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| Johnson & Johnson Family of Companies |
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CA |
11/19/2009
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| Associate Director, Regulatory Affairs (Santa Barbara, CA) |
| A minimum of a BA/BS degree and RAC certification are required; an advanced degree is strongly preferred. A minimum of 5 years experience in a senior Regulatory Affairs and/or CMC role within Biotech and/or Pharmaceuticals is required. Regulatory Project Management experience is required. Experience in biologics is required. Experience in preparing BLAs in eCDT format is required. Strong knowledge of regulatory requirements (21 CFR Parts 312, 600, 601, 610 and 820) and CMC experience are required. Experience selecting and managing outside vendors is required. Experience processing electronic submissions is required. Global experience is preferred. Travel approximately 25%, but can go up to 80% during peak times with regular travel to manufacturing facility in Madison, WI. PMP certification is preferred. |
| Johnson & Johnson Family of Companies |
South San Francisco |
CA |
11/19/2009
|
| Senior Clinical Budget Analyst - Janssen AI, LLC |
| A Bachelor's Degree is required. Working knowledge of the clinical development process and 2+ years of experience in clinical budget development and management are required. Must possess an understanding of clinical trials, regulatory affairs, quality assurance, clinical trial materials, budgeting and routine contracts. Previous experience with industry benchmarking database(s) is strongly preferred. Excellent communication skills (both oral and written) are required. The ability to work effectively in cross-functional teams is required. Strong and proven negotiation and problem resolution skills are also required. Strong business acumen and an innovative spirit are required. Strong inter-personal and collaboration skills are required. Must possess the ability to accomplish substantial tasks with minimal supervision. Experience in assisting and drafting of legal contracts and familiarity of clinical budget development and negotiation is required. |
| Johnson & Johnson Family of Companies |
Diamond Bar |
CA |
11/19/2009
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| Project Manager, Regulatory Affairs (Diamond Bar, CA) |
| A minimum of a Bachelor's degree in Engineering, Physical or Biological science is required. An MS/Advanced degree is preferred. A minimum of 5+ years experience in the medical industry (Medical Device or Pharmaceutical) is required. A minimum of 5+ years experience in Regulatory Affairs or Quality Assurance of Medical Devices is required. Previous experience with global regulations and regulating agencies is required. Experience developing 510K submissions is required. Experience developing PMA submissions for class III medical devices is highly preferred. Prior experience developing IDE submissions is preferred. Experience conducting submission negotiations with the FDA, including pre-submission identification of requirements and strategy and post submission negotiations is required. Previous experience in labeling and promotional material review is a plus. This position will require 10-15% international and domestic travel. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! |
| Johnson & Johnson Family of Companies |
Jacksonville |
FL |
11/19/2009
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| Manager Clinical Affairs |
| A minimum of a Bachelor's degree is required with a minimum of 8+ years of experience in the Clinical Research of medical devices or pharmaceuticals, or 12+ years equivalent work experience in the Clinical Research of medical devices or pharmaceuticals. Pharmaceutical specific experience is preferred. A degree in a science related discipline is preferred. Supervisory responsibilities or experience is an asset. Complete understanding and application of principles, concepts and practices of clinical research procedures will be required. Knowledge and experience with Good Clinical Practice (GCP) is required. Experience working with Regulatory Agencies is required. Opthalmic experience is an asset. Strategic and tactical Clinical and Business knowledge to gain approval and ensure maintenance of legal marketing status of all products will be required. Strong communication, organizational and interpersonal skills are needed. Broad based technical knowledge and skills in diverse areas of business (e.g. R&D, Operations, QA, laboratories, marketing, etc.) are an asset. Ability to effectively negotiate and influence peers, affiliates and Regulatory agencies to ensure that regulatory and business needs are met will be needed. Must have flexibility to provide innovative approaches to gain marketing approvals globally. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! |
| Johnson & Johnson Family of Companies |
Cincinnati |
OH |
11/19/2009
|
| Quality Systems and Compliance Specialist |
| Minimum of a BS or BA in Business, applied Sciences, Quality or an Engineering-related discipline or equivalent work experience is required. CQA certification is strongly preferred. CQE and/or CRE Certification is also preferred. A minimum of 7+ years of total work experience in Regulatory Affairs and/or Quality Assurance in a medical device or pharmaceutical environment is required. Strong auditing skills are required. Experience managing or participating in internal audit programs is also required. Strong Project Management skills, excellent verbal and written communication skills, influencing management skills are required. Knowledge of ISO-GMPs is required. Knowledge of GLP, GCP Quality Systems and international requirements is preferred. Knowledge of design and development, labeling and manufacturing systems is required. Knowledge of continuous improvement principles is preferred. Experience and/or interactions with a Regulatory agency is preferred. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Johnson & Johnson is committed to diversity and invites all interested candidates to apply for positions of interest. EOE M/F/D/V Please note: In order to be considered eligible for an interview, candidates must apply online through the appropriate web portal. |
| Johnson & Johnson Family of Companies |
Somerville |
NJ |
11/19/2009
|
| Regulatory Affairs Specialist |
| A minimum of a Bachelor's degree in Biology, Biochemistry, Immunology or a related discipline is required. A PhD degree in Biology, Biochemistry, Immunology or a related discipline is strongly preferred. A minimum of 2+ years experience in Regulatory Affairs required. Experience or exposure to the field of Biologics is required. Medical Device and Pharmaceutical experience is an asset. US Regulatory experience is required. EU and International Regulatory experience is an asset. Previous experience in regulations and submitting files for health authorities in Israel is an asset. Excellent communication skills will be necessary for this role. This position will require 10% travel and will be located in Somerville, NJ. |
| Johnson & Johnson Family of Companies |
South San Francisco |
CA |
11/19/2009
|
| Senior Clinical Contract Analyst - Janssen AI, LLC |
| A Bachelor's Degree is required. A certificate of completion of formal course in Paralegal studies is preferred. Certification of Notary Public is a plus. Working knowledge of the clinical development process and 2+ years of experience in clinical budget development and management are required. Must possess an understanding of clinical trials, regulatory affairs, quality assurance, clinical trial materials, budgeting and routine contracts. Excellent communication skills (both oral and written) are required. The ability to work effectively in cross-functional teams is required. Strong business acumen and an innovative spirit are required. Strong inter-personal and collaboration skills are required. Must possess the ability to accomplish substantial tasks with minimal supervision. Familiarity of clinical budget development and/or negotiation is required. |
| Johnson & Johnson Family of Companies |
Taunton |
MA |
11/19/2009
|
| Manager, Clinical Research |
| Minimum of a Bachelors degree in Science or related Health Field is required in this role with a Masters Degree in Science/related Health Field preferred. Also preferred is an, MBA. 10 years industry experience with 7 years experience in the Pharmaceutical or Medical Device industries is required. Strong leadership skills and the ability to develop successful strategies while fully understanding the complex environment of the assigned program. Experience in multiple functional areas strongly preferred (Clinical, Marketing, R&D, Sales)Significant project management experience with cross-functional, cross-company and international project teams. Clinical trial experience is strongly preferred and international trial experience is a plus.Strong ability to communicate clinical information (concepts and results) in oral and written communication to experts (e.g., KOL, FDA reviewers) and to product development team members (e.g., clinicians, marketing personnel, engineers)Understanding of the contribution of scientific and medical affairs goals to company business strategiesExperience drafting or reviewing technical documents (e.g., Clinical protocols/reports, design FMEAs, IOVVs). Appropriate knowledge of GMP, GCP and regulations required.Proven insight into the integration of science, regulatory, and business principles as it pertains to the successful development of multi-center clinical studies.Understanding of reimbursement landscape in the US and OUS is beneficial.Prior experience in strategic roles, along with excellent written and oral communication skills, and experience presenting to senior management also required.Ability to foster a strong collaborative team environmentDemonstrated ability to collaborate and work effectively in a fast-paced matrix environmentDemonstrated negotiation and conflict resolutions skills, including the ability to influence without clear reporting authorityStrong professional diplomacy Strong organizational skills (e.g., able to manage multiple institutions and/or projects). If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! |
| Johnson & Johnson Family of Companies |
Somerville |
NJ |
11/19/2009
|
| Manager, Regulatory Affairs |
| A minimum of Bachelor's degree in a technical, scientific, or medical/health discipline is required. An advanced degree is an asset. A minimum of 8+ years experience in a regulated healthcare industry is required. Direct experience in Regulatory Affairs is required. Experience with or exposure to 510(k) submissions is required. US regulations knowledge is required, with EU and International/OUS experience an asset. PMA experience is an asset. Copy review experience is an asset. RAC is an asset. Excellent verbal and written communication skills will be needed. The ability to influence and negotiate with business partners and regulatory agencies will be required. This position will be located in Somerville, NJ. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! |
| Johnson & Johnson Family of Companies |
Somerville |
NJ |
11/19/2009
|
| SENIOR DIRECTOR, REGULATORY AFFAIRS |
| A minimum of a Bachelor's degree in a scientific discipline is required, with an advanced degree is strongly preferred. A minimum 10+ years of experience in regulatory affairs or a related field is required. RAC is an asset. Direct experience with US/EU regulatory submissions is required. PMA experience or experience with PMA products is an asset. Experience successfully taking a product through development and regulatory cycle required. Proven leadership and strong people management skills will be needed. Successful track record in coordinating and experience with interacting with multiple and diverse business units required. Excellent oral and written communication skills required. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! |
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