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Introduction to Ruderfer & Associates, Inc.
Ruderfer & Associates is an executive search firm headquartered in Verona, New Jersey. With over fifty years of search experience we are able to source all disciplines within the Pharmaceutical, Medical Device, Allied Healthcare and Consumer Products industries including: executive management, physicians (clinical research, clinical development, medical affairs and pharmacovigilance), regulatory affairs and legal, research & development, project management, marketing (marketing, payer marketing and market research), licensing/business development/acquisitions, human resources, quality assurance and quality control, manufacturing, finance and sales management. All of our recruiters are alumni of the biopharmaceutical industry and are experienced and sensitive to your needs. It is our philosophy to treat all candidates as we would have wanted to be treated when we were on your side of the desk. Thus, while we maintain a database of over 55,000 candidates - a rich resource to start a search - we will never present a resume to any company without the explicit approval of the candidate. In addition, any recommendations or referrals are kept completely confidential unless we are directed otherwise. This is important to you the candidate and to our clients.
In summary, Ruderfer & Associates’ ongoing relationship with the companies and candidates we represent has cemented a well-founded reputation of excellence based on mature decision-making and professional integrity. We look forward to meeting and working with you.
Our Current Opportunities
Updated 07/26/2023
Regulatory Affairs
NEW – Regulatory Global Labeling, Director/Sr. Director Strategic Global Labeling – #2487 – California/Remote – This position is a strategic leadership role working with a team to develop and manage labeling for products worldwide. Responsibilities may include developing labeling content and strategies for Target Product Labeling, Company Core Data Sheets, Prescribing Information, Patient Labeling, and Instructions for Use. This role will be responsible for strategic regulatory labeling HA interactions and negotiations for labeling projects assigned. Minimum 10 years of industry experience required; 4-6 in labeling. Science based BS or MS required.
Regulatory Affairs Manager – Drug Development – #2472 – Northern NJ/Hybrid – This position reports to the VP, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulatory filing documents, manage documentation systems and maintain interactions with regulatory agencies. Scientific degree or related discipline, adv. degree preferred. 5+ years in pharma and at least 3 years of RA CMC exp. with US Product Development is required.
Regulatory Affairs – Global Development Projects, Director – #2369 – Northern NJ – Our client is seeking an experienced, energetic, results oriented individual to join their US Regulatory Affairs & Global Development Projects Team and be responsible for managing, designing and implementing the U.S. regulatory strategy as part of a global group. Their goal is the successful development of clinical-stage programs for the Company’s pipeline products -- while also offering guidance on ex-US regulatory strategy and filings. M.S. in science related field, 9+ years of pharma exp. in drug or biologics development. MUST HAVE thorough knowledge of FDA and Global regulatory requirements and exp. with NDA submissions.
US Regulatory Affairs – Global Development Projects, Associate Director/Sr. Manager – #2323 – Northern NJ – The Associate Director - Global Development Projects will work with senior members of the US Regulatory Affairs staff to develop Regulatory Strategy and Process Improvement initiatives. Will participate in development program planning and execution, study teams, and study-related activities; preparation of components of IND and NDA submissions including regulatory correspondence, and completion of submission documents. BA/BS in science related field, MA/MS preferred. 6+ years of pharma exp. with 4 yrs in clinical development operations and regulatory positions required.
Quality Assurance
Director/Senior Director, Quality – #2479 – Fort Worth Area, TX – Our client is looking for a hands-on, senior level Quality and Regulatory expert to do all the day-to-day wiring procedures as well as gather data for those procedures. This role covers both Quality and Regulatory Affairs. Incumbent will have 6-7 direct reports.
Director, Head of Clinical Quality Assurance – GCP/GLP – #2473 – Northern NJ/Hybrid – This position reports to the CEO of the parent company. Regular specific interaction also occurs with the President and CEO of the USA Division. The Clinical Quality Director leads all GxP (GCP mostly) audits/inspections at the US Affiliate.
Medical Affairs /Data Management/PVG/Clinical Research /Clinical Operations /R&D /Project & Program Management
NEW – US Medical Affairs, Medical Director – Alzheimer’s Disease – #2389 – Northern NJ/Hybrid– Under the direction of the Senior Medical Director, this role will be responsible for working with key stakeholders to develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area. MD with board certification in neurology and 5+ years’ experience in medical affairs within the pharma industry including 3+ in-house Medical Affairs role.
Principal Statistical Programmer (Pharma) – #2486 – Northern NJ/Hybrid – Our client’s growing Biometrics Group seeks a Principal Statistical Programmer to provide programming support for the statistical analysis and database management. Incumbent will assist with strategies, policies, and standards; and as needed, will run the statistical tables, listings and figures. BS or MS in Computer Science or Biostatistics; 6+ years of industry experience in Statistical Programming (CRO deliverables oversight).
Drug Development Project Management, Senior Director – #2484 – Northern NJ/Hybrid – The qualified candidate will manage assigned project (s), including program’s strategic direction, integrated project plan, alliance management, cross-functional deliverables as required by the International Project Team in the Alzheimer’s Disease and Brain Health Group. This role requires interaction with, and management of, internal crossfunctional team members, business partners, and contractors. Advanced degree is preferred (MS or PhD). 12 years’ exp. in the biotech/pharma industry in phase 2-3 drug development.
Associate Director/Director, Clinical Research Strategy & Design – Oncology – #2480 – Remote – This position reports to the SVP, Head of US Clinical Trials. This position will work closely with team members of different functional groups to ensure flawless execution of study start-up activities, study oversight, and reporting of the assigned clinical studies. Phase I-III clinical strategy and design experience preferred. Oncology and large molecule experience highly desired. Position will be filled at level commensurate with experience.
Executive Director, Head of Global Clinical Development – #2474 – Northern NJ/Hybrid – This position reports to the VP, COO. The Executive Director, Head of Global Clinical Development oversees all clinical trials and provides the overall leadership regarding the scientific and clinical strategy for the portfolio and is accountable for meeting all clinical objectives for the department.
Government Affairs
Director, Policy – #2488 – Washington DC/Hybrid – The primary responsibility of the Director of Policy is to support the Company’s engagement with the Centers for Medicare and Medicaid Services (CMS) to secure appropriate access to the Company’s products by Medicare beneficiaries. In addition, the Director will serve as an internal expert on Medicare Part D policy, Inflation Reduction Act implementation, drug pricing policy, and pharmaceutical industry-directed legislative and regulatory proposals. 8 years biopharmaceutical experience, in government affairs, legislative or public health policy.
Market Access and HEOR
Epidemiology and Real World Evidence, Director – #2457 – Northern NJ/Hybrid – The Director Epidemiology, a member of the Company’s Global Epidemiology and Real-World Evidence (GEE) team, is responsible for generating real-world evidence using fit-for-purpose data to support global products at each stage of the product lifecycle with stakeholders. Infectious Disease TA background preferred. Ph.D/Pharm.D. required.
Commercial Analytics, Business Analytics and Market Research
Head, US Digital/NPP Analytics – #2471 – Northern NJ – The Head, US Digital/NPP Analytics within the Company’s Commercial and Market Access Insights & Analytics organization will be leading this function. This role requires experience measuring, mining, and generating insights from digital customer engagement data within all digital channels, including website, paid media, social media, and email campaign data sets. At least 10 years of applicable full-time work experience with at least four years in digital marketing analytics and optimization.
Finance/Accounting
Finance and Accounting Manager – #2482 – New York Metro Area – This individual ensures that reports, filings, and documentation comply with company's regulations, professional standards, and SEC and GAAP reporting guidelines. This individual will also have exposure to FP&A assisting with budgeting, forecasting and analysis. BA/BS in accounting; CPA required. 5+ years of Public Accounting and Private Industry accounting experience. Big 4 or National Firm Audit experience.