Grant/Medical Writer 03142026

About the Company

Exquisite Biomedical Consulting (EBC) is a boutique life sciences consultancy firm specializing in Medical Affairs, Clinical and Regulatory Strategy, and Evidence Generation for medical device, regenerative medicine, diagnostics, and digital health companies.

We partner with life sciences manufacturers from concept through commercialization of novel medical products and offer services such as fractional Chief Medical Officer support, medical, clinical and regulatory strategy, literature and evidence development, medical writing, and business development.

Role Overview

The Grant / Medical Writer supports EBC and its clients through high-quality scientific, clinical, regulatory, and grant-related writing. This role is central to the development of clear, accurate, and submission-ready documents that support research funding, regulatory compliance, scientific communication, and product development activities.

This role requires a highly organized, analytical, and self-motivated professional who can research, write, edit, and finalize a range of complex documents, including grant proposals, research proposals, EU MDR clinical evaluation documents, manuscripts, posters, presentations, and other scientific and clinical materials. The Grant / Medical Writer will help ensure that all deliverables meet applicable regulatory, scientific, sponsor, journal, and internal company requirements.

Key Responsibilities

1. Grant and Proposal Development

• Design, develop, write, edit, and finalize grant proposals for Canadian and US life sciences funding opportunities, including NIH, MITACS, IRAP, and similar funding programs.
• Support the preparation of research proposals, technical proposals, and other funding-related submissions.
• Organize and synthesize scientific, clinical, and technical information into clear, compelling, and compliant grant applications.
• Coordinate input from internal team members and client subject matter experts to prepare complete and submission-ready grant packages.
• Help ensure that all grant submissions align with sponsor requirements, timelines, and strategic objectives.

1. Regulatory and Clinical Medical Writing

• Prepare, write, and update clinical and regulatory documents for medical devices and related life sciences products.
• Author and support the development of EU MDR clinical evaluation documentation and related regulatory deliverables.
• Draft and revise documents such as Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), Summaries of Safety and Clinical Performance (SSCP), Post-Market Surveillance Plans and Reports, Post-Market Clinical Follow-Up Plans and Reports, and other related documentation, as appropriate.
• Draft and revise sections addressing device description, state of the art, literature review, safety and performance, benefit-risk considerations, post-market data, discussion, conclusions, and summaries.
• Support review cycles, revisions, and responses to internal, client, or regulatory feedback, as needed.

1. Scientific and Medical Writing

• Execute research, write, edit, finalize, and present a range of scientific and medical documents, including manuscripts, posters, abstracts, white papers, slide decks, research summaries, and clinical or scientific reports.
• Support preparation of publication-related and scientific communication materials for internal and client-facing purposes.
• Ensure that all documents are written clearly, accurately, and professionally for the intended audience and purpose.
• Contribute to client projects in alignment with job responsibilities and skill set.

1. Literature Search, Review, and Analysis

• Conduct literature searches using databases and sources such as PubMed, Embase, Google Scholar, Cochrane, and other relevant platforms.
• Screen, review, and critically appraise scientific literature and extract relevant data to support scientific, clinical, regulatory, and grant-related deliverables.
• Summarize findings and document the search and review process in a clear and traceable manner.
• Develop a strong understanding of the relevant technology, disease area, current evidence base, comparator products, and applicable regulatory or scientific context.

1. Editing, Formatting, and Compliance

• Edit, proofread, format, and finalize documents to ensure consistency, accuracy, grammar, syntax, and professional presentation.
• Ensure compliance with applicable regulatory, scientific, sponsor, journal, and internal company requirements.
• Follow EBC SOPs, client procedures, templates, and writing guidelines in preparing all deliverables.
• Help ensure documents are complete, well-organized, and aligned with submission or publication expectations.

1. Project Coordination and Communication

• Manage workload effectively and adhere to timelines across multiple simultaneous projects and deliverables.
• Communicate regularly with the CEO and relevant team members regarding progress, project challenges, and accomplishments.
• Collaborate with internal colleagues and client teams to support timely, high-quality project execution.
• Undertake ad hoc tasks and writing-related projects as assigned, demonstrating flexibility and willingness to contribute to various aspects of the organization’s work.

1. Confidentiality, Professionalism, and Business Conduct

• Maintain strict confidentiality in relation to company, client, and project information.
• Demonstrate professionalism, sound judgment, integrity, and discretion in all interactions.
• Follow EBC internal policies, procedures, and expectations for ethical business conduct.
• Handle sensitive scientific, clinical, regulatory, and business information with care and maturity

Qualifications

• Graduate degree in a scientific discipline required.
• At least 1 year of experience writing grants for Canadian or US life sciences grant providers.
• At least 3 years of experience writing manuscripts, complex clinical or scientific documents, and EU MDR-related documentation.
• Experience following SOPs, templates, and guidelines in a regulated or quality-conscious environment.
• Familiarity with medical device and/or pharmaceutical regulations and related scientific documentation requirements.
• Proven ability to conduct literature searches, critically review evidence, and extract relevant data to support decision-making and document development.
• Strong writing, editing, formatting, and document development skills.
• Self-starter with the ability to thrive in an entrepreneurial environment.

• Permanent authorization to work in Canada.

Nice to Have Qualifications

• Experience writing Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER), SSCPs, PMS, PMCF, PSUR, or related regulatory documentation.
• Familiarity with EU MDR, MEDDEV guidance, ISO standards, and other applicable medical device or pharmaceutical frameworks.
• Experience in medical devices, pharmaceuticals, diagnostics, biotech, or consulting environments.
• Experience preparing manuscripts, posters, presentations, and scientific communications for publication or external presentation.
• Strong proficiency with Microsoft Word, PowerPoint, Excel, and literature/reference management tools.

Skills and Competencies

Technical / Hard Skills

• Strong grant-writing, scientific writing, and regulatory writing capabilities.
• Strong literature search, evidence appraisal, and data extraction skills.
• Ability to prepare clear, structured, and submission-ready documents across multiple formats.
• Strong editing, proofreading, formatting, and document quality control skills.
• Familiarity with regulatory, scientific, sponsor, and journal submission requirements.
• Ability to manage multiple writing projects while maintaining quality and timelines.

Soft Skills

• Highly organized, detail-oriented, and dependable.
• Strong analytical thinking and problem-solving abilities.
• Professional, discreet, and trustworthy with confidential information.
• Self-motivated, resourceful, and comfortable working independently.
• Able to prioritize effectively and work in a fast-moving entrepreneurial environment.
• Strong written and verbal communication skills.

What We Offer

• Opportunity to work on meaningful scientific, clinical, regulatory, and funding-related projects within a growing boutique life sciences consultancy.
• Exposure to a range of innovative medical device, biotech, diagnostics, and healthcare projects.
• Flexible and entrepreneurial work environment.
• Opportunity to collaborate with experienced professionals across multiple disciplines.
• Opportunity to contribute meaningfully to the growth and effectiveness of a high-impact consulting firm
• Flexible and entrepreneurial work environment.

How to Apply:

Please send an e mail with your resume and a cover letter, if desired, to admin@exquisitebiomedical.com.

Include in the subject line: Grant/Medical Writer 03142026