Job Description: We are inviting applications for the role of Sr. Clinical writers.
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, 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 produces 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. This includes 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.
Exp in authoring clinical trial reports for FDA and EMA mainly
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 will develop a strong team environment with colleagues throughout GRS.
Ability to lead client meetings and managing 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.
Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
Demonstrated understanding of related fields
Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
Demonstrated effective leadership, communication, and interpersonal skills.
Strong ability to work successfully in a matrix environment and to lead teams successfully toward drug approvals.
Significant experience in clinical writing
Expert understanding of policy, laws, regulations, and guidelines as they apply to U.S. FDA & EMA for drug development and approval.
Expert understanding of drug development process and understanding of scientific content and complexities related to a project in life-saving therapeutic drugs.
Direct experience in developing strategy and leading teams through interactions with FDA/EMA.
Extensive experience in initiating and conducting successful interactions within FDA/EMA.
Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
Demonstrates ownership of results within (and beyond) area of responsibility.
Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
Looks for opportunities for continuous improvement.
Qualifications we seek in you!
Ph.D., M.D., PharmD., MS or commensurate experience
Experience level : 12 18 years
Additional Sills:

Skills:	Category Name Required Importance Experience No items to display.