SENIOR BIOSTATISTICIAN: Job Code C-08
MISSION STATEMENT: The Senior Biostatistician will support clinical trial activities in accordance with industry standards for research, and relevant regulations and guidance documents. It is expected that the Senior Biostatistician will be able to work independently.
RESPONSIBILITIES: A large portion of effort will be directed to oversight of biostatistical services provided by clinical CROs. An understanding of industry standards for data management procedures used to collect, compile, and present clinical data is required. Responsibilities will include activities that support the planning, analysis, review, and interpretation of clinical data sets from research projects and protocols conducted by the clinical research group. Activities will include, but are not limited to, working with study team members on pre-study planning, protocol development (in particular, the statistical section of the protocol including sample size/power calculations), Statistical Analysis Plan preparation/review, oversight of the biostatistical activities of contractors and contract research organizations (CRO), data quality reviews, and review of tables / listings / figures and clinical study reports. Some SAS programming is required in response to requests from Clinical and other departments, and could include preparation of data distributions and data sets, and ad hoc listings and data analysis.
REQUIREMENTS: Education: MS/PhD
Experience: A minimum of 6 years industry and/or CRO experience with the design and analysis of clinical trials is required; 3 years of experience in a pharmaceutical or biotech sponsor organization is preferred. Demonstrated knowledge of applied clinical research statistics in support of pharmaceutical and/or biologics product development is required. The work history should demonstrate evidence of the ability to effectively manage numerous projects simultaneously and in an efficient manner. Experience with verbal and written communications with the FDA (CDER and/or CBER preferred) is required; experience with European regulatory filings and/or European clinical studies is preferred. Some experience with management of outside contractors/CROs is preferred. Excellent verbal and written communication skills and attention to detail are required as this position must function as an integral part of the study team.
REGULATORY AFFAIRS MANAGER: Job Code C-09
DESCRIPTION:
The Manager, Regulatory Labeling and Promotion, is responsible for the management of regulatory activities in the support of external commercial communications, labeling development, and labeling maintenance. This person represents regulatory in cross-functional teams that review and/or approve promotional materials, sales training materials, press materials, and other external communications. This person represents regulatory in cross-functional teams that develop draft labeling for regulatory authority review and approval and maintains labeling after approval. and will be a liaison with regulatory authorities and other functional teams in matters relating to labeling and promotions.
EXPERIENCE/EDUCATION:
MS/PharmD preferred. Good knowledge of labeling and advertising regulations, guidance, and agency regulatory action history is required. Minimum experience 2 years in regulatory promotional review or labeling required. Demonstrated good oral (speaking and listening) and written communication skills, including effective presentation to audiences at all levels; demonstrated ability to influence decisions of a team; can act as a liaison.
REGULATORY AFFAIRS CMC Associate, Manager and /or Assoc Director: Job Code C-10
MISSION STATEMENT: Provide Regulatory guidance, strategic advice and contribute to a Regulatory project team planning on CMC issues. Handles all aspects of CMC-related activities for assigned biological development project.
RESPONSIBILITIES: • Review and assessment of all CMC documents for consistency; • Accuracy and conformance with all regulatory requirements; • Identification of content, responsibility and timing of CMC documents for regulatory submissions; • Coordinating and monitoring the progress of all CMC regulatory submissions; • Providing regulatory guidance for CMC issues, processes and templates by working closely with Manufacturing and Quality through all phases of drug development; defining current regulatory requirements for technical submission (INDs, CTXs, BLAs, and DMFs); • Directly interacting with regulatory authorities(internal) and Manufacturing and Quality (external) on CMC issues requiring agency feedback; and participating in pre-approval inspection activities.
EXPERIENCE: • A minimum of a BA or BS in chemistry (although other physical or biological sciences will be considered) with 2-5 year’s prior experience. • Must be detailed oriented individuals capable of performing tactical CMC Regulatory Affairs Duties.
REGULATORY AFFAIRS MANAGER: Job Code C-11
DESCRIPTION:
Reporting to the Associate Director of Regulatory Affairs, the Manager will be responsible for determining Regulatory strategy for specific projects relating to the development of new formulations, new delivery systems and new indications for commercial products as well as post-marketing commitments and Phase 4 studies. The Manager will also serve as the RA representative on relevant project teams and as the primary regulatory contact with regulatory authorities in the US and Canada. Specific duties include but are not limited to:
-Represent RA on all relevant project teams
-Responsible for the development and implementation of RA strategy for assigned projects and programs
-Responsible as the primary contact for all communications with the regulatory agencies relevant to assigned projects or programs.
-Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
-Prepares written and oral presentations of Regulatory plans to project teams and Senior Management.
EDUCATION/EXPERIENCE:
The position requires a BS/MS with at least 4 years of prior regulatory experience. Extensive knowledge of US regulations required, some international regulatory experience preferred. Excellent verbal and written communication skills are essential as are organizational and planning skills.
V.P. REGULATORY AFFAIRS: Job Code C-12
MISSION STATEMENT: To develop, support and manage regulatory strategies. To review and approve data packages for product candidates to ensure completeness, accuracy and validity of data in support of regulatory applications.
RESPONSIBILITIES:
• Anticipate consequences and assess impact of new or revised worldwide regulations and guidelines on the company’s strategies. • Review and approve key segments of regulatory submissions. • Represent the company and effectively participate with senior level representatives of regulatory agencies worldwide. • Effectively interact with senior company management to influence direction of the Regulatory Affairs group and associated company efforts. • Communicate to senior management regulatory strategic & tactical plans to achieve company goals. • Act as recognized leader in the drug development process with comprehensive and business knowledge in a variety of product areas. • Work closely with R&D to develop an overall drug development strategy for all of the company’s products. • Allocate resources and coordinate the activities of personnel to achieve the company’s objectives. • Maintain an organization with high-level competencies and develop a succession plan for the group, to achieve the company’s objectives. • Act as a recognized expert to work teams and other functional organizations on complex problem resolution.
EXPERIENCE:
• An advanced degree • 10-15 years of industry experience • Attention to detail and follow through • Medical / Pharmaceutical specified education • 5-10 years of experience in dealing with the FDA • Extensive communication skills
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