Introduction to Ruderfer & Associates, Inc.
Ruderfer & Associates is an executive search firm headquartered in Verona, New Jersey. With over forty 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 50,000 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
NEW – Regulatory Affairs Strategy – Oncology, Associate Director – #2183 – Westchester, NY – This position involves the ability to integrate/apply knowledge of global regulations governing pharmaceutical drug development of all aspects of the Company’s quality, preclinical and clinical drug development programs, policies and procedures so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements.
NEW – Regulatory Affairs – Advertising and Promotion, Associate Director – #2171 – Westchester, NY – This position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced understanding of advertising and promotion regulations/guidances to the development of key product messages presented in Biologic License Applications (BLAs) and Marketing Authorization Applications (MAAs). Will ensure that messages are translated into advertising and promotion initiatives that meet the commercial team’s objectives, while maintaining the necessary state of compliance and corporate integrity. Advanced degree (MS, PharmD, PhD); 3 – 5 years of Regulatory Affairs experience reviewing promotional materials in pharma industry.
NEW – Regulatory Affairs – CMC Biologics, Associate Director/Sr. Manager – #2170 – Central NJ – This new position will work closely with functional areas and project teams to support regulatory chemistry and manufacturing control (CMC) execution as it pertains to the biosimilar/biologics programs that Global Regulatory Affairs supports. MS or PhD in relevant technical discipline required. Minumum 8 years experience of Regulatory CMC biologics in pharma or biotech industries.
NEW – Regulatory Affairs – CMC, Director – #2168 – Central NJ – This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team, and serves as Integrated Project Team (IPT) ad hoc member for late stage projects. This position will be responsible for planning for development and post marketing projects, execution of strategy and submission, leading health authority interactions, and demonstrating expert regulatory knowledge. M.S. or PhD in a scientific discipline is required along with 8 to 10 years of pharma industry experience. 4+ years of CMC regulatory experience is a must.
NEW – Global Regulatory Affairs, Associate Director – #2167 – Central NJ/Remote – Responsible for developing and implementing and leading short- and long-term global regulatory strategies that support the success of investigational and marketed pharmaceutical products throughout their lifecycle. These robust and expeditious strategies extend from R&D through post-marketing, in accordance with global regulations. Applies regulatory intelligence and expertise to effect innovative regulatory pathways and solutions to complex global requirements. (MS, PhD, PharmD, MD preferred.); 5-7 years of relevant pharma R&D industry experience and/or regulatory affairs. Must have experience in gaining regulatory approval on at least one major marketing application (NDA/BLA/MAA, etc).
NEW – Global Labeling Strategy, Associate Director – #2166 – Central NJ/Remote – Our client is a global healthcare company that researches, develops, manufactures and markets innovative pharmaceutical products for the maintenance of everyday health. This position will lead the preparation, review and update of content for the development and maintenance of labeling and labeling components. BS degree in life sciences, scientific or engineering field required. (MS, PhD, PharmD, MD preferred.); 5+ years of relevant pharma regulatory/labeling experience. Must have solid understanding of global labeling requirements.
NEW – Regulatory Labeling Sr. Manager/Manager – #2160 – Westchester, NY – Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives. Assist in the creation or revision of the labeling SOP or work instructions. BS or MS degree; 5 to 7 years of Biotech or Pharma industry experience required.
NEW – Regulatory Labeling Director/Associate Director – #2159 – Westchester, NY – Manages the development, review, approval, and maintenance of labeling for designated products. Leads the Cross Functional Labeling Team and manages labeling projects for CCDS, USPI, EU SmPC, and local labeling effectively, and independently. Maintains and appropriately archives submitted and approved labeling documents and packaging component labeling. Participates in the development of the labeling objectives early in product development to assist teams in creating development strategies to achieve these objectives. Assist in the creation or revision of the labeling SOP or work instructions. Advanced degree (PhD, PharmD); 10 - 15 years of Biotech or Pharma industry experience required. Must have in-depth knowledge of regulatory labeling process.
NEW – Regulatory Affairs Global Labeling, Senior Manager – #2143 – Allentown, PA – The role is responsible for all Labeling and artwork components to ensure compliance with innovator labeling, internal company, external partners, regulatory and serialization standards and requirements. The incumbent will also participate in a cross-functional Promotional Review Committee to review advertising and promotional materials as necessary to ensure materials are accurate and that they comply with regulatory standards, meet company needs and accurately assess current strategy and global regulations. BS/MS/PharmD in science related field. Must have knowledge of US, EU and Global Regulatory Labeling requirements.
NEW – Regulatory Affairs, Senior Director/ Director – #2140 – NYC/some remote work possible – With oversight from the Head of Regulatory Affairs, this position independently leads the preparation and formulation of strategy for global regulatory submissions in collaboration with cross-functional team members and management. This position acts as the regulatory affairs point of contact for interactions with Health Authorities (HA) and cross-functional team members and may lead team(s) in orchestrating Health Authority interactions. Advanced degree (PhD, PharmD, MD) in science related discipline preferred; minimum 10 years of pharma regulatory experience and 2+ years of oncology therapeutic experience.
Regulatory Affairs, Site Head & Director – #2111– Spokane, WA – Leads the development, implementation, and direction of effective regulatory strategies with oversight for all regulatory functions pertaining to the pharmaceutical, biologics and/or device programs supporting the established business units. This position provides leadership to ensure site expectations are met by providing regulatory vision, strategy and planning relevant to CMC (premarket & post-approval activities), compliance and policy as it pertains to federal/state laws and regulations. Requires bachelor’s degree in science or healthcare; master’s degree in regulatory, business or scientific discipline preferred. Must have pharma biologics experience and FDA regulated industry experience.
Global Regulatory Labeling, Associate Director – #2083 – Northern CA – The Associate Director of REG-GL provides strategic and operational regulatory labeling input to labeling content, submission, production, and implementation worldwide. The Associate Director works in close collaboration with subject matter experts on the Product Labeling Teams (PLT), Global Regulatory sub-teams, and Senior Management Review Teams to ensure the execution of global regulatory labeling plans are aligned with the global regulatory strategy and with our client’s labeling processes and standards. A minimum of 8 years of pharmaceutical or health authority industry experience and at least 3 years experience in global labeling required.
Regulatory Affairs – CMC EU, Director/Associate Director – #2082 – Central NJ – The Director/Associate Director serves as the EU Regulatory Affairs (RA) CMC member for all assigned developmental projects and for life-cycle management of approved product in the European Union. This position executes the EU regulatory strategy and provides regulatory support and guidance to the RA CMC members supporting development projects and life cycle management based upon EU regulatory experience and knowledge of EMA and national guidances. Must have: Master’s degree in scientific discipline; 8-10 years of relevant pharmaceutical experience plus 4 years of direct EU CMC regulatory experience for Associate Director / 10-12 years of relevant pharmaceutical experience plus a minimum of 5 years of direct EU CMC regulatory experience for Director.
Regulatory Affairs Labeling Strategist, Manager – #2071 – Northern NJ – Under direction from managers, this position will undertake the responsibility for preparation, review and approval of labeling to support US pre-approval and commercial efforts. The incumbent will serve as a liaison to the US FDA, internal the company’s cross-functional teams and external third party entities. The incumbent will work closely with the Regulatory Affairs teams to ensure timely and comprehensive support to meet business unit timelines for all submissions containing labeling components. Bachelor’s degree required; must have pharmaceutical regulatory experience with substantial labeling review experience.
Regulatory Affairs – Neurosciences, Director – #2031 – Westchester, NY – Provide leadership on global clinical regulatory activities. Responsibility will mainly focus on clinical regulatory filings and provide strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and BLA submissions activities for the client’s clinical asset candidates.
NEW – Inspection Management, Director – #2164 – Westchester, NY – This position is an integral part of the team that manages inspections through the prep, performance and follow-up of items requested by international regulatory agencies and partner audits. This position directs and manages cross-functional teams in inspection readiness, ongoing inspections, and inspection follow-up for GCP/GPV/GLP inspections by global regulatory authorities. Must have practical experience with inspections. MS/PhD/PharmD plus 8+ years of relevant inspection experience preferred.
QA Engineer – #2114 – Fort Worth, TX – The basic purpose of this position is to provide technical quality assurance resource for all Operations and QA areas. Analyzes existing operations against the requirements of ISO 13485 and 21 CFR: 820 and proposes enhancements in compliance for those operations, to those regulations. Provides guidance on solutions to moderately complex problems. Bachelor’s or Master’s Degree in Engineering, Microbiology, or related field.
Quality Assurance, Director – #2064 – Fort Worth, TX – Lead and manage all QA for established, Medical Devices provider. Must have sterile products experience (Gamma and EtO sterilization as well as sterile packaging); a minimum of 5 years QA leadership experience in medical device environment; knowledge of ISO 13485 and CFR Part 820; proven communication experience with FDA; and 3+ years of supervisory experience.
Medical Affairs /Medical /Clinical Research, R&D, Project Management
NEW – US Oncology Medical Affairs, Medical Director – #2175 – Northern NJ – The Medical Director within Oncology Medical Affairs provides medical leadership for medical affairs strategy, planning and supportive tactics for assigned therapeutic area in Oncology. Under the direction of the Vice President of Medical Affairs, 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. MD with minimum 4+ years’ experience within the pharmaceutical industry including 2 years an in-house oncology Medical Affairs role, or PhD or PharmD with 10 years’ experience in pharmaceutical industry, including 5 years in-house oncology Medical Affairs role.
NEW – Discovery Data Science, Associate Director – #2165 – Northern NJ – The Associate Director, Head of precision informatics including Discovery Data Science and bioinformatics, is a member of the Translational Science Engine within the Oncology Business group. This individual will be responsible for performing, coordinating, and leading hands-on analysis of exploratory and regulatory related biomarker analysis, large-scale genetic and other ‘omic analyses, with a primary goal of identifying and validating targets and biomarkers in preclinical and clinical trials for oncology. MS, Ph.D. degree preferred with 3-5 years of experience in Statistical Genetics, Genetic Epidemiology, Human Genetics, Statistics, or closely related field.
NEW – Medical Safety & Risk Management Physician – Sr. Director/Director – #2161 – Northern NJ – This position serves as scientific safety leader for assigned projects ranging from those in clinical development through submission and post-marketed products. The Medical Safety & Risk Management Physician will assist Head of PSPV and Quality/Compliance Leader to prepare for inspections, and lead CAPAs, initiatives, and SOP revisions/development. MD or DO required with 10+ years of Pharma industry experience in Safety, PVG, and Risk Management.
NEW – Risk Management, Director – #2158 – Westchester, NY – Reporting to Head of Risk Management, will be responsible for RM Lead activities for numerous and complex compounds. Take initiative/assume lead role in across-compound RM activities. Serve as in-house expert on designated RM topics. May assume personnel management responsibilities. Must have clinical experience and 2+ years of drug safety experience including significant experience with PSURs/ DSURs/ (d)RMPS; or in clinical development with demonstrated achievements in safety (ex. supporting an ISS; responsible for CSR content).
NEW – Biostatistics, Associate Director – #2154 – Northern NJ – This position independently reviews whole protocol and interfaces with clinicians and other functions to understand study requirements and study design elements including sample size calculations, analysis methods, study durations etc. for multiple studies. PhD with 5+ years or MS with 10+ years of experience required in related discipline or in the pharma industry/CRO environment.
NEW – Epidemiology Analytics, Director – #2145 – Westchester, NY – The Director accountable for setting up the analytic capability and leading statistical and analytical activities in support of pharmacoepi (PE) projects using internal or external automated healthcare databases or registries.
NEW – Pharmacovigilance – Oncology, Senior Director/Director – #2141– NYC – The company is seeking an MD who is a seasoned Pharmacovigilance specialist who knows how to submit the necessary documents to the various regulatory agencies but also how to interpret and advice senior management. The candidate should have strategic and technical expertise with excellent written and verbal communication skills (to communicate to non-technical senior management) that thrives in a creative, collaborative and engaging environment.
Clinical Research – Oncology, Associate Director – #2127 – Northern NJ – The Associate Director, Clinical Research Scientist will assist the Clinical Lead and/or Study Director in the planning and implementation, execution, day to day managing and reporting of clinical trials. Additional responsibilities include: assisting with the preparation of the clinical trial synopses, protocols, protocol amendments, drug development plans, clinical research forms, Investigator Brochure, Clinical Study Report, etc.; training new CRO monitors and CRAs on protocol and processes; assisting with the preparation of the NDA documents; preparing clinical sections of IND annual safety report and annual Investigator brochure updates; assist with the database cleaning (eligibility listings, patient profiles, listings, laboratory results, etc.); and assisting with the preparation of the publications (abstracts, articles, etc.) pertinent to the study. MD Board Certified or Board Eligible in Hematology and/or Oncology (new entrants to pharma); PhD/PharmD with 5 years of clinical research in pharma preferred.
Pharmacovigilance, VP/Senior Director – #2110 – Northern NJ – Reporting to the Chief Medical Officer (CMO), the VP/Senior Director, Pharmacovigilance, will be a clinically trained physician with accountability for overseeing the medical safety of the Company’s products, working cross-functionally for product safety and benefit-risk management and be able to manage outsourced vendors. This position will represent the company with health authorities for medical safety. In addition, the position will recommend the safety database of record based on review of proven vendors. US-trained Physician (MD or equivalent) with Board Certification; Minimum of 6 years in the pharmaceutical industry with a minimum of 4 years in pharmacovigilance.
Clinical Research (Sleep), Senior/Executive Medical Director – #2106 – Northern NJ – The Senior Medical Director/Executive Medical Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Sleep Disorders therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as an International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials. MD required, Board Certification in a related area preferred. Sr. Medical Director requires: 10+ years in pharmaceutical clinical development/ Executive Medical Director requires: 12+ years in pharmaceutical clinical development with experience directing Neurology Phase 2-3 global multicenter studies.
Clinical Research – Neuroscience, Associate Director – #2103 – Northern NJ – The Associate Director, Clinical Research is a newly created role for a dynamic individual with an PhD with experience in the pharmaceutical industry. The position is intended to provide the organization with as individual to oversee the conduct of clinical studies for Phase 2 and 3 development of compounds targeting dementia and, in particular, Alzheimer’s Disease. Additionally, this individual will contribute to the organization by analyzing and communicating results for these studies and by providing input into clinical development strategies as well as by performing medical monitoring for these and, possibly, other studies within the Neuroscience Business Group. PhD required with 4+ years in clinical research in the pharmaceutical industry, preferably with experience in Neuroscience and especially Dementia (e.g., Alzheimer’s disease).
Marketing/Business Development/Alliance Management/Pricing
NEW – Business Development – Ecosystems, Manager – #2174 – Northern NJ – The Manager of Business Development, Ecosystems position supports the identification of opportunities and the execution of in-licensing transactions and the establishment of collaborations to facilitate the achievement of the organization’s Human Healthcare (hhc) mission, current and future objectives, and financial targets. Must have prior work experience in business development, corporate strategy, strategic consulting and/or investment banking with 2 years of relevant work experience. MBA or PhD preferred.
NEW – Contracting, Director – #2173 – Northern NJ – The Director of Contracting collaborates with HEOR to help identify innovative contracting options to bring value to payers, as well as across the whole organization such as Brand Teams, Managed Markets, Finance, Market Research, Legal, and other functional teams. Advanced degree preferred, 10+ years of US pricing and contracting experience.
NEW – Pricing Strategy, Director – #2172 – Northern NJ – In the current political climate with evolving state and federal price transparency laws, the Director of Pricing will lead all analysis regarding implication to the Company’s in-line and pipeline brands and pricing strategy, as well as work collaboratively with Legal and compliance to ensure timely and compliant submission of price reporting requirements. Advanced degree preferred, 10+ years of relevant experience in pricing and/or pharmaceutical contracting.
NEW – Marketing Director, Surgical Marketing – #2149 – St. Louis, MO – The Director of Surgical Marketing is team leader for our client’s cataract equipment and associated accessories, & consumable product lines and responsible for U.S. marketing. This includes: developing the U.S. marketing plans, planning the product portfolio, acting as key strategic interface to R&D and Clinical Affairs in new product development, conducting market research, developing and executing the product(s)’ brand positioning, messaging, and launching new products, product management and sales support, coordinating product life cycle management, and day to day business leadership and support. Must have Med Device /Health Care Capital Equipment Marketing Experience
NEW – Sr. Product Manager, Ophthalmic Devices & Software – #2148 – St. Louis, MO – Support a team launching a new first-to-market cloud based technology within the surgical environment. This role is responsible for developing marketing programs and tools that drive adoption and utilization of a novel phacoemulsification technology. This individual will establish strong relationships with external Key Opinion Leaders (KOLs), as well as internal stakeholders such as R&D, Manufacturing, Sales, Training, Legal, Regulatory, and Medical Affairs. Should know Medical Devices and, preferably, software/cloud based technology savvy.
NEW – Marketing Director, Surgical Marketing Ophthalmic Implants – #2147 – St. Louis, MO – This is a high visibility, high growth potential role. The Director of Surgical Marketing is team leader for the client company’s intraocular lens product lines and responsible for U.S. marketing. This includes: developing the global and U.S. marketing plans, planning the product portfolio, acting as key strategic interface to R&D and Clinical Affairs, coordinating product life cycle management, conducting market research, sales support, developing and executing the product(s)’ brand positioning, messaging, promotional and pricing platforms
NEW - Pricing & Analytics, Associate Director – #2146 – Northern NJ – The Associate Director, Pricing & Analytics will be responsible for developing and maintaining all customer pricing data in order to help Commercial executive management grow sales and market share. In conjunction with the EVP, Commercial and VP Sales, this role is responsible for day to day activities within the pricing function including ROFR’s, RFP’s, new product launches, and other bid proposals.
NEW – Marketing Director – Market Access, Hospitals/IDNs – #2142 – Northern NJ – The Marketing Director develops strategies and marketing materials to support the Regional Account Managers working in the field, developing and disseminating the Market Access Value Platform. Bachelor’s degree required, MBA preferred. Must have IDN, Hospital Marketing experience. Anti infective TA experience is a plus.
Business Development – Neurology Business Group, Senior Manager – #2131 – Northern NJ – This position supports the corporate growth objectives of the global Neurology Business Group organization and supports the identification of opportunities and the execution of in-licensing and out-licensing transactions to facilitate the achievement of the organization’s Human Healthcare (hhc) mission, current and future objectives, and financial targets. Must have prior work experience in business development, corporate strategy, strategic consulting and/or investment banking. MBA or PhD preferred.
NEW – Pharmaceutical Sales, Vice President of Sales – #2177 – Northern NJ – This role is responsible for providing management, mentoring and motivation of the field based pharmaceutical and media agency sales team to support generating new business, maintaining and growing current and new accounts, and fostering key decision maker relationships, for the purpose of driving advertising sales of digital and print programs with pharmaceutical brand teams and media agencies. 15+ years pharma sales leadership experience.
NEW – Sales Director – #2182 – Raleigh, NC – This role is responsible responsible for generating new business, maintaining and growing current and new accounts, and driving advertising sales of digital and print programs. 15+ years experience selling into pharmaceutical brand teams and/or pharmaceutical brand media agencies.
NEW – Sales Director – #2181 – San Francisco Bay Area, CA – This role is responsible responsible for generating new business, maintaining and growing current and new accounts, and driving advertising sales of digital and print programs. 15+ years experience selling into pharmaceutical brand teams and/or pharmaceutical brand media agencies.
NEW – Sales Director – #2180 – Chicago, IL – This role is responsible responsible for generating new business, maintaining and growing current and new accounts, and driving advertising sales of digital and print programs. 15+ years experience selling into pharmaceutical brand teams and/or pharmaceutical brand media agencies.
NEW – Sales Director – #2179 – Boston, MA – This role is responsible responsible for generating new business, maintaining and growing current and new accounts, and driving advertising sales of digital and print programs. 15+ years experience selling into pharmaceutical brand teams and/or pharmaceutical brand media agencies.
NEW – Sales Director – #2178 – Los Angeles, CA – This role is responsible responsible for generating new business, maintaining and growing current and new accounts, and driving advertising sales of digital and print programs. 10+ years experience selling into pharmaceutical brand teams and/or pharmaceutical brand media agencies.
NEW – Principal Medical Writer – #2157 – Westchester, NY – The Principal Medical Writer will be responsible for liaising with the appropriate matrixed team members to shape and review content of documents, and to follow up with other functional groups for materials needed for document completion, reviewing documents related to the CSR, such as the Statistical Analysis Plan and draft tables, figures and listings, and ensuring that they provide the appropriate information/data for a CSR, tracking all documents in a therapeutic area, overseeing more junior writers working on documents in their therapeutic area, and leading the Medical Writing effort in a clinical filing. Bachelor’s degree required with 8-10 years relevant industry experience.
Medical Writing – Neuroscience, Senior Manager – #2093 – Northern NJ – The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Neuroscience Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds’ life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Bachelor’s degree required; minimum 5 years of CNS medical writing experience with compounds targeted for epilepsy preferred.
Medical Writing – Oncology, Associate Director – #2090 – Northern NJ – The ideal candidate will be the designated Lead Medical Writer for one or more oncology programs, responsible for supporting the critical regulatory medical writing needs, and offering direction to other staff/contractors regarding these projects. As the lead writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management. Due to the complexity of the programs, the incumbent must rapidly acquire complete and advanced knowledge of the compound to ensure alignment and consistency across studies. The qualified candidate will have proven ability to write and effectively manage the document preparation when necessary. Bachelor’s degree in life sciences required.
Training & Development
NEW – Sales Training – Oncology, Manager – #2156 – Northern NJ – This position serves as the lead point-person and training subject matter expert with their respective commercial brand team(s) and coordinates brand/customer training strategies and needs. Serves as training liaison for training and sales with the assigned secondary customer and is responsible for managing training communications between the secondary customer, sales training teams, and the field sales forces.
NEW – Commercial Training & Development – Market Access & Account Management, Sr. Manager – #2155 – Northern NJ – Effective execution in this role will have a measurable impact on the organization by enhancing the account management capabilities of the company’s commercial teams within the market access and account management functions for both the neurology and oncology business groups. This position will act as a subject matter expert in the development of any market access and account management training programs.