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Medical Wrtiter Ii

2 weeks ago

Remote, Canada Parexel Full time

Parexel's Regulatory Medical Writing Services works closely with our clients around the world to develop and launch new medicines and treatments that improve healthcare for millions of patients. We’re one of the largest providers of medical writing services worldwide, and have managed thousands of writing projects in more than 29 countries across North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction and business growth, this global team is expanding and offers many opportunities for career development.

In this role, you’ll prepare clinical documents for comprehensive clinical trials and programs. Using compliant Parexel and sponsor formats, styles and management systems, you’ll manage clinical document deliverables such as model informed consent forms, clinical study reports, pharmacovigilance documents and more. Our Medical Writers also participate in ongoing professional development programs to maintain current knowledge in the various areas. Explore opportunities within our core Clinical Development, Biotech, or Functional Service Provider (FSP) teams below.
- Full Time
- Travel: No
- Glassdoor Reviews and Company Rating

**Success Profile**:
Check out the top traits we’re looking for and see if you have the right mix.
- Detail-Oriented
- Deadline-Oriented
- Communicator
- Organized
- Versatile
- Tech-Savvy

**Rewards**:

- **Global Impact**: We are one truly global team working together to propel each client´s journey ahead faster.
- **Work-life Balance**: We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.
- **Career Development**: Opportunity to learn and grow through a performance and development goal-setting program.
- **Home based**: Love where you work, and work where you love.
- **Variety**: Opportunity to work on a wide range of therapeutic areas, document types and clinical projects.

**Home Based US or Canada (Full Time 100% remote)**

Parexel is one of the largest providers of medical writing services worldwide and has managed thousands of writing projects in more than 29 countries in North and South America, Europe, Asia, and Africa. As a result of continued customer satisfaction, the Team is growing. We are currently looking for:
As a Parexel Medical Writer II you will be exposed to different project teams, therapies and devices, as well as a diverse portfolio of clients. The ability to understand our clients’ needs and achieve quality results is critical for us to continue to be one of the best clinical research organizations (CROs) in the world. To accomplish this, we believe that you must have the ability to work independently as well as collaboratively every day.
Our writers are an integral part of clinical teams that support our clients worldwide and they assist those teams in writing and coordinating successful documentation across a wide range of therapeutic areas. Under departmental supervision, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with submissions to regulatory authorities, including but not limited to: study protocols, model informed consents, interim and final clinical study reports, and safety update reports. The Medical Writer II will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission. The Medical Writer II may serve as the primary client contact.

**Skills**
- Excellent interpersonal, verbal, and written communication skills.
- Ability to consistently produce documents of high quality.
- Demonstrates attention to details and proactivity.
- Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
- A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
- Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.
- Willingness to work in a matrix environment, values the importance of teamwork, and understands roles of other project team members. Possesses team leadership skills and cross-cultural sensitivity.
- Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
- Strives to understand and satisfy client needs.
- Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services.

**Knowledge and Experience**:

- Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP.
- Extensive clinical/scientific writing skills.
- Scientific background essential; writing experience includes multiple clinical study reports.
- Advanced word processing skills, includi