Our client, a leader in the fight against chronic kidney disease, is dedicated to advancing the care and treatment of millions affected by this serious condition. They are seeking a skilled Regulatory Medical Writer to join their team, supporting global clinical and regulatory efforts.
In this role, you will be instrumental in preparing and managing clinical and regulatory documents for submission to the FDA and other international health authorities. This includes documents such as IND applications, NDAs, MAAs, briefing materials, amendments, and pediatric plans. You'll work closely with cross-functional teams, playing a key role in shaping the regulatory strategy while adhering to high standards of documentation and compliance.
Location: Cambridge, MA (Remote flexibility, some office presence required)
Key Duties and Responsibilities:
- Develop and write clinical and regulatory documents, including protocols, investigator brochures, and dossier modules, in compliance with industry standards.
- Serve as the primary medical writing representative during cross-functional team meetings, providing expertise in document development and timelines.
- Collaborate with teams to ensure documents reflect data accurately and align with regulatory guidance.
- Establish timelines and oversee document development processes to meet submission deadlines.
- Manage and maintain standardized templates to improve document creation and consistency.
- Participate in continuous process improvements within the medical writing and regulatory teams.
Minimum Qualifications:
- Bachelor’s degree in life sciences or related field (PhD preferred).
- At least 5 years of experience in medical or regulatory writing, with a demonstrated understanding of clinical trial and regulatory requirements.
- Proven ability to manage complex projects, including working with external partners and consultants.
- Excellent communication and collaboration skills, enabling effective interaction with cross-functional teams.
- Strong knowledge of document management systems, including Microsoft Office, Adobe Acrobat, and SharePoint. Familiarity with Veeva RIM is a must.
- Experience in managing timelines, formatting documents, and developing templates for regulatory submissions.
- Attention to detail with the ability to adapt to evolving priorities and deadlines.