Description
Position Summary: The Principal Medical Writer, Clinical Affairs will lead the development and execution of clinical and performance study documentation to support in vitro diagnostic (IVD) products, including companion diagnostics (CDx). This role is responsible for authoring Clinical Performance Study Plans (CPSPs), Investigator’s Brochures (IBs), Performance Study Reports (PSRs), and other regulatory documents in alignment with global requirements, particularly under the In Vitro Diagnostic Regulation (IVDR).
The Principal Medical Writer will collaborate closely with cross-functional teams and external partners—including pharmaceutical sponsors, consortia groups, and CROs—to ensure high-quality and strategically aligned documentation in support of regulatory submissions and clinical objectives. This individual will also provide subject matter expertise on clinical study design and clinical evidence generation, playing a critical role in advancing diagnostic innovation and ensuring compliance across global clinical development programs.
Key Responsibilities
- Lead the creation and review of Clinical Performance Study Plans (CPSPs), Investigator’s Brochures (IBs), and Performance Study Reports (PSRs) in accordance with global regulatory requirements (e.g., IVDR, FDA, ISO 20916). This includes studies conducted in partnership with pharmaceutical collaborators, consortia groups, and where applicable, company-sponsored studies.
- Support clinical strategy and study design, providing clinical input on study plan/protocol development, and planning for performance studies involving in vitro diagnostics (IVDs), including companion diagnostics (CDx).
- Act as the Clinical Affairs representative on cross-functional teams, including Medical Affairs, Regulatory Affairs, Scientific Communications, Product Development, and Business Development—offering subject matter expertise on clinical evidence generation and regulatory compliance across global geographies.
- Coordinate or contribute to the development of submission-ready documentation, including clinical study summaries, and clinical-based responses to regulatory authorities for CE marking or other global approvals.
- Collaborate with external partners including contractors, vendors, pharmaceutical sponsors, academic and consortia groups to ensure alignment on study-related deliverables.
- Contribute to continuous improvement of clinical affairs processes, including SOP development, templates, and workflows to support documentation quality, operational efficiency, and regulatory readiness.
- Serve as the clinical affairs representative in cross-functional teams, including Medical Affairs, Regulatory Affairs, Scientific Communications, Product Development, and Business Development, providing expertise on clinical study design and regulatory compliance under the IVDR.
- Oversee the preparation and submission of clinical study documentation for regulatory purposes.
- Stay informed of evolving regulations and standards, ensuring clinical processes remain compliant and efficient.
Qualifications
- Bachelor’s degree in a scientific or medical discipline is required; an advanced degree (e.g., Master’s, Ph.D., PharmD) is strongly preferred.
- 8–12+ years of experience in medical writing or a closely related field within the diagnostics, pharmaceutical, or medical device industry, with a demonstrated track record of producing high-quality clinical and regulatory documentation.
- Hands-on experience developing Clinical Performance Study Plans (CPSPs), Investigator’s Brochures (IBs), Performance Study Reports (PSRs), and other documentation in support of regulatory submissions under IVDR or similar frameworks.
- Proven ability to manage multiple priorities and complex projects in a fast-paced, cross-functional environment, while maintaining attention to detail and regulatory compliance.
- Strong communication and collaboration skills, with the ability to interface with cross-functional teams, including Regulatory Affairs, Clinical Affairs, Medical Affairs, and Scientific Communications.
Nice to Have
- Professional certifications (e.g., RAC, ACRP, CCRP, or equivalent)
- In-depth knowledge of IVDR and performance study documentation requirements, particularly for companion diagnostics (CDx).
- Background in oncology, molecular diagnostics, or related clinical fields is strongly preferred.
- Experience in medical writing for medical devices and/or in vitro diagnostics is highly valued, especially in the context of European and global regulatory pathways.
Knowledge, Skills, and Abilities
- Drive for learning and problem-solving
- Demonstrated teamwork skills
- Excellent communication and organizational skills