Senior Medical Writer (m/f/d)

Senior Medical Writer (m/f/d)

Job Description

Senior Medical Writer – Hospital Patient Monitoring (Böblingen, Germany)

The Senior Medical Writer will be responsible for authoring and maintaining clinical and post-market documentation (CEPs, CERs, PMCFPs, and PMCFRs). 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).

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, and literature review processes. Must also remain current with regulatory requirements as they relate to clinical evaluations and contributions to regulatory documents.
• Interaction with cross-functional teams to ensure compliance of the clinical evaluation for new products requiring CE Mark and ensuring compliance with internal policies and procedures.
• Manage timelines and communication to ensure deliverables and milestones are met; comply with Good Documentation Practices to ensure quality and accuracy of document content and format; and prepare for and participate in audits, as needed.
• Provide mentorship and assistance to other medical writers on the team.
• Participate in audits and respond to feedback from notified bodies and regulatory agencies.

You\’re the right fit:

• Experience in clinical research or healthcare is strongly preferred; knowledge of bedside patient monitoring is preferred. Strong experience and skill in performing systematic searches of the medical/scientific literature using tools including Embase and PubMed, highly skilled with data extraction and related tools (e.g., Distiller, Zotero, EndNote), and advanced knowledge and experience with international regulatory requirements, standards, and guidance (EU 2017/745, MEDDEV 2.7.1 Rev 4, ISO 13485, ISO 14155, ISO 14971, applicable MDCGs).
• High comfortability and experience working within GDP and knowledge of relevant writing styles (e.g., AMA) and good publication practices (e.g., ICMJE). Strong knowledge of clinical research methodology, including study design, outcomes and measures, and biostatistics is required; strong ability to identify, mitigate, and escalate risks, and strong ability to prioritize and meet multiple project deadlines. Excellent written English and oral communications skills with strong attention to detail related to consistency, grammar, syntax, and accuracy.
• A minimum of BS/BA in a scientific or medical discipline with at least 7 years of experience in clinical evaluation report writing in the medical device industry OR an advanced degree (MS, MA, MPH, PharmD, PhD, MD) strongly preferred with at least 2 years of direct experience in clinical evaluation report writing in the medical device industry.
• Ability to successfully perform the following minimum Physical, Cognitive, and Environmental job requirements with or without accommodation for this position.
• Self-starter with an ability to learn quickly and self-educate on different medical device products and procedures; strong project/timeline management skills and organizational skills, as well as a demonstrated ability to work and communicate effectively in a team environment including leading discussions and presenting to internal business and regulatory stakeholders.

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