Medical Writer I

2 days ago

Guelph, Canada Nutrasource Full time

**Position Overview**:
Our rapidly expanding team is seeking a **Medical Writer** **I **who can work for us on a full-time basis. The **Medical Writer I **is responsible for developing high-quality, scientifically valid clinical and regulatory documents for development of health products (dietary supplements, natural health products, pharmaceutical drugs and biologics) according to internal document standards and within project timelines.

**Primary Responsibilities**:

- Writes and integrates appropriate statistical and clinical data into protocols, investigator brochures, informed consent forms, clinical study reports, responses to regulatory questions and other clinical and regulatory documents
- Helps Medical Writer IIs manage the overall development and approval process for assigned documents within timelines, including document generation, initiation of review process, discussions on proposed revisions, and document completion in collaboration with other study team members
- Critically analyzes complex information and collaborates with clinical and statistical teams on data description, presentation and analysis
- Represents medical writing on project teams and actively participates in interactions including provision of scientific background information as needed
- Develops and maintains in-depth therapeutic and product area knowledge
- Provides quality control review of various regulatory and medical communications documents
- Promotes GXP compliance across the organization
- Other duties as required and as training and experience allow
- Maintains an attitude and philosophy consistent with the Company’s standards

**Core Competencies**:

- Demonstrated ability to produce clear, concise, and effective written and verbal communications describing scientific and clinical data in English
- Some experience in writing, editing, reviewing, and formatting clinical regulatory documents, or similar scientific documents (e.g., grants, manuscripts)
- Some understanding of clinical product development, clinical research, clinical study design, biostatistics, medical terminology, the regulatory environment including Health Canada/FDA/ ICH guidelines, and principles of GXP/ICH/CTD and other global standards
- Ability to work collaboratively and coordinate the efforts of team members to resolve comments and produce a final high-quality document
- Independently motivated with good problem-solving skills allowing analysis, synthesis and compilation of data from a broad range of disciplines
- Well-organized with demonstrated ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to timelines
- Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy
- Fluent in word processing, flow diagrams and spreadsheets
- Ability to critically review own work before sending out for internal/external review by team
- Ability to work in a fast-paced, cohesive, collaborative team-oriented work environment

**Qualifications**:

- BS/BA degree or equivalent experience in a scientific or health related field
- 1-2 years writing experience as a Medical Writer in the health care industry (e.g. medical/ regulatory/publication writing in the pharmaceutical/nutraceutical/biotech/device, medical communications, CRO or similar industries)

**Job Types**: Full-time, Permanent

Additional pay:

- Bonus pay

**Benefits**:

- Dental care
- Extended health care
- Vision care

Schedule:

- 8 hour shift

Work Location: In person

  • Medical Writer I

    5 days ago

    Guelph, Canada Nutrasource Full time

    **Position Overview**: Our rapidly expanding team is seeking a **Medical Writer** **I **who can work for us on a full-time basis. The **Medical Writer I **is responsible for developing high-quality, scientifically valid clinical and regulatory documents for development of health products (dietary supplements, natural health products, pharmaceutical drugs and...

  • Scientific Writer

    1 week ago

    Guelph, Canada LifeLearn Inc Full time

    **Job Summary** LifeLearn is actively seeking a full-time Scientific Writer to join our dynamic team of creators. The Scientific Writers are a part of the award-winning Industry Solutions Team at LifeLearn. The Industry Solution team has a broad range of skills in design, medical illustration, science writing, video creation, web design, campaign branding...

  • Science Writer

    1 week ago

    Guelph, Canada LifeLearn Inc Full time

    At LifeLearn we have a passion for creating innovative, data driven solutions in the animal health industry. Our team based, collaborative culture is the foundation for building educational and efficient products that make a difference in the animal health community. LifeLearn is also a company that empowers our diverse team, provides a flexible work...

  • Scientific Writer, Industry Solutions

    1 week ago

    Guelph, Canada LifeLearn Full time

    LifeLearn is actively seeking a full-time Scientific Writer to join our dynamic team of creators. The Scientific Writers are a part of the award-winning Industry Solutions Team at LifeLearn. The Industry Solution team has a broad range of skills in design, medical illustration, science writing, video creation, web design, campaign branding and much more. We...

  • Medical Writer

    5 days ago

    Guelph, Canada MEDUCOM Health Inc. Full time

    **Position Description: Medical Lead** **Are you proactive, results-oriented, with demonstrated communication skills and a passion for learning?** If so, a position at MEDUCOM is right for you! MEDUCOM is a full-service healthcare communications agency, which conceptualizes and delivers pharmaceutical marketing and medical education services. MEDUCOM has...

  • Content Writer

    2 weeks ago

    Guelph, Canada Prompt Core Full time

    **CONTENT WRITER - LLM** **Wage 60k** **DUTIES** - Develop creative and effective prompts to guide the language model in generating relevant and high-quality output. - Conduct thorough assessments of the model's responses, identifying areas for improvement and refining prompts to enhance accuracy and coherence. - Implement a continuous improvement process...

  • Medical Lead

    5 days ago

    Guelph, Canada MEDUCOM Health Inc. Full time

    **Position Description: Medical Lead** **Are you proactive, results-oriented, with demonstrated communication skills and a passion for learning?** If so, a position at MEDUCOM is right for you! MEDUCOM is a full-service healthcare communications agency, which conceptualizes and delivers pharmaceutical marketing and medical education services. MEDUCOM has...

  • French Language teacher

    15 hours ago

    Guelph, Canada Language Trainers Full time

    Language Trainers is a successful language training company working with freelance teachers of 70 different languages in hundreds of towns and cities across the world. Students are either in-company or self-funded who need to learn a language at their office or their home for work, family or travel reasons. Founded in 2004, the company’s motto is Any...

  • Personal Care Attendant

    2 weeks ago

    Guelph, Canada Maddy Workman Full time

    My name is Maddy Workman I am a 22 year old young woman living with cerebral palsy and I use a power wheelchair to get around. I am very responsible, funny, sarcastic, caring, outgoing and willing to try new things. I have a great sense of humor and I love listening to pop music and singing along. I am looking for female personal care attendant’s to assist...

  • Packaging Operator I

    1 week ago

    Guelph, Canada Johnson & Johnson Full time

    Johnson & Johnson is recruiting for a 12-month contract-to-hire Packaging Operator I position, located in Guelph, Ontario, Canada. The position will seat on the 1st shift Monday - Friday (6:30 am to 2:45 pm). The Johnson & Johnson Guelph site is a member of the Johnson & Johnson Family of Companies, the world's most comprehensive and broadly based...