Analysis)
- Preparation of documents for regulatory submission, within a team environment and ensuring process, content, and submission/document planning expertise
- Coordination of collaboration with external partners (e.g. contract medical writers) and internal teams
- Creation and maintenance of SOPs and forms and their respective training, including development of appropriate workflows relevant to medical writing activities
- Active role in improvement of CROMA processes and implementation of agreed improvement steps
- Conduct of internal trainings
| Ihr Profil- Track record of developing/growing operational capabilities and processes and implementing improvements
- Strong adherence to project timelines and regulatory requirements
- Scientific degree, preferred in life sciences
- Demonstrated experience in creation and review of Clinical Development Plan, Clinical Evaluation Plan, Clinical Evaluation Report, Post Market Clinical Follow Up Plan, Post Market Clinical Follow Up Report, Summary of Safety and Clinical Performance, Investigator’s Brochure
- Knowledge of the product registration processes according European and US regulatory requirements (such as 93/42/EEC, 2017/745/EU and FDA/CFR)
- 7 years + experience within a senior medical writer role within the medical device area
- 5 years + demonstrated experience of line management and team leadership
- Familiarity with relevant norms, standards, codes of practice and guidelines (e.g. 93/42/EEC, 2017/745/EU, ISO 14155, ICH-GCP, FDA/CFR)
- Fluency in English required, German is a Plus (written and spoken)
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