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
Regulatory Affairs/ Quality Assurance
- NEW – Risk Evaluation and Management Strategy, Director– #1989 – Northern NJ - The Director, REMS is responsible for leading and managing all REMS related activities in the US. They will Collaborate with regulatory affairs department in India in planning, implementation and execution of activities related to the REMS program, and maintain databases (or coordinate with REMS administrator) for all training related details of the physicians, pharmacies and distributors who are certified and for patients when enrolled in a registry.
- NEW – Global Regulatory Affairs Oncology Senior Manager – #1984 – Northern NJ - This Sr. Manager, Regulatory affairs will develop and implement regulatory strategies to facilitate optimum global approval of new medicinal products. This position contributes to the planning, execution and assessment of product life cycle management activities and strategies. In addition, this person contributes to the clinical development plans, global regulatory strategic plans, and provides advice on US regulatory clinical trial and marketing authorization requirements to the International Project Teams (IPTs) or Regulatory Sub-team.
- NEW- GCP Quality Director Inspection Management- #1980 – New York - This position reports to the Senior Director/Head, GCP Quality, Global Development (GD) This will be a hands-on position that will be responsible for planning, preparing and conducting GCP/GPV inspections by regulatory authorities (e.g. FDA, EMA, PMDA). This will include, but not limited to, inspection readiness activities (e.g. start-up and gap assessments), inspection management training, developing and maintaining the Company’s inspection management process and development of inspection management tools and systems. The expectation is that GD will remain inspection ready at all times.
- NEW- Director/Senior Director Regulatory Affairs- #1962 - NYC or MA - The person will be responsible for leading the development and execution of global regulatory strategies for innovative medicines that address unmet medical needs and bring significant value to patients in diverse therapeutic areas.
- NEW Director/Associate Director Regulatory Affairs Medical Device # 1961 - NYC, MA or NC - The individual will be responsible for informing regulatory policies and leading the development and execution of global regulatory strategies for medical devices or assigned drug-device combination development programs.
- Director Global Regulatory Lead, Consumer - #1948 - Northern NJ -The Director, Global Regulatory Lead Consumer will provide strategic regulatory expertise as Global regulatory representative to Product/Project Team(s). They will lead and coordinate a virtual Global Regulatory Strategy Team (GRST), encompassing in country regulatory colleagues from North America, EMEA, APAC &; LATAM as appropriate. Through the GRST, they will develop, align, manage and implement the global regulatory strategy and risk assessment including determination of regulatory probability of success and risk mitigations.
- Senior Project Manager, Medical Devices Regulatory Affairs - #1935 - Northern NJ - Prepare worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory issues with supervisor, as necessary, and negotiate submission issues with regulatory bodies. Prepare regulatory strategies/plans and worldwide compliance requirements.
- Project Manager, Regulatory Affairs Submissions - #1934 - Northern NJ - Prepare worldwide submissions for new products and product changes as required to ensure timely approval for clinical studies and market release. Review significant regulatory issues with supervisor, as necessary, and negotiate submission issues with regulatory bodies. Prepare regulatory strategies/plans and worldwide compliance requirements.
- Director, Regulatory Strategy - #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.
- Associate Director – Regulatory Operations – #1846 – Central NJ – Responsible for the electronic assembly, routine planning, publishing, production, dispatch, and archive of regulatory submissions and supports a specific subset of a discipline within a function. This position ensures SOP adherence, application of best practices, oversight of CRO, and customer interactions. The position works in ambiguity with complex problems and defines directions with limited direct supervisor oversight. Additionally, this position demonstrates expert Regulatory publishing skills, a general proficiency in Process Excellence and planning, and expert working knowledge of electronic document management practices and related technologies.
- Manager - Regulatory Affairs – #1841 – North Carolina or NYC – Responsible for contributing to the execution of successful regulatory strategies for innovative medicines that meet company objectives, differentiate from competitors to bring added value to patients, and enable optimal market positioning and commercial success in key markets around the world. Accountabilities include organization and maintenance of existing regulatory documents, preparation of documentation for INDs and CTAs for regulatory agencies; review and evaluation of reports and submissions; and coordinate preparation of amendments, supplements and annual reports for development programs.
Medical Affairs /Medical /Clinical Research, R&D, Project Management
- NEW – Medical Lead – #1992 – NJ/PA The Medical Lead of Clinical Development is responsible for clinical study strategy, design, and conduct for all phase clinical programs across therapeutic areas that the Company focuses on. He/she communicates the clinical findings/results through medical communications (e.g., presentations, publications, etc.) and interfaces with key opinion leaders in the field. He/she is responsible for overall clinical study timelines and key deliverables. He/she acts as resources to internal and external customers on medical related issues.
- NEW – Clinical Data Manager Lead – #1991 – NJ/PA - The Clinical Data Manager Lead is responsible for all aspects of the data management process from the development of project documentation, system set-up, UAT through database lock. The core duties and responsibilities are delineated below.
- , educational programs and other tactics associated with the array of Alzheimer's Disease compounds in our portfolio.
- NEW – Clinical Research, Associate Director Oncology – #1985 - Northern NJ The Associate Director, Clinical Research Scientist will assist the Clinical Lead and/or Study Director in the planning, preparation, implementation, execution, day to day managing and reporting of clinical trials. Candidates must be a PhD or MD with 5 years of experience in clinical research in the pharmaceutical industry and a thorough understanding of clinical research methodology including study design, protocol writing and CRF preparation.
- NEW- Senior Clinical Study Leader (Non Interventional/Observational) - #1982 – New York - The Senior Clinical Study Leader (CSL) is accountable for the global execution of assigned large and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and ensuring study conduct is in accordance with the Company’s Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies out-sourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives. Responsible for direct line management responsibilities.
- NEW – Vice President, Biologics Discovery – #1981 – Northern NJ/China – Lead the global strategy and capability delivery of the biologics discovery team. Provide scientific leadership with hands-on, “end-to-end” expertise and guidance throughout the preclinical phase, including development enhancement. Harnessing internal expertise along with external innovations to develop a pipeline of novel and differentiated biologic drug candidates.
- NEW – Sr. Clinical Research Scientist/Associate Director Oncology – #1979 – Northern NJ – The Senior Clinical Research Scientist/Associate Director will participate in global Oncology Research Studies. The primary responsibility will be to support protocol development and all amendments, study conduct, review study documents, and support the presentation of the data thereby, increasing the efficacy of the study directors and team leaders.
- NEW – Medical Director or Senior Director, Medical Affairs, Alzheimer’s/Epilepsy – #1973 – Northern NJ – The Medical Director, Medical Affairs is 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 plans. Primary areas of focus will include Alzheimer’s Disease and Metabolics. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area.
- NEW – Medical Director or Senior Director, Medical Affairs, Neurology/Epilepsy – #1972 – Northern NJ – The Medical Director, Medical Affairs is 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 plans. Primary areas of focus will include Epilepsy, Sleep Medicine,. Provide strategic development, planning, implementation and oversight of Phase IV clinical trial programs within the Medical Affairs department for products in the therapeutic area.
- NEW – Director – Drug Safety – #1971 – Central NJ – This position leads SMTs and is a recognized product safety expert for assigned Phase 1 and 2a products.
- NEW- Clinical Director, Oncology - #1960 - Northern NJ - TWO POSITIONS. The Clinical Director will lead Clinical Development for all phases of Clinical Development with a particular focus on Phases II- III. Prior solid tumor, clinical leadership
- Medical Director, Oncology - #1949 - Northern NJ - Provide Medical Leadership for Medical Affairs strategy, planning, and supportive tactics. Responsible for working with stakeholders to develop and execute medical affairs plans, including post marketing research, medical education, research grants, medical advisory boards, and scientific communication/publication components of overall medical operating plan. The Medical Director provides strategic development, planning, implementation and oversight of Phase IV Oncology clinical trial programs and strategic input for product strategies and will interact with external stakeholders to solicit feedback and strengthen the Company’s medical reputation in Oncology. This position encompasses approval of medical and scientific content of all relevant materials/communications. MD degree required, Board Certification strongly preferred.
- Biostatistics, Senior Manager to Director – #1917 – North Carolina– The Senior Manager to Director, Biostatistics will have responsibility and accountability of Biostatistics across the company portfolio, including development and regulatory submissions. This individual will engage clinical and project teams across the company’s portfolio, providing subject matter expertise and strategic direction to the Clinical programs. He/She will partner with non-clinical and clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation. He/She is expected to provide oversight and supervision of relevant external consultants and clinical research organizations, primarily as it relates to external statistical and programming work. Experience with clinical pharmacology studies, design and analysis, would be beneficial.
- Senior Clinical Project Manager – #1907 – Northern NJ– The Senior Clinical Project Manager, Oncology will manage phase 1-3 clinical trials with specific focus on the technical (medical/scientific) input and operational coordination of clinical studies, with external experts, service providers, internal department and project teams. .
- Associate Medical Director – #1794 – Greater Philadelphia Area – Ensures the clinical and medical relevance of projects and activities of assigned accounts within the agency. The role requires deep understanding of our clients’ products (mechanisms, clinical data, competitive differentiators), the conditions they treat (disease mechanisms, epidemiology, standards of care), and relevant prescriber details (practice behaviors, prescribing decisions and trends). Responsible for medical strategy input in the overall planning of accounts, scientific excellence of content developed within the agency, and education/training of agency staff. Interact internally with client service, strategic planning, and creative staff, and with clients as required. Train junior agency staff on product mechanisms, interact with client Medical Affairs on relevance of clinical data, and interview external clinical investigators.
- Director, Safety Assessment – #1791 – NYC or North Carolina – The Safety Assessment Director will be responsible for managing the nonclinical safety assessment program of potential compounds in various stages of development. Responsibilities include generating safety assessment development plans for compounds in the portfolio; authoring risk assessment documents for clinical programs and regulatory submissions (INDs, CTAs, IBs, DSURs, etc); conducting due diligences and gap analyses on compounds of interest; reviewing CRO toxicology study reports to generate quality reports for regulatory submissions; and effectively communicating toxicology findings to project teams, senior management, and regulators (FDA) as needed.
- Sr. Manager, Safety Assessment – #1790 – NYC or North Carolina – The Senior Manager of Safety Assessment will support the safety assessment of potential compounds in various stages of development. Responsibilities include contributing to regulatory submissions (INDs, SPAs, IBs, etc); liaising with CROs to request bids/proposals to conduct nonclinical toxicology studies; managing generation of work orders/POs/invoices for contracted studies; qualifying CROs and monitoring pivotal studies; managing/tracking timelines of studies; reviewing and interpreting data and revising, as necessary, CRO toxicology study protocols/reports to generate quality reports for regulatory submissions.
- Manager, Safety Assessment – #1789 – NYC or North Carolina – The Manager of Safety Assessment will have the opportunity to learn drug development by working with an experienced team. Responsibilities include liaising with contract research organizations (CROs) to request bids/proposals to conduct nonclinical toxicology studies; managing generation of work orders/POs/invoices for contracted studies; qualifying CROs and monitoring pivotal studies; managing/tracking timelines of studies; reviewing and interpreting data and revising, as necessary, CRO toxicology study protocols/reports to generate quality reports for regulatory submissions.
Medical Advertising/Medical Education/ Communication Agencies (eMarketing)
- NEW- Account Supervisor/Account Manager - #1977 – Northern NJ - Medical Communications/Strategy Agency focused on Market Access issues seeks AS, AE or Manager with experience in the Medical Adversiting area. Experience with Market Access strategies and tactics strongly preferred.
- CME Distribution Sales Associate – #1714 – NY Metro Area – This position is responsible for sales to medical educational and communication (MEC) firms. Candidate will identify and pursue new business opportunities as well as retain and grow existing business. Should have knowledge and understanding of the trends in medical education industry. Minimum 5 years experience working with (business-to-business) medical education and communications (MEC) firms required.
- Sr. Director of Educational Development – #1713 – NY Metro Area and West Coast – This position is for a highly motivated self starter responsible for the growth and overall management of medical educational grants. The successful candidate will identify and pursue new business opportunities. Knowledge and understanding of the trends in grants, medical education with therapeutic area insights, and patient outcomes is essential. Understand program outcomes and metrics and ensure that they are used in assessment of grant opportunities. Demonstrates ability to review grants in different therapeutic area(s).
- Director Strategic Accts - Professional – #1572 – Virtual – Requires strong relationship building skills, knowledge of interactive media buying and selling. Knowledge of the Pharma space a plus. 5-10 years advertising sales experience required; 5+ years of Internet sales pref.
Marketing/Alliance Management - Branded & Generics
- NEW- Sr. Director, Information Management - #1994 – Northern NJ - The Sr. Director, Information Management will be responsible for developing an Information Management strategy to ensure the proper procurement, implementation, governance, and support of the data assets critical to the Commercial business.
- NEW- Director, Hospital Marketing - #1993 – North Carolina- The Director, Hospital Marketing reports to the Senior Director, Marketing and will be responsible for developing, implementing and managing strategic and tactical plans and launch operations for a hospital product.
- NEW- Manager or Senior Manager Business Development & Alliance Management - #1988 – Northern NJ - The Manager/Sr. Manager of Business Development and Alliance Management position supports the corporate growth objectives of the global Neurology Business Group organization. The position 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. The Manager/Sr. Manager position works extensively with multidisciplinary internal and external teams, establishes and manages relationships with existing and/or potential partners, creates and delivers presentations and reports to senior management and key decision makers and helps drive Business Development projects opportunities through the Company’s review and approval processes.
- NEW- Director, Consumer Product Ad/Promo and Labeling - #1987 – Northern NJ - The Director of advertising & promotion and labeling for consumer products manages and/or participates in the review and approval of advertising and promotional pieces and labeling for consumer products. This includes OTC drugs, nutritionals, cosmetics and devices. The Director is responsible for ensuring the pieces are in compliance with all applicable laws and regulations. The Director is also responsible for managing the personnel who lead the development of labeling for consumer products, including OTC drugs, nutritionals, cosmetics and Class I and II devices.
- NEW- Neurology Marketing Associate Director - #1975 – Northern NJ - The Associate Director, Marketing - Neurology - will lead and execute the overall strategic direction, design, execution and measurement of all HealthCare Professionals and Consumer-oriented marketing strategies, tactics and activities to deliver on the brand's objectives. Collaborate with the Managed Markets team on enabling access with key players and institutions.
- NEW- Pipeline Development (Generics) - #1964 – Northern NJ - The responsibilities of this position include developing and maintaining business relationships in the generic and mature brand market place for the purpose of identifying revenue generating pipeline development opportunities. The Senior Director of Pipeline Development will work with external companies to find opportunities to develop new products (ANDAs or NDAs) or work internally within the Company to do the same.
- Marketing Coordinator - #1950 - Northern NJ - Provide executive-level marketing and administrative support for the Marketing Center leadership team. This position reports directly to the VP Sales & Marketing
- Associate Director, Marketing – #1931– Northern NJ– The Associate Director, Marketing will oversee pricing & portfolio management to drive profitable growth while anticipating new market/competitive dynamics. They will collaborate with National Accounts and Senior Management in pricing strategy, and work closely with Senior Management, Supply Chain and National Accounts to flawlessly execute new product introductions. They must understand customer and market dynamics and trends in order to address customers’ unmet needs, and analyze the needs of the organization proactively to ensure that the marketing activities for supporting the current and future commercial activities are met.
- Director, Engineering – #1929 – Northern NJ – Responsible for the overall direction to the engineering function through the development of site engineering procedures consistent with organizational requirements and corporate standards.
- Life Sciences Strategy Consulting Director– #1945 – TBD (NY, MA, or CA) - The Life Sciences Strategy Consulting Director will identify and pursue business development opportunities, lead consulting engagements, and manage client relationships. In addtition, they will guide engagement teams to develop logical and insightful analyses, innovative and effective recommendations, and well structured, high-quality deliverables.
- Consultant/Senior Consultant, Life Sciences – #1946 – TBD (NY, MA, or CA) – Work closely within engagement teams and with clients to: lead primary and secondary research; develop logical and insightful qualitative and quantitative analyses; create innovative and effective recommendations; and develop well-structured, high-quality deliverables
- Life Sciences Engagement Manager– #1947 – TBD (NY, MA, or CA)– The Life Sciences Engagement Manager will guide engagement teams to develop: logical and insightful analyses; innovative and effective recommendations; and well-structured, high-quality deliverables in order to realize high levels of client satisfaction. They will play an active role in practice development and help identify, pursue, and secure business development opportunities.
- NEW- Sr. Director, Information Management - #1994 – Northern NJ - The Sr. Director, Information Management will be responsible for developing an Information Management strategy to ensure the proper procurement, implementation, governance, and support of the data assets critical to the Commercial business.
Market Access/Managed Care
- NEW- Director of Outcomes Research - #1974 – Northern NJ - The Director of Outcomes Research will serve the company as a subject matter expert for epidemiology and real world evidence (RWE) projects that support HEOR research, its planning and execution, as well as conducting and publishing studies. Additionally, the Epidemiologist will provide input to product and business development by applying his/her knowledge of epidemiologic study designs, methods, literature, and analyses to meet the needs of our team and customers.
- Health Outcomes/Market Access Director– #1936– Northern NJ– Global HEOR Director at well-funded startup. Will support Sr. Director, HEOR and various subsidiaries in HEOR efforts.
- Senior Director, Health Outcomes/Market Access – #1840 – North Carolina– Responsible for the design, implementation, management and delivery of health economic/outcomes research studies, or programs to maximize global market access and commercialization. Furthermore, the role includes working with external regulatory and health technology assessment (HTA) organizations to seek scientific advice on the strengths and weaknesses of evidence generation plans to maximize reimbursement potential. This individual will be responsible for closely collaborate with Clinical, Regulatory and Commercial teams to help shape and leverage clinical trials and ensure appropriate evidence generation in support of global market needs.
- NEW- Medical Writer- #1978 - Northern NJ - Market Access Agency seeks medical writers to support various clients, primarily in the Oncology space.
- NEW- Senior Medical Writer- #1967 – Northern NJ - The role of the Senior Medical Writer is to ensure that 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.
- Associate Director, Medical Writing - Neuroscience – #1891 – Northern NJ – Acts as the designated Lead Medical Writer for approximately 3 Neuroscience or General Medicine Programs, responsible for providing needed support and direction to other staff/contractors on these programs. 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 effectively manage the outsourcing of document preparation when necessary and the associated service providers.
- NEW- Associate Director/Director GCP Training - #1990 – New York State - The Associate Director/Director in Global Development’s Training department serves in a Business Partner role and is responsible for driving the strategy and implementation of training for assigned functions within their business areas. This includes working with stakeholders from Clinical and/or Regulatory disciplines to translate business needs into plans for the design and delivery of effective training assets in accordance with ICH/GCP requirements and current training design methodologies (e.g., ADDIE). They will also manage general stakeholder training and support needs and identify requirements by interviewing, diagnosing, assessing risks, and making recommendations that result in improved overall workforce enablement. In addition, they will work with external partners (CROs) to ensure compliance with clinical trials training requirements.
- NEW – Human Resources Business Partner – #1976– NYC, NC, or MA - Our client is seeking exceptional talent for its HR team. The HRBP will have experience assessing and anticipating HR needs while acting as an employee champion and change agent to develop integrated solutions. As a member of the HR team, you will align business objectives with employees and management in designated business units by serving as a consultant on HR related issues. Our client is a fast-growing company, with high demands and believes that this position will provide a unique opportunity to assist in building a respected local and international presence.
- NEW – Talent Acquistion Lead – #1965 – NYC - The Talent Acquisition Business Partner will have full cycle recruiting experience, to attract, screen, select and onboard world class talent to fill job openings. As a member of the HR/Talent Acquisition team, you will work with the HR department and departmental management to actively seek out exceptional candidates for continued development and growth at the Company.
- NEW – Director, Business Development – #1983– Northern NJ - The Director of Business Development, Biopharma-MDD position is primarily responsible for selling the Company’s digital and print healthcare solutions to Pharmaceutical, Biotech, and Life Sciences companies. Ideal candidates are top sales performers with demonstrated success in selling to companies within the target markets listed. The incumbent will be expected to meet and exceed assigned sales quotas for their respective accounts and actively pursue new accounts through his or her existing network. The position will require travel and the ideal candidate will work remote, from home office.
- Business Development – #1913 – Remote – Leading Managed Markets/Market Access Agency– Open doors with pharma and bio-tech companies’ Market Access/Managed Care/Marketing teams for this Agency’s range of services. Prior BD experience with pharma clients is required; Market Access and/or Oncology experience is required.
- Executive Assistant– #1944 – Northern NJ– Provide administrative and organizational support to the Executive Vice President & Head of North America Generics. You will be responsible for calendar management and travel management, as well as any special projects assigned. The company is looking for someone who is proactive, polished, able to prioritize, and has excellent communications skills (both written and oral). Confidentiality and discretion are required for this role.
Ruderfer & Associates, Inc.
Tel: (973) 239-2000