CAREERS AT ECLEVAR
ECLEVAR believes in recognizing, promoting and rewarding our strong performers. Career progression is based on your personal performance and contribution. With positive results, you’re given the freedom to shape your own career path within the firm. Our firm’s long-term success is rooted in our ability to adapt and cultivate the next generation of visionary and innovative leaders.
ECLEVAR’ team structure has seven levels, each with distinct roles aimed at achieving the most effective blend of research skills, analytical capabilities, industry and consulting experience: Analyst, Associate, Senior Associate, Manager, Senior Manager, Director and Managing Director.
One can enter our career path at any point assuming you have the requisite skills, experience, knowledge and prior performance in life sciences and/or consulting.
The Clinical/Medical Report Writer will primarily focus and be responsible for review and research of medical and scientific literature in order to author Clinical Evaluation Reports (CERs) and well as maintain and update existing CERs. In addition, the Clinical/Medical Report Writer may contribute toward or author other technical documents that support clinical and regulatory efforts of the company.
- Authors Clinical Evaluation Reports (CERs) including clinical section of regulatory authority requests.
- Maintains/updates existing company CERs according to internal SOPs.
- Lead internal team review and approval for Clinical Evaluation Reports.
- Communicates/collaborates with outside consultants in the development of CERs when necessary.
- Contributes toward post-market clinical safety and risk management programs as requested.
- Provides product guidance and expertise to the Clinical Affairs Associate to help with conducting literature searches on products/product families.
- Critically appraises scientific literature and writes summaries for articles, products and surgical procedures.
- Coordinates the efforts of cross-functional teams to produce scientifically accurate, high-quality technical documents.
- Remains current with regulatory requirements as they relate to clinical evaluations and clinical contributions to regulatory documents.
- Manages timelines and communication to ensure deliverables and milestones are met.
- Prepares for and participates in audits as needed.
- Interacts with internal and international teams (engineering/marketing/regulatory) to define the plan and strategy for development of the Clinical Evaluation Reports for new products requiring CE Mark.
- Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes and the ability to keep abreast of current literature.
- Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.
- Assists with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on clinical needs.
- Ensures compliance with corporate (e.g. SOPs) and regulatory requirements (e.g. GCP and US and OUS guidelines).
- Other duties as assigned
- Prepares basic statistical analysis reports as needed.
- Performs periodic reviews of risk documentation and product labeling; ensure appropriate updates are implemented.
This is a full-time position with typical business hours. It may reasonably require additional hours during the week and weekend; specific requirements will be determined with Manager. Occasional remote work may be allowed.
- Minimum of Masters Degree required
- Minimum of 5 years of medical writing experience.
- Experience with developing CERs per MEDDEV 2.7.1 Rev 4.
- Experience and skill performing medical literature searches (PubMed, Google Scholar, etc.)
- Excellent written communications skills- strong attention to detail related to consistency, grammar, syntax, and accuracy
- Ability to identify critical information needs and identify roles/individuals to involve for decision making within clinical evaluation assessment and report development
- Basic project/timeline management skills and organizational skills
- Ability to prioritize and manage multiple projects
- Self-starter attitude with ability to learn quickly and self-educate on different medical device products and procedures
- Strong familiarity with Microsoft Office
- Experience in orthopedics/podiatry/spine preferred
Twelve (12) months ago, the EU Commission published a Notice to Stakeholders, “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products,”Read More..
JOIN ECLEVAR AT MEDTEC JAPAN
ECLEVAR invites you to meet with us at MedTec Japan in Tokyo, Japan on 18-20 April.
EXCEPTIONAL CAREERS – INSPIRING EXPERIENCES
Working at ECLEVAR will allow you to apply your expertise and knowledge to make a difference in the lives of others. Curious about our opportunities? Read More..