Senior Clinical Writer Job at Hecta Data (DBA) Vilwaa in Clifton

Job Responsibilities

• Develop and support clinical study/submission strategy for lifesaving therapeutic products in development and through life cycle management considering all relevant guidance, commercial needs, and company objectives.
• Develop strategic direction and provide leadership for all interactions related to clinical/medical studies with FDA/EMA/global regulatory authorities.
• Lead new dossier submissions to global and/or FDA (IND, BLA, NDA, and supplements) utilizing internal and external resources.
• Maintain an up-to-date knowledge of medical terminologies and complex scientific concepts (like cell gene therapy).
• Able to author Module 4 & 5 components for FDA – BLA & EMA new submissions for biologics, preferably in cell gene therapy.
• Conduct literature reviews to support clinical development activities and regulatory submissions, independently producing clinical and regulatory documents in collaboration with cross-functional teams. These documents may include clinical study level documents such as Clinical Study Protocols or Clinical Study Reports, including Phase 1 in patients to Phase 3 across multiple therapeutic areas, preferably in cell gene therapy.
• Thoroughly analyze and critically interpret data to determine the best approach to composing each document, applying lean writing strategies.
• Experience in authoring clinical trial reports for FDA and EMA.
• Writing clinical documents (e.g., new INDs, briefing book content, BT Designation request, Priority Review Requests, ODD); reviewing core documents to support IND/BLA/NDA, in conjunction with EUL or GRL as needed.
• Foster positive relationships with FDA.
• Build and maintain a strong, collaborative relationship with all key stakeholders including Commercial, Medical Affairs, Promotion & Compliance, Global Development, and other functions key to the success of product development.
• Interact routinely and develop a strong team environment with colleagues throughout GRS.
• Ability to lead client meetings and manage project governance.
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.

Job Type: Contract

Work Location: In person