Medical Writer

**We are Growing** Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of.

Biorasi is looking for top performers who are as passionate about clinical research as we are - clinical trial veterans and industry newcomers who will thrive in our fast-paced environment and help us drive new therapies to patients. Here is your chance to become a vital part of a growing global company in the expanding clinical research industry.

Start your career journey at Biorasi today with our newest opportunity
- **Medical Writer**
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**Overview**
- We are international: Our headquarters is in Aventura, Florida. Other locations are Germany, India, Russia, and Ukraine.
- Our work culture includes: teamwork, hands-on mentality, flexibility, and open communication.
- Development and worklife balance: We want our employees to develop personally as well as professionally

**Your Responsibilities**
- Serve as a back-up primary contact for sponsors, vendors, and project team for Medical Writing Issues.
- Assist in scope of work, timeline, deliverables, milestones, and workflow for responsible projects.
- Assist in design and development of clinical study reports (CSRs), Protocols, Investigator Brochures (IBs) Plans and regulatory documents
- Prepares independently, written clinical documents including clinical study reports according to applicable GCP requirements, regulatory requirements, and guidance documents (including but not limited to ICH E3 guidelines and company SOPs).
- Prepares, independently, other medical writing deliverables including study protocols and investigator brochures (IBs) according to applicable GCP requirements, regulatory requirements and guidance documents (including, but not limited to 21 CFR Part2 312 and 314, EMA Clinical Trials Directives, ICH guidelines and company SOPs and internal style guides).
- Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables
- Assist junior medical writing staff on assigned studies for SOPs and procedures.
- Perform quality checks of all assigned projects
- Assist with Project Management requests as requested.
- Act as a single point of contact for clients for own and associate writer's projects
- Other medical writing duties and responsibilities as assigned.
- Master’s degree or equivalent, preferably in a scientific discipline, clinical sciences, English/journalism, or equivalent experience.
- Fluent English (oral and written)
- At least 3 years or more experience in medical writing within the pharmaceutical industry or related field.
- Rich experience in drafting and review of different types of medical writing documents
- Proven ability to manage and develop people.
- Significant experience with medical writing activities at the group level.
- At least 5 years’ experience in clinical research industry
- Strong problem solving, management and leadership skills with the ability to contribute creative and practical solutions to problems.
- Good knowledge and understanding of ICH GCP and worldwide applicable regulatory requirements
- Must demonstrate the ability to operate in a fast-paced environment.
- Excellent verbal, written communication, and presentation skills.

We strive to provide our employees and their families with benefits that are thoughtfully designed to enhance your health and well-being. Our employees enjoy summer half-day Fridays, paid time off to include vacation, holidays, and sick days, medical, dental, vision, life insurance, short-term and long-term disability, company matching 401K, employee bonus programs, career growth, training and development.

Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.