English Medical Writer Jobs

Experience managing writing activities for a major US or international regulatory submission (project/people management) preferred.

Understand regulatory submissions requirements and clinical study report guidelines in host country.

Exhibit excellent and oral communication and presentation skills.

At least 5 plus years of experience regulatory writing for pharma or biotechnology required.

Experience as lead writer for key documents included in major US and/or international regulatory submissions required.

Ability to understand Sponsor guidelines and requirements related to the preparation and production of regulatory documents and submissions.

Attention to detail and strong time management skills.

Use your editorial skills to vet the analysis and first person stories from within the CBC and from outside contributors.

Demonstrated experience working in a news and breaking news environment.

Strong communication and interpersonal skills; a standout colleague.

University degree in journalism or equivalent with a minimum of three years of recent, related experience.

Respond quickly to breaking news events as they unfold.

Mentors and leads less experienced medical writers on complex projects, as necessary.

Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.

Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.

Acts as lead for assigned writing projects.

The requirements listed below are representative of the experience, education, knowledge, skill and/or abilities required.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

Travel: Some travel may be required for meeting with clients, stakeholders, or off-site personnel/management

Strong written and oral communication skills and interpersonal skills

Strong critical thinking, analytical, problem-solving, and multitasking capabilities

Liaise with project stakeholders as required

Excellent project/time management and organizational skills, and ability to work independently.

Thorough knowledge of applicable regulatory requirements and guidelines (in particular ICH E3, E6, and E9).

Minimum of 3 years of clinical pharmaceutical industry experience including skills and competency in medical writing.

Prepare product documents such as investigator drug brochures, summary documents, and others in accordance with regulatory requirements and WCT SOPs.

Create and manage project-specific timelines, and adaptation of timing and milestones based on client needs/feedback.

Flexibility in meeting challenging deadlines and changing requirements while working on multiple projects.

Mentors and leads less experienced medical writers on complex projects, as necessary.

Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.

Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.

Extensive knowledge of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.

Demonstrated high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills and ensure a team-oriented approach.

Acts as lead for assigned writing projects.

MSc in Life Science and Medical Writing experience, or PhD in Life Science

Works with clients and managers to ensure that all deliverables meet the required standards for content, format, and style

Reviews material created by other writers to ensure it is accurate and meets the client’s requirements

Develops effective assessment and measurement for learning experiences/solutions

Link to our website page: https://www.linkedin.com/company/niitmts/mycompany/

Ability to understand scientific/medical information and data in various biological fields

• Contribute to RMPs/dRMPs, benefit-risk assessment reports, signal detection reports and other safety reports as required;

• 5 Years of relevant PV experience

• Canadian experience in writing aggregate reports is mandatory

• Proficient business communication skills in English

• Ensure compliance in the submission of aggregate reports to regulatory authorities

• Plan and execute literature monitoring (global and local)

Previous experience/knowledge of Gastroenterology is an asset.

Support Manager, Medical Writing or project lead with timeline development and time estimates for writing deliverables.

Minimum of an undergraduate degree (advanced degrees preferred) and 7-9 years of relevant experience in medical writing.

Previous experience with CSRs, IBs, Protocols, and ICFs.

Highly refined written and oral communication skills.

Accommodations for job applicants with disabilities are available

Use your project management skills to lead teams to quality and timely deliverables

Use your clinical knowledge to write and edit clinical study documents

Excellent interpersonal, verbal, and written communication skills.

Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.

Extensive clinical/scientific writing experience is required and consists of multiple clinical documents: study reports, study protocols, CTD documents and/or similar.

Lead Medical Writing experience with late phase documents (protocols, CSRs, CTDs) (Phase III) is required.

Detail-oriented with exceptional organizational and time management skills to prioritize and meet deadlines while maintaining high-quality work.

Proficient in using scientific literature databases, citation management tools, and Microsoft Office suite.

5+ years of relevant experience in the field of medical/scientific writing.

Proven experience working as a Medical Writer, preferably in a pharmaceutical, biotechnology, or contract research organization (CRO) setting.

Excellent written and verbal communication skills, with the ability to effectively communicate complex medical information to diverse audiences.

Strong analytical and critical-thinking skills to interpret and synthesize complex scientific data into meaningful content.

Demonstrated excellent presentation, writing, and project management skills

Interprets data and applies knowledge of regulatory/compliance/scientific requirements to document preparation

Applies knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects

Is recognized as a scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation

Represents medical writing in cross-functional teams

May participate in orientation and coaching of junior team members or contractor writers

Participation in the Strangers on a Train reading series

Social engagement(s) with College faculty/administration

Office hours two days a week for manuscript consultations with students

Classroom visits for creative writing and literature

5 pm PST on Wednesday, July 12 2024

Hours may vary according to the needs of the department.

Organizational and communication skills are important to the role. This includes strong project management skills.

Education level should be at the bachelor's level.

This role is suitable for someone with the following qualifications:

Renumeration will be paid on an hourly basis, at a rate negotiable based on experience.

You are passionate about evidence-based research, including presenting contradictory findings in an unbiased and balanced format.

You are able to work independently as well as with a wider team.

MINIMUM KNOWLEDGE, SKILLS AND ABILITIES:

Travel: Some travel may be required for meeting with clients, stakeholders, or off-site personnel/management

Strong written and oral communication skills and interpersonal skills

Strong critical thinking, analytical, problem-solving, and multitasking capabilities

Liaise with project stakeholders as required

Conduct structured or systematic searches of medical literature

Proven project leadership and/or project coordination or project management experience; experience with digital projects an asset

Develop and assist in the writing and management of medical content

Contribute to the development and ongoing management of timelines

Develop and manage compliance reviews using client software

Prepare and manage submissions to regulatory (e.g., PAAB), ethics (e.g., IRB) and accrediting (e.g., CFPC) bodies

Excellent communication skills, both verbal and written

Ideally, 2+ years experience with a background in life sciences and current writing experience in Healthcare/ Medical Communications and Medical Education

Draft high-quality clinical, medical and educational documents

Able to understand scientific and clinical information and then use that knowledge to create strategic and captivating content for various audiences

Understanding of the key requirements for regulatory submissions

Medical Writer – Medical Education

Toronto, ON – Canada (REMOTE)

•Demonstrated ability to manage multiple tasks utilizing excellent organizational and time-management skills.

A combination of education and experience may be considered

•Travel, as needed, to Calgary Zone communities to attend meetings, gather information and provide project management leadership.

Minimum of 5 years clinical experience, or Master’s degree in a scientific discipline plus a minimum of 2 years experience

•Strong oral and written communication skills with the ability to adapt to the audience and desired results.

Master’s degree in a health science preferred

Relevant education (M.Sc. or higher, as well as 2+ years’ writing experience)

Experience with medical education or communications is preferred

Working knowledge of pharmaceutical process/requirements

Draft high-quality clinical, medical and educational documents

Maintain document history and manage version control by following the OH process

Advanced oral and written communication skills (bilingualism an asset)