Regulatory Compliance, Open to flexibility
Regulatory Compliance, Open to flexibility
Responsible for the production (authoring), in terms of quality and regulatory acceptability, of nonclinical material (sections) produced for clinical trial or marketing applications or associated written regulatory materials.
- Identifies the critical elements of nonclinical submission components required in order to achieve a successful outcome to the communication.
- Seeks to resolve problems in a proactive manner. Identifies problems to supervisor suggests or describes solution to obtain endorsement to approach executes solution.
- Ensures all regulatory reporting requirements associated with assigned project are met by analyzing situations to clearly establish both problem and the root causes, seeks to resolve in a proactive manner.
- Is able to effectively manage own time across multiple tasks and projects working on projects in parallel.
- Works flexibly but within the limitations of internal and external requirements with Safety Assessment, DMPK, Clinical R & D and Regulatory Affairs to agree strategy for resolution of specific issues for Format and Content relating to individual development programmes.
Ensures the adoption and compliance with defined writing standards by self and within own Team.
- Authors nonclinical contribution to regulatory submissions (drawing support from scientists)
- Can assist with training and development for members of the team and provision of training and guidance to members of the GRA organization outside of NCR.
- Anticipates regulators questions regarding data results or format or content
- Builds a scientifically persuasive case for the validity of the results and clearly communicates to internal stakeholders and regulators
- Applies regulatory insight to data interpretation and makes recommendations for future studies
Ensures regulatory governance and regulatory reporting at the nonclinical level to assure company standards for disclosure to the regulatory authorities, scientific integrity and overall safety for patients or study subjects.
- Ensures quality responses by self and own Team in compliance with company standards for disclosure, in all external communications etc.
The major output of this position are:
- Provision of Regulatory Advice and expertise to a range of development projects and more broadly across the Global Regulatory Affairs and Preclinical Development Organizations.
- Authoring nonclinical components of regulatory submissions and communications.
- This role does not generally require the management of staff. Some staff supervision, on training or mentoring basis, may be required from time to time.
- Bachelor of Science Degree in a relevant Subject (Life Science) required; prefer higher degree or relevant professional qualification, or equivalent practical experience
- 5+ years of post graduate scientific and regulatory experience
- Thorough understanding of pharmacology, toxicology and pharmacokinetics related to drug development
- Thorough understanding of regulatory processes and issues
- Thorough understanding of the regulations relevant to nonclinical development
- Knowledge of GSK Regulatory Function and processes
- Excellent verbal, written, presentation and organization skills
- Competent and experienced in interacting with staff outside direct reporting line.
- "Hands on" experience in the production of nonclinical components of regulatory submissions are a plus
- Drug Development Expertise - Demonstrates an understanding of the process of taking a new chemical lead through all the stages (early development to life cycle management) necessary to allow it to be tested in human clinical trials and marketed worldwide (i.e. the entire process of drug discovery, clinical testing and product maintenance)
- Submission Production Experience - Has demonstrated experience in the development of regulatory strategy as well as the, planning, design, execution, and delivery of a wide range of high quality clinical trials and marketing applications.
Competencies and Capabilities
- This person will manage, under supervision, (either alone or as a part of a team of writers lead by a Team Manager) the nonclinical regulatory support for a portfolio of global R&D (i.e. multiple n=>3) projects (across all research and therapy areas) to be worked on by self and a team of nonclinical writers. The complexity of the project(s) assigned and the degree of supervision required will depend directly on the position in the grade and experience of the individual with lesser experience requiring a higher degree of supervision. The projects will be at all stages of development, thus, support will be from pre-first time in human, throughout clinical trials and marketing applications to post-licensing life cycle support.
- Projects are assigned on the basis of relative priority, available of resource and complexity i.e. in terms of size, nonclinical issues and variety of outputs required.
- Demonstrates a high level of understanding of regulatory requirements in general and a detailed understanding of those requirements of relevance to nonclinical development as well as internal policies, procedures, and guidelines. Uses this knowledge to prepare or provide input into the preparation of nonclinical submission documentation.
- Works flexibly but within the limitations of internal and external requirements with Project representative from Safety Assessment, DMPK, Clinical R & D and Regulatory Affairs to prepare nonclinical components of submission documentation.
- Production of submission materials and documentation is an essential component of the GSKs ability to communicate with Government Regulatory Agencies. Obtaining the best possible license approval in the fastest possible time is fundamental to the company's business success. This role is as a Team Member tasked with doing this under supervision by a Nonclinical Submissions Team manager.
- Nonclinical Judgment Experience - Has demonstrated a proven track record of effectively applying expertise to make good strategic regulatory decisions.
- Scientific Excellence (Regulatory and Scientific knowledge) Regulatory Expertise -Demonstrates a high level of understanding of regulatory requirements of relevance to nonclinical development as well as internal policies, procedures, and guidelines.
- Uses this knowledge to prepare a range of clinical trials and marketing application components appropriate to requirements.
- Scientific Regulatory Writing - Ability to produce written regulatory scientific communications with clarity, accuracy and rigor.
- Commercial business Expertise - Demonstrates an understanding of company development priorities and responds appropriately and flexibly to ensure deadlines are met successfully.
In this role the individual is responsible to their line for the timely production of approved documentation for clinical trials and marketing applications for use world-wide. The role requires direct responsibility for the quantity and quality of the job holders own work. The production of submission documentation involves leadership of mixed function teams and collaboration with scientific functions at all levels to ensure that the scientific content reflects both the totality of the company's (GSK) knowledge and the company's position in a suitable and compelling manner.
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