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.
NOTE: An opportunity also exists for a DIRECTOR OF BIOSTATISTICS.
SAS DEVELOPER / PROGRAMMER: Job Code C-09
RESPONSIBILITIES: * Design and conduct outcomes studies * Prepare research plans and protocols * Design data collection forms * Conduct analyses of data * Prepare reports and manuscripts for publication
QUALIFICATIONS: * Masters with 3-5 years (or Bachelors with 6+ years) of advanced SAS programming experience working with large complex administrative healthcare claims databases * Extensive knowledge of SAS/Base, SAS/Macro, and SAS Stat modules * Experience with SQL programming is preferred. * The ability to write efficient and maintainable code in a fast-paced consulting environment is a must, as are good analytical, oral, and written skills.
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REGULATORY AFFAIRS Manager: Job Code C-10
MISSION STATEMENT:
The Regulatory Affairs Manager develops strategies for worldwide governmental approval to introduce new products to market, provides advice on regulatory requirements, prepares worldwide submissions and negotiates their approval. The incumbent also assists with the training of less senior regulatory affairs personnel and provides work direction on projects of large scale.
RESPONSIBILITIES:
* Prepare FDA and international submissions for new products and product changes as required to ensure timely approval for market release. Negotiate submission issues with agency personnel.
* Prepare regulatory strategies/plans and worldwide requirements lists. Provide on-going support to product development teams for regulatory issues and questions.
* Provide support to new and currently marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for FDA and support other international agencies as required by product status.
* Negotiate directly with the FDA on all projects/products at the group level.
* Maintain and direct activities associated with the Field Assurance Department.
* Develop strategies on how to interact more effectively with government agencies and agency personnel.
* Maintain Regulatory Affairs product files to support compliance with regulatory requirements.
* Manage Regulatory department personnel, provide training and support to newer members of the department, and internal teams.
* Assist with conducting facility inspections by regulatory agencies.
QUALIFICATIONS
* Bachelor's Degree in science, math or engineering discipline. An advanced degree is preferred.
* Regulatory Affairs Certified
* Thorough knowledge of FDA, EEA and other international regulations pertaining to the design, manufacture and commercialization of medical devices.
* Requires 6-10 years disposable medical device industry experience at least 2 of which must include direct supervisory experience.
* Demonstrated proficiency with worldwide regulatory planning/strategy & submission planning / preparation
* Effective oral & written communication, interpersonal & influencing skills.
* Ability to communicate across division / corporate / international lines at all levels
* PC skills, word processing, spread sheets, project management etc.
REGULATORY AFFAIRS MANAGER: Job Code C-11
DESCRIPTION:
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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