Medical Writer

Job#: 2042861

Job Description:

Apex Systems is seeking a Medical Writer consultant to join their remote clinical research team! This project is expected to last 5 months!
 

Job Title: Clinical Data Analyst/Medical Writer
 

Duties:

• Analyze, interpret, and present biopharmaceutical and device data results, medical/clinical study findings, and clinical data.
• Author clinical study reports, NDA and health authority summary presentations, regulatory documents, and medical journal abstracts.
• Prepare scientific and regulatory documents, including but not limited to IND, NDA, BLA, MAA, PMA/510k, Annual Reports, Amendments, Supplements, Investigator’s Brochures, and protocols.

Technical Skills:

• 4-8 years of experience.
• Proven experience performing literature reviews, analyzing data, and communicating outputs.
• Experience writing scientific documents for regulatory or journal submissions.
• Experience presenting scientific/clinical evidence in written and oral formats to cross-functional teams.
• Demonstrated ability to build positive, constructive relationships with cross-functional team members.

Core Skills:

• Excellent scientific writing skills.
• Experience creating and performing literature searches.
• Proficient in Microsoft Word, Excel, and PowerPoint.
• Strong data extraction and analysis skills.
• Proactive with a sense of urgency in managing job responsibilities.
• Self-motivated and able to work independently.
• Analytical thinking and inquisitive mindset.
• Ability and desire to develop good working relationships internally and externally.

Education:

• BA, BS, or equivalent experience in a related field.
• Advanced Degree preferred.

Skills and Experience:

• Writing Skills
• Excel
• NDA

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.