What are the responsibilities and job description for the Senior Clinical Writer Job at Hecta Data (DBA) Vilwaa in Clifton position at Hecta Data (DBA) Vilwaa?
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
J-18808-Ljbffr
