As the world's largest staffing and recruitment agency, we are dedicated to helping you find the ideal role that offers growth and development opportunities within the life sciences sector. One of our premier partnerships is with a healthcare company developing new technologies to advance early cancer detection.
The Medical Writer is part of the Clinical Science group and will collaborate with members of cross-functional teams to prepare high-quality regulatory documents and clinical study-related documents within agreed-upon timelines and project manage the document development process. This is a full-time contract position with a minimum contract length of 9 months.
location: Durham, North Carolina
job type: Contract
salary: $90 - 110 per hour
work hours: 9 to 5
education: Masters
responsibilities:
- Collaborates with cross-functional clinical teams to use document preparation and project management skills to develop, draft, manage review, edit and finalize clinical documents.
- Ensures accurate and consistent communication in clinical documents through standardization of formatting and writing based on internal style guidelines and standard operating procedures (SOPs).
- Demonstrates strong project management skills, including defining project scope, developing timelines, tracking milestones, and escalating risks, to efficiently manage the development, drafting, review, editing, and finalization of clinical documents for regulatory submissions and other communications
- Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed with guidance from the project lead
- Schedules and conducts project-related meetings including the preparation of pre-meeting agenda, key points for discussion, post-meeting minutes and action items
- Works closely with teams to set realistic timelines for deliverables, completes documents according to agreed-upon timelines and follows up with teams as needed to meet internal and external timeline commitments
- Tracks progress on projects and provides regular updates to project lead and cross-functional teams through written and verbal communication (including team meetings)
- Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
- Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and adhere to required formatting and style standards
qualifications:
- At minimum Bachelor degree or equivalent in medical-related or life science field; advanced degree preferred
- At least 3 years of medical writing experience, preferably for in vitro diagnostics (IVD); pharmaceutical, biologics or medical device experience also acceptable.
- Proficient with Zotero reference management software
- Additional qualifications (AMWA, EMWA, or RAC training; CMPP certification) preferred
- Ability to read, write and speak fluent English; excellent verbal and written communication skills
- Thorough knowledge of Medical Devices, GCP, ICH guidelines, and other US and international clinical regulatory requirements.
- Strong interpersonal communication (written and verbal), organizational and prioritization skills.
- Able to work effectively under a fast-paced and changing environment.
- Strong work ethic and demonstrated ability to deliver assignments on time.
- Proficient with office automation tools, such as Microsoft Office and the Google suite of applications
skills: CSR, GCP (Good Clinical Practice), CTD Structure, ICH Regulations
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 health, an incentive and recognition program, and 401K contribution (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.
