Ruderfer & Associates
Biopharmaceutical Search Consultants

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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

Updated 12/07/2018

Regulatory Affairs/ Quality Assurance

  • NEW – Regulatory Affairs, Senior Director/Executive Director#2102 – Westchester, NY – This management position in Regulatory Affairs involves the ability to lead and manage the regulatory affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments/requirements. In addition, the position assists corporate senior management in understanding Regulatory strategies/processes while developing corporate objectives and, importantly, understanding the impact of decisions across therapeutic areas. Requires advanced degree in science related discipline; minimum 15 years of pharma experience.

  • NEWGlobal Clinical Quality Assurance, Sr. Director/Director – #2100 – Central, NJ – Under the guidance of the VP Quality, the Senior Director/Director of Global Clinical Quality Assurance (GCQA) will develop, implement and maintain the clinical Quality Assurance program to support global and local drug development, registration and marketing activities.  This position will work in partnership with Clinical Development, Regulatory Affairs, Pharmacovigilance and other business units to ensure compliance with Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GVP).

  • NEW Quality Assurance & Regulatory Affairs Operations, Director – #2088 – Northern NJ/Virtual – This position provides quality oversight and a single and consistent quality approach for our Development and Commercial products globally throughout the product development and commercial lifecycle. The QP acquires and applies product-quality knowledge and acts as the quality expert for assigned products throughout the product lifecycle This individual will be responsible for the maintenance and advisement of Quality Assurance & Regulatory Affairs as it relates to Quality Systems and the associated ISO 13485 standards and certification.

  • NEW Regulatory Affairs, Executive Director - Cardiovascular – #2085 – NJ or 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 company’s clinical asset candidates. 

  • NEW Global Regulatory Labeling, Director – #2084 – Northern CA – The Director of REG-GL provides regulatory labeling leadership to the labeling team and cross functional teams where Reg labeling membership is required. Manage the strategic regulatory labeling health authority interactions labeling negotiations worldwide. The Director is responsible for ensuring the execution of global regulatory labeling are aligned with the global regulatory strategy and corporate goals. Oversees and mentors labeling professionals to achieve regulatory objectives. A minimum of 12 years of pharmaceutical or health authority industry experience and at least 4-6 years experience in global labeling required. 

  • NEW 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.

  • NEW Regulatory Affairs, Director/Associate Director – CMC EU - #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.

  • NEW Regulatory Affairs, Senior Manager/Associate Director – Biologic CMC – #2076 – Northern NJ; Raleigh NC; or Philadelphia, PA – The Senior Manager/Associate Director, CMC Regulatory Affairs provides regulatory expertise on specific projects/queries relating to CMC for biologic products (primarily monoclonal antibodies (mAbs) in development from a global perspective and strengthen the science and scientific arguments made in the Quality section of all submissions (IMPDs/INDs, briefing documents for scientific advice, BLAs/MAAs, variations etc.) made by the company. Must have: Bachelor’s degree in science or technical discipline (advanced degree MSc., PhD, or MBA preferred); 4-6 years of relevant pharmaceutical experience plus 2-3 years of CMC biologic support for Sr. Manager / 6-8 years of relevant pharmaceutical experience plus 4-6 years of CMC biologic support for Associate Director.

  • NEW Regulatory Affairs Labeling Strategist, Manager or Senior Associate – #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.

  • NEW Clinical Quality Control , Director #2068 – Northern, NJ – New position, lead all Oncology Business Unit Quality Management for all Clinical processes (operations) in US and Europe including Clinical SOPs, Systems, data integrity, etc. Reports to a Corporate Officer and will lead a small team. Oncology experience is strongly preferred.

  • NEW Project Leader, Regulatory Affairs – # 2066 – Remote/NJ – The Project Lead, Regulatory Affairs is responsible for leading and executing all regulatory strategy and filings. In addition, this position will also provide regulatory support and guidance to cross-functional teams and ensure all applicable global regulatory requirements are considered and appropriately incorporated into clinical and commercial products. Must have: BS in Life Sciences or Chemistry; 7+ years of pharmaceutical experience with 5+ years of hands-on regulatory affairs project lead experience.

  • NEW – Quality Affairs, Manager – #2065– Fort Worth, TX - Develops and coordinates the execution of “customer-centric” quality and regulatory programs, prior QA experience required. Sterile products/medical device Quality/Regulatory experience strongly preferred.

  • NEWQuality Affairs, 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.

  • NEWDirector of Advertising & Promotion – #2060 – Westchester, NY - Review, approve and monitor product advertising and promotional labeling pieces for compliance with regulatory agencies’ requirements. Provide regulatory guidance regarding advertising and promotional materials, new campaigns and launch strategies for assigned products. Must haveBachelor’s degree in science or health related discipline (advanced degree PhD, MD, MS, or PharmD preferred); 8+ years of relevant pharmaceutical experience with 4-6+ years of relevant pharmaceutical advertising and promotion experience; knowledge of the pharmaceutical industry regulatory affairs discipline for prescription drugs. 

  • NEWAssociate Director, Quality & Compliance PV – #2062 – Westchester, NY – This position is responsible for managing staff and activities related to ICSR case quality reviews, ongoing monitoring of departmental compliance, and trending of quality and compliance metric to identify process improvements and advise the head of PV. This role will also provide support to department's effort in maintaining preparedness audits and health authority inspections. This is a supervisory role with individual contributor responsibilities.Maintain an accurate and timely system for monitoring / managing compliance with all case reporting requirements (eg, with health authorities, license partners, contract research organizations). Must have: Experience in a pharmaceutical industry with at least 2 years of people management experience and 10 years of industry experience----Minimum of Bachelors Degree Required. 

  • Director, Regulatory Affairs, Oncology – #2051 – Northern NJ – This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe.

  • Director, Regulatory Affairs, Oncology – #2049 – Northern NJ – Provide Regulatory strategic and tactical leadership for the Oncology business, interfacing with both internal and external stake-holders working on “breakthrough designations”. Involved in the entire product life cycle - pre-clinical to post approval. Requires Regulatory experience (4+ years). Must have team leadership experiences interacting with FDA. Oncology experience is strongly preferred.

  • Senior Director of Regulatory Affairs, Neurosciences – #2031 – NJ or 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.

  • Director of Labeling – #2020 – Southern 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.

  • Executive Director of Regulatory Affairs Immunology &  Inflammation – #2030 – 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 company’s clinical asset candidates.

  • Regulatory Affairs Advertising & Promotions Associate Director – #2013 – Central NJ – The Associate Director of Advertising & Promotion reviews, approves and monitors product advertising and promotional labeling pieces for compliance with regulatory agencies requirements. 

  • Director, Regulatory Strategy Oncology – #1905 - Central NJ  - This position independently leads the preparation, alignment and formulation of a global regulatory submission strategy with direct accountability for US and/or Europe. The role acts as point of contact for interactions with Health Authorities (HA) and global cross-functional team members and may lead team(s) when conducting FDA and/or EMA interactions. They will provide regulatory advice on internal or partnered development assets. Additionally, this position interacts with RA team members both regionally and globally, cross-functional team members, FDA Project Managers and/or Reviewers, and may interact directly or indirectly with ex-US Health Authorities.

Medical Affairs /Medical /Clinical Research, R&D, Project Management

  • NEW – Senior/Executive Medical Director, Clinical Research (Sleep)#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.

  • NEW – Senior Director, Clinical Research – Oncology#2105 – Northern, NJ – The Senior Director, Clinical Research - Oncology will be a key senior position in the Clinical Development group. The position carries operational and strategic level responsibilities for providing the clinical development, scientific and medical input, oversight and leadership for the company’s Oncology clinical development programs, with a focus on Early stage clinical development. Strategic accountabilities may include program leadership at IPT level, IPT lead role, design and execution of clinical development plans for oncology products from preclinical research. MD Required, Oncology Board Certified or Board Eligible, US or equivalent non-US preferred.

  • NEW – Senior Director, Clinical Research – Oncology#2104 – Northern, NJ – The Sr. Director, Clinical Research - Oncology is responsible for providing the medical input and medical oversight for early or late stage Oncology clinical development programs. The incumbent will successfully lead clinical trials Phase I - III, develop and author the necessary documents (e.g. NDA/CTA submissions, study protocols, Investigator Brochures, regulatory briefing books and regulatory response documents, clinical study reports, etc.) and provide expert clinical oncology input and review of the study data as well as lead publication of documents required. MD required. Board Certified or Eligibility in Oncology is preferred; will consider Oncology Clinical Development experience in lieu of Board Certification.

  • NEW – Associate Director, Clinical Research – Neuroscience#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).

  • NEW – Coding & Clinical Data Review, Senior Manager#2101 – Northern, NJ – Under the guidance of the Head of Clinical Safety Data Review – Oncology Business Group, the Sr. Manager, Coding & Clinical Data Review will manage and review serious adverse events from clinical databases to ensure completeness of patient data; review & provide guidance to data management and medical data specialists in reconciliation of adverse events between clinical and pharmacovigilance databases; guide medical data specialists in performing aggregate review of adverse events of special interest and assess discrepancies of study medication and adverse events action taken. The role requires the ability to write narratives or case descriptions as required by regulatory agencies. Master degree in medical or sciences field is required. Minimum 7 years’ experience in Data review; at least 2 years’ experience in Coding.

  • NEW Clinical Trial Disclosure & Transparency, Associate Director/Director – #2098 – Westchester, NY – Responsible for leading and managing global Clinical Trial Disclosure and Data Transparency activities for a leading biopharmaceutical company in Southern New York. Must have a minimum of 8 years in biotech/pharma industry. Experience in Clinical Science, Clinical Operations, or Medical Writing preferred.

  • NEW –Pharmacovigilance Operations, Director/Sr. Director #2095 – NYC – This position handles operations side for a publicly listed biotech company in NYC.

  • NEW – Epidemiology – Cardiovascular, Director #2092 – Southern NY – The Director of Cardiovascular Epidemiology will assume the lead role in epidemiology activities in support of marketed and development compounds of cardiovascular therapeutic area (TA). You will be accountable for pharmacoepidemiology strategy, leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, and providing consultation as an in-house subject matter expert in epidemiology to other departments. MD degree in epidemiology required; 8+ years of experience including 5 years of industry/regulatory experience.

  • NEW – Epidemiology, Director #2091– NY or NJ – The Director will be accountable for epidemiology strategy and pharmacoepi projects for assigned marketed and/or development compounds as the therapeutic lead, leading epidemiology activities and cross-functional project teams to support clinical development and regulatory required non-interventional studies, and providing consultation as an in-house subject matter expert in epidemiology to other departments. Must have MD degree in epidemiology; 5+ years of post-doctoral experience, including 3 years of industry/regulatory experience.

  • NEW – Clinical Research - Oncology, Associate Director #2087 – 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. Must have a PhD or MD level degree; minimum 5 years of clinical research experience in pharmaceutical industry.

  • NEW – Senior Director Pharmacovigilance Operations #2086 – Central NJ – This position oversees case processing activities, staffing, processes, and interdepartmental projects involving PV case processing. This position collaborates within CSPV, global teams, sites and interdepartmental teams and interacts with CROs, vendors, and partners.

  • NEW – Clinical Development, Medical Director – #2074 – Northern NJ – The Medical Director will be responsible for providing medical and scientific direction and support to specific company clinical programs in line with its core business. This position will interact with competent authorities including the FDA, and lead filings for new drugs and/or indications from a medical perspective in collaboration with other functions - including Regulatory Affairs. The Medical Director may assume the role of Clinical Development Lead and/or Medical Monitor for a compound.

  • NEW – Executive Director Pharmacovigilance #2073 – 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.   

  • NEW – US Lead, Executive Director, Medical Affairs – Alzheimer’s Disease – #2070 – Northern NJ – US Medical Lead for all Alzheimer’s Disease Medical Affairs' strategic and tactical efforts including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan as well as strategic development, planning, implementation and oversight of Phase IV clinical trial programs. MD degree required along with Alzheimer’s TA and pharmaceutical Medical Affairs experiences.

  • NEW – Risk Management, Director – #2063 – 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 MD degree 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).

  • Medical Affairs, Executive Director, US Medical Lead – Sleep Disorders – #2058 – Northern, NJ – Develop and execute the medical affairs plan, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of the overall medical operating plan. The incumbent will provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area.  Must be Board Certified in Neurology, ideally with subspecialty in Sleep Medicine and US fellowship training and MD with 12+ years’ experience within the pharmaceutical industry including 10 years in-house Medical Affairs role.

  • Executive Director, Clinical Research – Alzheimer’s #2015 Northern, NJ - The Executive Director, Clinical Research will provide direct support as a Subject Matter Expert to various compounds & programs related to the Alzheimer's Disease therapeutic area. Dependent upon specific projects or compounds, the incumbent may function as a International Project Team Leader. It is essential that qualified individuals possess Medical Doctor credentials.

  • Sr. Medical Director, Global Medical Affairs Epilepsy – #2012 – Northern NJ  – The Sr. Medical Director, Global Medical Affairs - Epilepsy will be responsible for working with key stakeholders to develop and execute the medical affairs plans for pipeline assets and marketed Epilepsy Products, including post-marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plans.

Marketing/Business Development/Alliance Management

  • NEW – Director Marketing, PRC – # 2097 – Central NJ – Lead Promotional Review Committee support services team in compliance with the Advertising and Promotion Standard Operating Procedures; establish collaborative relationships with Marketing Operations Group; manage the technology and operations to support commercial demand, anticipating needs, communicating to all levels of the organization, and influencing without authority. 10 to 15 years pharma sales and marketing management required.

  • NEWDirector/Senior Director, Marketing, GI – #2081 – Central NJ – Well known, global pharma company and leader in this and other Therapeutic Areas, seeks entrepreneurial, Branded, Rx-Products Marketer to join its GI Marketing teams a Marketing Director. Responsibilities will cover all facets of the marketing continuum from established brands to new products. Experience required in all of these areas: Able to speak to both KOLs and HCPs in general; strong understanding of the trade, marketing communications and digital; market access; pricing; and forecasting. Small or mid size pharma company experience is a plus. Opening is due to internal promotion. Reports to a dynamic leader. Competitive compensation package and potential for growth.

  • NEWManger Innovation/Product Development Marketing – #2079 – Chicago Metro – The Manager, Innovation/Product Development to assist in identifying opportunities for innovation and new products opportunities. Recommend and implement programs that address these opportunities. Manage the new product development mix (product, pricing, placement and promotion) for mechanical and chemical product opportunities. Bachelor’s degree required; 3 to 5 years of CPG marketing/innovation experience. Must be knowledgeable in market research techniques related to new product development. Oral care/dental categories knowledge highly preferred. 

  • NEWDirector Strategic Accounts – #2069 – Virtual – The ability to work in a team-oriented environment is essential in order to position highly strategic sales to our manufacturer and agency clients. Presentation and communication skills are essential to be successful in this role. Must have a minimum of 8 to 10 years advertising sales experience in pharmaceuticals.

  • NEWDirector, Business Development – #2067 – Central NJ – Lead all BD efforts for a Generic company focused on new compounds and 505B2 products.  Must have prior generic experience including in and out licensing, M&A, and work with Investment Banking community.

Medical Writing

  • NEWMedical Writing, Associate Director/Director – #2094 – Northern NJ – The role of the Associate Director Medical Writing is to ensure all clinical study and submission documents for assigned projects are prepared, reviewed, and approved in a quality, timely and accurate manner such that the data presented will be appropriate for review by the agencies.  The role is responsible for leading medical writing activities to support US, European and other regulatory submissions.  The Associate Director Medical Writing will be accountable for ensuring that deliverables are prepared according to appropriately rigorous and objective medical writing and quality management procedures and processes.

  • NEWSenior Manager, Medical Writing - Neuroscience – #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.

  • NEWAssociate Director, Medical Writing - Oncology – #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.  

 

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