Medical Director (Clinical Development) 2 Positions
Central, NJ

Design, implement and complete high quality clinical trials that support company objectives. Anticipate future changes to health care delivery, regulatory policy and the marketplace, taking action now which creates long term opportunities. Develop, with Business organization, sound medical scientific messages about our products for consumers physicians and other customers.

Medical Science Liaison
San Fransisco, CA

Primary focus on interfacing with field operations and opinion leaders. Possesses the scientific knowledge and professional demeanor necessary to earn the respect of both external and internal constituents. Has an established track record of effective and influential speaking engagements with medical professionals. Has published a significant therapeutic research or has substantive patient care experience. Has experience positioning particular drug therapies and has a track record of influencing others to make accurate and effective therapeutic decisions. Is able to work effectively with internal and external multidisciplinary teams in developing strategies and implementing tactics.

Medical Director
Eastern, PA

The medical Director is a senior medical writer who is delegated the responsibility and authority for content quality oversight of a business unit. The Medical Director is responsible for reviewing all project- or client-related content for message accuracy and consistency. The Medical Director will work closely with other members of the business unit to develop and maintain strong client relations.

CORE COMPETENCIES
Team Building
Team focused. Encourages and sets an example for cooperation, creating trust and working toward common goals and values. Creates interdependence of effort rather than building walls.
Multitasking
Able to adapt to changes in plans and priorities and exercises good judgment about what is important. Consistently manages tasks to completion within deadlines.
Crisis Management
Able to identify important and critical issues in the context of overall priorities. Balances poise and a sense of urgency. Within the context of the business strategy and objectives, works to identify and eliminate factors creating the crisis and to minimize recurrence.
Collaborative Problem Solver
Listens first and seeks to understand others. Values differing views and opinions as a potential source of better decisions and solutions. Focuses on solutions rather than placing blame. Where necessary, seeks consensus and offers compromise solutions.
Driving Continuous Improvement
Seeks ways to work smarter and is willing to offer and accept alternatives. Thinks innovatively and facilitates learning from successes and failures.

Director of Biostatistics
Eastern PA

Job Responsibilities:
Will train and supervise (staff of 5 or so) statisticians and programmers. Will coordinate projects and assign them accordingly to statisticians in a timely fashion. The incumbent will serve as the primary contact with sponsors and work with business development personnel in establishing industry contacts and developing bids. This individual will also maintain all responsibilities of a senior statistician. Will work and coordinate with supporting departments. Will be involved in the decision process when hiring new statisticians, taking part in the bid process, establishing SOPs and standard algorithms. Serves as intermediary between statisticians and other company personnel.

Job Requirements:
Masters degree in statistics with at least 15 years of appropriate industry experience, or Ph.D. in statistics or a closely related field and at least five years of industry experience. Knowledge of FDA guidelines and procedures and experience in communicating with the FDA is required.
Skills and Knowledge Development
•Statistical expertise of a senior biostatistician.
•Understanding of company policies.
•Presentation skills for new sponsors and the FDA.
Competencies Demonstrated
•Competencies of a senior statistician.
•Ability to manage statistical group and interact with current and potential sponsors and the FDA.
Criteria for Performance Assessment
Difficulty of assignments, accuracy of results, speed of completion, and quality of interaction with co-workers, sponsors, and the FDA.

Senior Medical Writer
Easterm, PA

Description:
Assumes primary responsibility for direction, scope, and organization of the specific document being prepared, in conjunction with statistician and medical monitor guidelines provided by individual sponsors; maintains schedule for timely preparation of document.
Requirements: Writes clear and concise clinical documents, including clinical study reports, appropriate sections of INDs and NDAs, summary documents, and annual updates. Contributes to statistical output plan concerning organization and table layout for a specific document. Excellent writing skills. Working knowledge of template use for document creation; ability to work with different template styles and types. Knowledge of ICH Guidelines and FDA regulations concerning document preparation. Ability to understand and interpret clinical and scientific data; ability to present results in a straightforward and understandable manner. Excellent interpersonal and oral communication skills. Ability to work independently.
Education: Bachelor’s or master’s degree, preferably in a biological science; RN, PharmD, Ph.D. or M.D.

Experience:
Minimum 3+ years clinical\medical writing experience in a clinical/pharmaceutical organization. Understanding or experience with clinical trials and drug development process.

Clinical Project Manager
CT

Strong, professional leadership skills required to carry out full management of clinical projects. Responsibilities will include management of multiple clinical studies, protocol & CRF design, monitoring & reporting of project timelines, budget development, contract negotiations, site management, training and mentoring of junior staff members. BS/MS preferred, plus at least 3 years experience in project management and leadership role.

Competitive salary, plus full menu of benefits including medical, dental, vision, life, disability, 401k with company match, and stock options.

Travel: Maybe 10-20%

Senior Research Scientist
Northern, NJ

Responsible for managing key studies at academic institutions and contract research organizations, including establishing appropriate legal/contractual agreements, drafting and reviewing protocols, visiting sites to monitor studies when needed; analyze data and review study reports. Identify research activities, as appropriate, to expand understanding of the mechanism of action and activity of Companies compounds. Review and provide updates on status of important cardiovascular and renal research in the academic and industrial community. Provide key input into the design of GLP and non-GLP cardiovascular and renal toxicology studies. Manage the technical relationship(s) between Companies and external vendors in the above areas. Manage the operational and capital budgets for the research area, working closely with Finance to effectively manage the contract and grant payments. Maintain effective communications with Company senior management.

Requirements: Minimum of 7-10 years with experience in broad-based research in cardiovascular, renal and/or diabetes physiology (pharmacology, biochemistry or molecular biology or related discipline). Ph.D. in cardiovascular or renal physiology, pharmacology, biochemistry or molecular biology with post-doctoral experience, and at least 5-7 years of industry experience (or 7-10 years industry experience without post-doctoral experience); or M.S. with industry experience (at least 7-10 years strongly preferred). Minimum of 7-10 years active research involvement in two or more of the following areas: models of hypertension, heart failure, endothelial function, models of renal function; background in physiology, pharmacology, biochemistry or molecular biology. Strong analytical, organizational, communication, interpersonal and implementation skills. Ability to proactively plan research programs in conjunction with external academic or contract investigators. Ability to make decisions and competently implement the most effective plans.

Clinical Team Manager
Northern, NJ

Responsibilities include coordination of clinical trial activities, both U.S. and International; line management of junior level CRA’s; coordination of activities between internal and external functional groups; reviewing and approving monitoring reports; assisting Director in systems development and overall departmental procedures, processes and policies and in establishment of departmental quality controls; leading departmental and individual meetings; demonstrating an effective open door communication policy.

Requirements: Minimum of Bachelor’s degree in a scientific field, MS in relevant discipline preferred. Knowledge of medical, scientific and clinical research aspects of pharmaceutical trials. Knowledge and experience in clinical trial design, analysis and reporting. Advanced clinical/pharmacology training preferred. At least 10 years progressive experience in clinical operations within pharmaceutical or CRO industry. Excellent knowledge of FDA and ICH guidelines. Clinical or patient care background preferred. Worldwide clinical project lead experience including coordination of vendor activities and international clinical teams. Effective oral and written communication skills and computer literacy a must. Experience with EDC a plus. Excellent interpersonal skills, motivated; strong communication skills; proven ability to work in a small company environment.

Senior Clinical Research Associate II
Northern, NJ

Responsible for coordinating and supervising all aspects of implementing and conducting clinical studies in accordance with FDA regulations and GCP/ICH guidelines; contributing to the development of protocols and CRFs; ensuring protocol compliance across all sites; participating in site selection, initiation, monitoring, and closure activities; generating clinical project plan including timeline projection and monitoring strategy. Ability to function as a project manager coordinating multi-functional project teams, may be involved in budgeting and contracts; reviewing CRA trip reports and correspondence; preparation and implementation of project-specific training programs and presentations for internal and external clinical team; providing leadership, guidance and mentoring to clinical team; maintaining awareness of developments in the field of clinical research, GCP, and therapeutic area; making recommendations regarding monitoring safety, eligibility, enrollment and data consistency; organization and participation in investigator meetings, including presentations.

Requirements: BS/BA/RN/pharmacy degree. Minimum of 5 years experience in clinical research or clinical trial monitoring. ACRP Certification as Certified Clinical Research Associate preferred. Clinical experience in a pharmaceutical company strongly preferred. Proficient in FDA regulations and GCP/ICH guidelines. Knowledge of medical, scientific and clinical research aspects of pharmaceutical trials. Knowledge and experience in clinical trial design, analysis and reporting. Advanced clinical/pharmacology training preferred. Demonstrated ability to write protocols, CRFs, and clinical trial reports independently. Interface with investigative sites and recognize safety and efficacy data trends. Mentor and support clinical research staff. Effective oral and written communication skills. Computer literacy a must. Self-motivated and positive team player, adaptable. Willing to travel 25-50% of the time.

Oncology Clinical Specialist
TN

The Clinical Specialist’s primary responsibility is to support demand creation by delivering medical education programs and clinical support to nurses and other medical professionals as clinically directed by Clinical Specialist’s leadership and deployed by District Managers. Employees will be the principal clinical resource to customer and field staff and will work in partnership with Professional Sales Representatives and Health System Managers as applicable. (Primary customers include nurses and secondary customers include physicians and pharmacists.) Additional responsibilities include providing support to PSR with Office Managers, Buyers, and Reimbursement Coordinators. Employees will affect territory sales by executing a Plan of Action (POA) marketing strategy, which involves executing continuing educational programs, providing clinical support, and providing guideline reviews and recommendations. Clinical Specialists will also be responsible for executing market development programs (e.g., patients, nursing societies), collaborating with marketing in the review of educational material, and developing territory plans with District and Regional Clinical Managers.
Requirements: Bachelor''s Degree and RN or Health Care Certification or the equivalent combination of education and experience required. Nursing Certification in applicable field preferred. Typically 3 to 5 years health care related industry experience in assigned field also required. Previous experience in positions such as Clinical Nurse Specialist, BMT Coordinator, Clinical Trials Coordinator, and Health Care Administrator necessary. Candidates should demonstrate clinical/medical expertise, effective partnership with sales force, and excellent communication and presentation skills. Local Market knowledge is also preferred. This position also requires driving and extensive travel (travel may vary by product or business unit).

Group Leader, Pathology
CT

Relocation is available
Primary Responsibilities:
Primary responsibility of the Group Leader is to lead Pathology effort in the development of novel protein therapeutics and fully human monoclonal antibodies for the treatment of unmet medical diseases. The candidate will have responsibility for the execution and coordination of experiments leading to the evaluation of pathology specimens from toxicology, in vivo efficacy and research studies. The candidate will also have responsibility for coordinating tissue and sera acquisition to support internal research efforts. The candidate will interact on project teams and with outside contractors. Strong interpersonal and written skills are essential for the successful applicant.
Preferred Qualifications:
Applicants are required to have a PhD, DVM or MD and Board Certification or Board eligible in Pathology. Experience with morphometric techniques, immunohistochemistry and in situ-hybridization procedures is desired.

Sr. Regulatory Affairs Associate
Northern, NJ

Will be responsible for analyzing designing and drafting submissions to domestic and international regulatory agencies in order to obtain approval for new products and/or new indications and claims for existing product lines. Responsibilities will also include evaluating promotions and clinical education material for conformance to current regulations and procedures of US and International regulatory agencies as well as representing Regulatory Affairs on new product development teams.

Requirements:

Bachelor degree and approximately 7 years experience in regulatory affairs, good working knowledge of US and European regulations, policies, and guidance’s regarding promotion and advertising of medical devices. Qualified candidate will also have strong interpersonal communication skills, strong analytical and writing skills necessary for developing and drafting analyses, organizational skills, detail oriented and the ability to travel domestically on occasion.

Quality Engineer
Northern, NJ

Will be responsible for Conducting process and product validations and audits, including; developing procedures, tests, sampling plans, statistical designs and collecting/analyzing data. Providing statistical and technical support for all company disciplines and preparing Quality reports for management review.

Requirements:
B.S. Degree in Engineering or related science with 3 to 5 years experience in Quality Assurance or Quality Engineering, preferably in the medical device field. Knowledge of QSRs and FDA requirements as well as experience with statistical process control and design of experiments. Candidate must have strong compliance and statistical experience, strong knowledge of the medical device field and a certified QE is preferred

CLINICAL MANAGER
Eastern, PA

•Assist the Project Manager in the development and review protocol/study design, case report forms, informed consent forms and other documents.
•Participate in the identification and recruitment of investigators. Develop patient recruitment strategies and materials.
•Coordinate Clinical Monitors on-site and in-house monitoring responsibilities and schedules.
•Manage aspects of the clinical projects including development of the CMP and review and sign-off of monitoring reports. Assist in preparation of the monthly status report.
•Prepare source documentation and assist in generation of CRF guidelines.
•Identify, recruit and manage central lab, ECG, ABPM, drug labeling, packaging and distribution, Holter, IVRS as required.
•Ensure PR-SCP master files comply with SOPs, GCPs and other regulations.
•Design and develop investigator, regulatory, operations, guidelines and training manuals.
•Prepare for and attend project launch meetings.
•Assist in the preparation and development of materials for the Investigators' Meeting. Attend Investigators' Meeting and present assigned topics. Serve as the primary clinical representative to investigative site research staff.
•Attend and participate in internal and external training sessions
Requirements:

•Position requires 25% travel.
•Good presentations skills are required.
•Knowledge of medical terminology, clinical pharmacology and pathophysiology is required.
•Demonstrate good working knowledge of the drug development process, Good Clinical Practices, International Committee on Harmonization Guidelines and federal regulations pertaining to clinical research investigations.
•Demonstrated leadership and mentoring skills desired.
•Bachelors' degree (BS, BA, RN) in a biological- or science-related field required.
•Experience with three (3) to five (5) therapeutic areas required. Primary therapeutic focus: Oncology i.e. solid tumor, hematological malignancy, breast cancer.
•Three (3) to five (5) years of clinical monitoring experience.
•Three (3) to five (5) years experience with Phases I - IV clinical trials.
•Three (3) to five (5) years of clinical experience in the pharmaceutical, biotechnology or CRO industry or equivalent is required.

Regulatory Affairs Manager
San Diego, CA

Provides regulatory advice and guidance to operational product teams to ensure regulatory programs and submissions meet domestic and international regulatory requirements, and information is submitted in a timely fashion.

RESPONSIBILITIES:
Prepare regulatory submissions for U.S. FDA and international health authorities. Liase with domestic and international health authorities.
Assist in defining and establish regulatory strategies for new product development efforts.Work closely with Research, CMC and Clinical Development from the initial process of defining regulatory requirements and strategies to the final approval of reports and their inclusion in the regulatory submission documentation.
Function as regulatory team member on multiple project teams.
Manage multiple, sometimes conflicting priorities.
Manage the activities of Regulatory Associates in the conduct of their duties; Participate in the management of the Regulatory Affairs Department; Experience in Regulatory/Compliance in Non clinical, CMC and clinical issues.
MINIMUM QUALIFICATIONS:

BS/BA in a life science preferred plus a minimum of 5 years of pharmaceutical/biotech regulatory experience is required. Previous management experience preferred.
Hands-on experience in filing and maintaining NDA's, IND's, and experience in team leadership is preferred. Experience with electronic submissions is a plus.
Thorough knowledge of U.S. regulatory environment required, knowledge of international environment strongly preferred.

SR. MANAGER QC SERVICES
San Diego CA

Responsibilities:
QC professional needed to lead and drive the efforts of the Company’s Quality Control department. Position will include the direction, supervision and conduct of all laboratory operations. Responsibilities will include directing the QC laboratory operations responsible for stability programs, Environmental Monitoring and training, and, for the commercial testing and release of drug substance, intermediate bulk, and finished drug product. Incumbent will be responsible for the overall regulatory compliance profile and documentation systems within laboratory operations.
Successful candidate will interface with manufacturing development functions to provide analytical services in support of transfer and validation activities required to ensure successful commercialization. Interface with PPD disciplines also necessary to provide analytical services in support of materials characterization and methods development, transfer and validation for new product initiatives. Will need to proactively collaborate with Regulatory, Development and Operations functions to meet CMC deliverables and achieve timely regulatory approvals; will also participate in cross-functional teams as required to meet relevant clinical supply requirements, and manage key analytical deliverables. Managing the departmental budget and setting short-and log-term department goals also a key responsibility.

Requirements:
Requirements include a B.S. in a chemical or biological discipline plus 10+ years experience in pharmaceutical, biotech operations with thorough working knowledge of regulatory guidelines, and cGMP practices including 5 years QC management experience in a commercial parenteral / biologics company. Experience in achieving regulatory approval with product specifications harmonized across multiple markets, and experience with successfully launching/supporting new products.
Extensive industry experience with familiarity of environmental monitoring, sterility, endotoxin and bioburden testing. Extensive knowledge and expertise in QC, including Analytical Chemistry, Stability and Microbiology. The demonstrated ability to manage scientific personnel and encourage teamwork. Excellent communication skills and the ability to work collaboratively across departments.

Clinical Project Manager (Oncology)
Central, NJ

The successful candidate must have two years of demonstrated, prior clinical project management experience. Prior oncology experience preferred. Doctor of Pharmacy degree preferred or combination of Bachelor of Science in related field and clinical research experience.

In addition, the successful applicant must have demonstrated knowledge of protocol and analysis plans as well as knowledge of GCPs. Proven project management and leadership abilities a must. Demonstrated decision making and problem solving skills required. Excellent communication and writing skills are essential.

Key responsibilities include leading the project team and coordinating all project components: i.e. site contact, data management and clinical study monitoring. In addition, the successful candidate will serve as a primary contact person for assigned projects and act as a mentor to clinical staff on a project specific and general basis. 30-50% travel throughout North America is required.

The Company offers an excellent compensation package, which includes comprehensive health coverage (medical, dental, and vision), liberal vacation and pension plans, disability and life insurance, as well as, tuition reimbursement.

Sr. Product Manager (Marketing)
Northern NJ
For Medical Device Company. Looking for approx. 3-5 yrs prior Marketing exp. prefer in Medical Device

Product Development Engineer
Northern NJ

·LOOKING FOR SOMEONE WITH APPROX. 3+ YEARS OF PRODUCT DEVELOPMENT EXP. IN DRUG DELIVERY SYSTEMS. (TRANSDERMAL, STINTS ETC)
·WILL WORK ON PRODUCTS THAT ARE REGISTERD AS MEDICAL DEVICE & DRUGS (PATCH & CONTROL RELEASE)
·WILL BE HANDS ON, COMING UP WITH NEW DESIGNS FOR NEW INNOVATIVE PRODUCTS. (CAD EXP. A PLUS)
·LOOKING FOR FDA EXP. FAMILIAR WITH GMPS & ISO. QSR EXPERIENCE IS A PLUS.
·PRODUCTS THAT THIS PERSON WILL BE WORKING ON ARE TRANSDERMAL PATCHES WITH ELECTRODS. (GIVES A POSITIVE & NEGATIVE CHARGE TO DELIVER DRUG)

QUALIFICATIONS

M/S DEGREE IN SCIENCE (STRONG PREFERENCE FOR ENGINEERING) WITH 3+ YEARS OF EXPIERENCE OR B/S DEGREE WITH 5-6+ YEARS OF EXPERIENCE.

Clinical Research Manager
Central NJ

Directs/supervises CRA staff within a therapeutic area through assignment of applicable clinical study monitoring activities, and other responsibilities intended to gain regulatory approval for drugs/biologics and to provide clinical support for marketing objectives.

Bachelor of Science
BS degree required (life sciences preferred). Min. 10 years related clinical research experience with at least 8 years as clinical study monitor. In depth knowledge of the drug development process required, with demonstrated leadership qualities and previous management experience required