This is an exceptional opportunity for a detail-oriented professional to join a leading organization in the healthcare industry as a Remote Medical Writer II. You'll play a critical role in ensuring the integrity and accuracy of clinical regulatory documentation, directly impacting both domestic and international regulatory submissions. The work you do will support groundbreaking developments, and the company's commitment to innovation is evident in its cutting-edge facilities. This offers the chance to operate with limited oversight, take ownership of critical quality control processes, and collaborate with experienced cross-functional teams, making it an ideal step for career growth.
location: Telecommute
job type: Contract
salary: $40.00 - 47.23 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Defining the scope of quality control activities with document authors and identifying all required source documents and data.
- Conducting independent quality control reviews of documents against source data and applicable checklists to ensure accurate results.
- Ensuring quality control documentation is complete and accurately uploaded to the master file per established business processes.
- Interacting daily with medical writers and/or medical writing managers, and communicating with applicable cross-functional areas.
- Maintaining strong knowledge of clinical regulatory documents and relevant business processes.
- Preparing and proofreading technical documents to support both domestic and international regulatory submissions.
- Incorporating text, graphs, charts, tables, and statistical analysis into product submissions.
qualifications:
Required Skills & Experience
- Bachelor's degree.
- 2-3 years of relevant industry experience in quality control/review of clinical regulatory documents or related areas (e.g., quality assurance, clinical research, drug development, regulatory).
- Excellent knowledge of the organization and content of clinical documents and eCTD structure.
- Superior attention to detail and the ability to prioritize multiple tasks and projects effectively.
- Excellent oral/written communication and interpersonal skills.
- Experience in working with collaborative cross-functional teams.
- Bachelor's degree in Science, English, or Communication.
- Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
- Strong analytical/critical thinking and conflict management skills.
skills: Proofreading, Common Technical Document (CTD), Electronic Common Technical Document (eCTD)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
