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Senior Medical Writer

Canada - Any Region - Home Based Date posted 09/11/2019 Job ID 55048BR

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.

  • Full Time
  • Level: Mid
  • Travel: No
  • Glassdoor Rating 3.5

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
  • "I am part of a great team! My colleagues at Parexel are a pleasure to work with, are
    knowledgeable, experienced, caring and always ready to help!"

    Anne-Christin Friedrich - Senior Medical Writer
  • "I really enjoy learning about the vast areas of clinical writing. Everyone is very professional,
    knowledgeable, and it is easy to communicate with other staff."

    Christine Simmons, Medical Writer II
  • "Parexel makes it easy to communicate and interact with each other, which allows
    me access to expertise and knowledge beyond my own."

    Kristy Haslerud, Associate Manager
  • "Since the day I started, I have learnt something new from people on my team: it can be something associated with medical writing, the latest technology, or a tool that enhances/ aides writing."

    Erangi Tennakoon, Medical Writer II

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.

Responsibilities

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.

Qualifications

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
  • Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.
  • Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned
  • Understands and satisfies 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.
  • Provides departmental expertise and perspectives to promote prospective business opportunities; provides Parexel colleagues with pertinent information to formalize a sound business strategy.
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 documents: study reports, study protocols, or CTD documents or similar.
  • Advanced word processing skills, including MS Office (expertise in Word); software and systems
  • knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).
  • Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation.
  • If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.
Education:
  • Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.

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