Associate Scientific Writer - Medical Devices

Applied Medical; Rancho Santa Margarita (CA); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Competitive compensation

Comprehensive benefits package

Education reimbursement program

401(k) program with employer match

Job summary

A medical device company in Rancho Santa Margarita is seeking an Associate Clinical Writer to develop scientific protocols and reports. This role demands strong writing and analytical skills, alongside collaborative teamwork. Candidates should have a relevant advanced degree and experience in literature searches. The position offers competitive compensation between $70,000 and $80,000 per year, along with a comprehensive benefits package.

Qualifications

• Experience in conducting focused literature searches on PubMed, Embase, or similar databases.
• Ability to formulate reports and present findings.
• Effective written and oral communication skills.

Responsibilities

• Develop and complete scientific protocols and reports for medical devices.
• Conduct reviews of post-market data and incorporate findings into reports.
• Collaborate with cross-functional teams to analyze clinical data.

Skills

Critical Thinking

Writing Skills

Communication

Data mining and analysis

Education

Bachelor’s or Advanced degree in a scientific field

Tools

Microsoft Office

Job description

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.

Position Description

Collaboration is a fundamental part of our organization's culture and is essential to our continued success. The successful candidate for this position is expected to work fully on-site, enabling engagement with colleagues and cross-functional initiatives. The ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.

As an Associate Clinical Writer, you will work within the Clinical Affairs team. The Associate Clinical Writer's primary responsibilities are developing and completing scientific protocols and reports, including Clinical Evaluations and Post Market Clinical Feedback as part of design validations for medical devices to support product registrations internationally. You will conduct reviews of post-market data, such as complaints and feedback, to incorporate relevant data and analysis into reports.

Key Responsibilities

• Critical Thinking: You will need to be able to critically evaluate scientific literature and research findings and apply this knowledge to your work. This involves asking questions, identifying gaps in the research, and synthesizing information from multiple sources.
• Writing Skills: You will be responsible for conducting thorough literature searches to identify relevant studies, systematic reviews, and meta-analyses that inform your writing. You will also be responsible for creating and maintaining job aids and work instructions for the preparation and maintenance of compliant medical writing deliverables.
• Communication: You will be responsible to manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. You will also be expected to collaborate with cross-functional teams to develop new and insightful analytics to collect and analyze clinical data.

Position Requirements

This position requires the following skills and attributes:

• Bachelor’s or Advanced degree in a scientific field (MS, Ph.D., MD, or Pharm. D.)
• Experience in conducting focused literature searches on PubMed, Embase or other similar literature databases
• Data mining and analysis
• Ability to formulate reports and present findings
• Effective written and oral communication skills
• Ability to collaborate in a team environment
• Project management and organizational skills
• Strong familiarity with Microsoft Office

Preferred

The following skills and attributes are preferred:

• 1-2 years of experience in the medical device/pharmaceutical field or 1+ years of research with professor
• Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
• Experience performing statistical analysis with statistical programs
• Ability to prioritize and manage multiple projects
• Data analytic publication experience or literature author publication experience

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Please note: This role is internally titled 'Associate Clinical Writer'. Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities.

Benefits

• Competitive compensation range: $70,000 - $80,000 / year (California).
• Comprehensive benefits package.
• Training and mentorship opportunities.
• On-campus wellness activities.
• Education reimbursement program.
• 401(k) program with discretionary employer match.
• Generous vacation accrual and paid holiday schedule.

Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.

Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.

All compensation and benefits are subject to plan documents and written agreements.

Equal Opportunity Employer

Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.