Senior Medical Writer (m/f/d)

Das ist der Job

You will also contribute to Risk Management and Post-Market Surveillance function efforts, as needed.

Darum lohnt es sich

This person may also contribute to authoring other technical documents that support Clinical, Regulatory, Risk Management, or Post-Market Surveillance efforts (e.g., Clinical Evidence Strategies, Benefit-Risk Determinations, PSURs).

Interaction with cross-functional teams to ensure compliance of the clinical Job Title Senior Medical Writer - Hospital Patient Monitoring (Boblingen Germany) Job Description The Senior Medical Writer will be responsible for authoring and maintaining clinical and post-market documentation (CEPs, CERs, PMCFPs, and PMCFRs).

Your role: Contributing to and authoring clinical evaluation deliverables for new and sustaining products (CEPs, CERs, and PMCFP/Rs) according to MEDDEV 2.7.1, Rev. 4 and compliant with EU MDR.

Responsible for compiling, appraising/analyzing, and synthesizing multiple types and sources of data (e.g., clinical study results, post-market surveillance data, risk assessments, published literature) to evaluate product safety and performance and to identify potential evidence gaps.

Acquire/maintain thorough knowledge of business unit products, competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep current with relevant literature.

Must also remain current with regulatory requirements as they relate to clinical evaluations and contributions to regulatory documents.