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- Manager, Regulatory Affairs - #1943 - Northern NJ - Oversee the process of preparing product submissions to domestic and international regulatory bodies and manage process from inception to approval. Establish and implement global regulatory strategies with cross-functional teams to assure compliance and approval. Lead a team in an effort to ensure compliance with regulatory requirements for products which will include marketing, labeling, and literature review.
- NEW- Senior Project Manager, 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.
- NEW- 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.
- Regulatory Affairs Labeling Director - #1924 - Central NJ - This position serves as the RA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product labeling in collaboration with Global Regulatory Leads (GRLs).
- Regulatory Affairs Lead, Senior Director - #1914 - Northern NJ - The Regulatory Affairs Lead will serve as the representative for a variety of innovative projects potentially in oncology, autoimmune diseases, and/or respiratory therapeutic areas. The Regulatory Affairs Lead will facilitate product development and global registration to achieve the desired labeling by developing and executing high quality regulatory strategies and effective FDA/health authority interactions. Heavy experience in the CMC arena is required. This position will guide development programs, anticipate changes in the regulatory environment and approval requirements. The individual will serve as a credible, influential, respected corporate spokesperson during interactions with regulators and regulatory agencies in the US and ex-US and will provide mentoring and leadership for team during interactions with health authorities.
- Regulatory Affairs CMC Biologics Director and Associate Director (2 Positions) - #1906 - Central NJ - This position serves as the Regulatory Affairs (RA) CMC expert project representative to the CMC sub team providing guidance on RA CMC regulatory and technical issues and serves as the RA CMC representative to the RA team.
- 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.
- Regulatory Affairs, Surgical Devices, Sr. Manager – #1886– Central NJ – (4 Openings) The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with FDA for their assigned surgical products and may perform due diligence efforts on new product opportunities.
- Vice President, Regulatory Affairs, Generics – #1874 –Philadelphia Suburb – The Head of Regulatory Affairs is a member of the Pharma Executive Committee and provides strategic and operational leadership for the global Regulatory Affairs function. He/she is responsible for developing and implementing effective global regulatory strategies that enable business growth priorities and ensure high standards in regulatory processes and quality compliance. The Vice President will also be responsible for establishing and developing relationships with international regulatory agencies for effective communication and collaboration on all issues affecting regulatory submissions and maintenance.
- Director/Associate Director Dossier Planning – #1873 – Central NJ – The role of the Director, Dossier Planning, Regulatory Operations will primarily be responsible for managing the planning and delivery of regulatory submissions (IND, NDA, Agency Responses, others) required to support the development and registration of new products for worldwide customers.
- 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.
- Manager, US Regulatory Affairs – #1837 – Northern NJ – Assist the Regulatory Affairs department in completing regulatory correspondence, assembling IND and NDA submissions, reviewing regulatory submissions, and working with the senior staff to develop regulatory strategy.
· Director Regulatory Affairs CMC – #1809 – NYC – Responsible for managing the CMC related regulatory affairs activities and provide CMC regulatory input to the CMC/Pharmaceuticals Development team and to the project teams. Maintain the change control process in order to keep all CMC sections of INDs /IMPDs/NDAs/MAAs current.Must have indepth CMC regulatory affairs experience and knowledge to provide timely guidance to the teams and to proactively prepare the anticipated responses by collaborating with the CMC pharmaceutical development team.
Medical Affairs /Medical /Clinical Research, R&D, Project Management
- Director or Associate Director, Modeling and Simulation- #1928 - Central NJ - The purpose of this position is to conduct population PK/PD analysis for pooled Phase 1 studies, perform trial simulation for Phase 2/3 studies, and write M&S reports. This position demonstrates significant knowledge of pooled Phase 1 studies, PK/PD and biomarker data, PK/PD analysis-ready data file derivation, complex disease modalities, regulatory guidelines pertaining to M&S, and programming and analytical software. This position works independently on complex studies/models and interacts effectively with project team members, CRO, and regulatory agencies.
- Director, Biostatistics Oncology - #1927 - Central NJ - The Director, Biostatistics Oncology leads very complex studies or entire drug project in study design, data analysis and interpretation of results independently with minimal supervision. This position provides input to entire drug development plans with minimal supervision and authors regulatory responses and other documents with minimal supervision. This position interacts with global project teams and global Health Authorities, as well as contract research organization (CRO) programmers and statisticians. Additionally, this position works under minimal supervision to solve complex project problems.
- Global Pharmacovigilance Head – #1926– NYC– The Head, Global Pharmacovigilance, will lead the pharmacovigilance and drug safety group and activities within the Company. This individual will be responsible for the strategy, design and further development of the pharmacovigilance and drug safety function, translating the development strategies into tactical plans to support product development and commercialization objectives in a rapidly growing, global organization.
- Clinical Pharmacology, Associate Director – #1923– Northern NJ– Expected to be clinical pharmacology lead on at least 3 projects and is expected to have such experience in previous job function in pharmaceutical industry. The candidate is expected to have the appropriate education (PhD or MD/PhD) and worked at least 3 years in a similar capacity in the pharmaceutical industry. The candidate is expected to be an active contributor to the multi-disciplinary project teams, providing innovative and progressive thinking to projects and where appropriate guidance to other team members.
- 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.
- Senior Statistician – #1900– Northern NJ– Provide experienced Statistical insight to Clinical Development Plans (CDP), Clinical Study Protocols (CSP) and Clinical Study Reports (CSR) across the Innovative and Approved products/Branded generic portfolio globally.
· Clinical Research Associate Director – #1893– NYC– This role assists project team with design and implementation of clinical studies with emphasis on the protocol/therapeutic area specific activities (e.g., data management deliverables, protocol level plans, operational feasibility, database updates, preparation of meeting materials, clinical supplies planning, communication plans, safety and medical monitoring, preparation of status update reports, study close-out activities). They will support scientific aspects of clinical trial(s) and program level activities as assigned. In addition, they will contribute to authoring of clinical sections of protocols, clinical study reports, regulatory agency update reports, and other clinical and regulatory documents with focus on more routine/standard document elements, and interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives.
· Clinical Pharmacology Director or Associate Director – #1884 – New York City– Responsible for providing medical support to Phase 1 studies across therapeutic areas for assets in all phases of clinical development. The employee will be an integral member of the project team and have responsibilities that include medical monitoring, safety reviews, study design, and protocol development. The position will involve writing and review of regulatory documents, protocols, and study reports. The employee will also assist in due diligence efforts for potential acquisition of new products and/or technologies. Opportunities for project leadership roles would also exist.
· Manager to Director, Clinical Pharmacology Operations – #1879 – North Carolina– This individual will work within a multi-disciplinary project team and have responsibilities for operational planning, implementation and conduct of Phase 1 and Phase 2a studies. The position requires the ability to oversee all aspects of clinical pharmacology study operations including protocol development, CRO oversight, budgets, timelines, contracts, study set-up, study conduct, and site assessment. The individual will lead programs with an independent approach requiring the ability to multi-task on a wide spectrum of activities.
· Executive Director Pharmacovigilance – #1877– Central NJ – Responsible for managing all of the PV operations activities associated with collecting, processing, and reporting spontaneous adverse drug reactions for the client’s marketed products and serious adverse events from clinical trials. This position also serves as a lead on global committees and task forces to ensure the alignment of safety processes across the affiliate sites are completed in compliance with global regulations.
· Senior Clinical Data Manager – #1875 – Northern NJ – Provide experienced clinical data management insight to Clinical Study Protocols (CSP), Clinical Report Forms (CRF) and development of clinical data bases across the Innovative and Approved products/Branded generic portfolio globally. The candidate should be able to “think with the end of mind” to ensure the compliance in terms of data collection and presentation to support regulatory dossier submission.
· Clinical Research – Neuroscience – Director – #1871 – Northern NJ – This position will design and oversee the conduct of clinical programs/studies for Phase II and III development of compounds targeting neurological disorders encompassing epilepsy and other studies. The Director will provide input into clinical development strategies for these indications and potentially, others. PhD required.
· Director or Senior Director, Biostatistics and Data Management – #1839 – North Carolina or NYC – Responsible for engaging clinical and project teams across the company’s portfolio, providing subject matter expertise and strategic direction to the Clinical programs. They will partner with non-clinical and clinical teams regarding the conduct of experiments, statistical methodology, data analysis and interpretation, and managing regulatory issues. They are expected to provide oversight and supervision of relevant external consultants and clinical research organizations, primarily as it relates to external data management, statistical and programming work. In addition, this individual will create, develop, validate and maintain all programs for assigned projects in compliance with standard operating procedures.
· In-House Clinical Research Associate – #1834 - Northern NJ – Responsible for Sponsor oversight of clinical site monitoring to ensure successful execution of the protocol. Additional responsibilities include support of the CRO in oversight of site monitoring and monitoring performance metrics, and issue escalation and corrective actions, and implementation of enrollment and recruitment strategies. The In-house CRA will support the development of study-specific tools for the sites and CRA use, review trip reports, and support other objectives for the Clinical Project Team, as needed.
· Clinical Project Manager – #1833 - Northern NJ – Responsible for managing global 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.
· Director, Clinical Research – Neuroscience – Alzheimer’s Disease – #1823 – Northern NJ – Responsible for providing medical expertise for directing and implementing clinical research plans and programs according to established design principles, making preparations for registration dossiers and Advisory Committee Meetings, and communicating with Health Authorities in support of a global submission. The incumbent will serve as both the Medical Monitor for the overall Program and as a Study Director MD required.
· Manager or Senior Manager, Clinical Pharmacology – #1800 – North Carolina – Responsible for working with senior clinical pharmacologists to develop clinical pharmacology plans and oversee the execution of these plans across therapeutic areas and in all phases of clinical development. The employee will be an integral member of the project team and serve as the clinical pharmacology lead for individual asset(s) and also provide critical and strategic input into the clinical pharmacology aspects of late phase studies. The employee will work under the supervision of senior clinical pharmacologists to design and interpret clinical pharmacology studies and write relevant sections of regulatory documents, protocols, and study reports. The employee will also assist in due diligence efforts for potential acquisition of products and/or technologies.
· Director, Medical Affairs – #1799 – Northern NJ – Will fulfill a liaison role between commercial supporters’ grant administration and the Company by developing needs assessments/gap analyses in a variety of areas, including but not limited to: cardiology, endocrinology/diabetes, narcolepsy and sleep disorders, and hematology and oncology, among others. Pharm.D. or Ph.D. required. Preferred: 5+ years experience at an ACCME-accredited medical education company (MECC); 5+ years experience in Cardiology, Endo/Diabetes, Sleep Medicine or combination thereof; 5+ years experience writing / reviewing independent medical education grants.
· 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.
· Director Clinical Research & Development Neuroscience – #1770 – Northern NJ – Growing, mid-sized pharma company needs experienced MD to lead a Clinical Program through global registration. Will support multiple NDAs and all facets of the CDP and Drug Development program as well as new opportunity evaluations. MD required with Board Certification in Internal Medicine or Neurosciences (eg Psychiatry). Possible Therapeutic areas include epilepsy and Neuorpathic pain. Must have pediatric study experience. Should have 5 + years of neuroscience clinical research in a pharmaceutical environment; will consider candidates with prior early or later phase experience
Medical Education/ Communication Agencies (eMarketing)
· Director, Medical Education – #1806 – NYC – Develops and grows business relationships with current and prospective pharmaceutical and medical device clients (supporters) in the assigned territory in order to generate new medical education funding opportunities for the organization.
· 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, Consumer Marketing– #1941– Northern NJ– The Senior Director, Consumer Marketing is a key leadership role within the Company. This individual is responsible for the development and execution of the patient and caregiver strategy and plan. This critical organizational position requires a dynamic and talented entrepreneur that has not only the unique ability to think strategically, but can also think creatively, and apply this innovative thinking to the development and execution of the operational plans.
· NEW – Sr. Director, Digital Marketing– #1940– Northern NJ– The Senior Director, Digital Marketing is a key leadership role within the Company. This individual is responsible/participates in the development and execution of a wide range of strategic and operating plans. This critical organizational position requires a dynamic and talented entrepreneur that has not only the unique ability to think strategically, but also execute plans with excellence.
- NEW – Sr. Manager, Multichannel Marketing– #1937– Northern NJ– Lead the strategy and implementation of a range of programs critical to meeting top-line and bottom-line objectives for each Brand team. MCCM Planners work closely with Brand teams within a specific Therapeutic Area or Franchise
- NEW – 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.
- NEW – 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.
- GI Marketing Product Manager – #1925– Central NJ– Develops all marketing strategies, objectives, and promotional materials for assigned products. In addition, this role develops LCM (life cycle management) plans that include new business development, and phase 3 development for assigned products/franchises. They will also manage the company’s advertising agency and other vendors on associated projects, and conduct market research to determine product sales potential and develop marketing strategies.
- Health Economics and Outcomes Research Director, Oncology – #1922– Northern NJ– Responsible for development and execution of high quality HEOR strategic efforts to support multiple Oncology brands in the US Market, with focus on real world evidence generation, health economics, and patient-reported outcomes. This position requires a proven track record of HEOR evidence generation and the ability to lead or collaborate with cross-functional teams on efforts to improve market access and patient care.
- Alliance Management, Senior Manager – #1921– Northern NJ– This position will ensure the proactive management and smooth functioning of alliances and collaborations. You will work with the partner companies to establish and maintain the strategy, cultural alignment, direction and scope for implementation and maintenance of our collaborative agreements, including defining key activities and their respective timelines, and assigning responsibilities between the partners. You will also take the lead on issues and risks (typically cross-functional) requiring alliance consensus or decision, including gaining internal company consensus by involving key players and ensuring speedy and appropriate decisions.
- Portfolio Manager/Associate Director – North America Generics – #1918– Central NJ– This role supports new product identification/ideation, selection, prioritization, and development efforts for the NAG business unit. It involves managing and coordinating the US generic product portfolio through assessment of market landscape, development cycles and submission timing by working with cross functional teams including formulation development, regulatory affairs, patent litigation, medical affairs, sales and marketing.
· GI Marketing, Product Manager or Sr. Product Manager– #1904– Central NJ– Develops all marketing strategies, objectives, and promotional materials for assigned products. In addition, this role develops LCM (life cycle management) plans that include new business development, and phase 3 development for assigned products/franchises. They will also manage the company’s advertising agency and other vendors on associated projects, and conduct market research to determine product sales potential and develop marketing strategies.
- Brand Manager, Eye Vitamins Marketing– #1903– Central NJ– The Brand Manager, Eye Vitamins Marketing will drive brand-specific initiatives for the fast-growing eye vitamins brand, the largest in the US.
- Marketing Manager (Diagnostics)– #1896 – North Central NJ– supports the franchise GM / Product Director for a specific assigned offering (a set of tests, services and solutions) that could be defined around patient group/call point/clinical area. They coordinate development, deployment and post marketing surveillance of the offering, and generally ensure an integrated marketing plan is in place to achieve their assigned goals. The product manager also works to build the business case and secure resources for new initiatives. Some of the key partners day to day will be the Process Excellence project managers, Science and Technology leaders, select Operations and IT functions, Marketing Communications team members and Specialty Sales director.
- 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.
· Safety Solution Architect – #1915– Northern NJ – The Safety Solution Architect will lead a team that is aligned to the product safety business functions and other business functions and will work with business stakeholders to design a technical solution to meet the strategic needs of the business. In this role, he/she will provide leadership in process analysis, process and system design and development, to identify, recommend, develop, implement and support cost-effective technology solutions in one or more business functions. The Solution Architect is responsible for analyzing wider industry trends, best practices, and emerging technologies and assessing applicability to the Company. This role conceives and drives innovative solutions aligned with business objectives and assists the business in defining value propositions for current and future investments. The Solution Architect leads the efforts in providing integrated systems analysis and recommending appropriate hardware, software, and communication links required to support IT goals and strategy. This includes providing project leadership, coordinating activities of the project team and assisting in the monitoring of project schedules and costs.
· NEW – Director, Specialty and Innovative Products Analysis – #1942 – Northern NJ – The Director will utilize analytical skills to support decision making and development of key commercial strategies for specialty and innovative products in the pipeline. Activities will include procurement and analysis of appropriate secondary data sources, management of primary research projects and development/updating of commercial assessments and forecasts. This role reports to the Vice-President of Commercial and will require interaction with groups across the Company, including senior-level executives in Clinical, Corporate Strategy and Innovative Development.
Market Access/Managed Care
· Market Access, Director or Senior Director – #1916 – Northern NJ – The Director Market Access, Strategic Planning & Payer Marketing, Oncology is responsible for developing the strategies (in alignment with brand) to drive market access for the oncology brands in all commercial and government channels. In addition to helping set the strategy, this role will also be responsible for identifying innovative opportunities. The role leads deployment of appropriate tactics and monitoring of critical success factors to ensure progress and successful outcomes against the plan are being achieved. The role will be responsible for identifying gaps in progress and finding solutions to address any such gaps. This position is highly visible and will report directly into the EVP of Market Access and serves on the group’s executive leadership team.
· 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 – Senior Medical Writer – #1934 –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.
- Senior Medical Writer – #1861 – Central 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.
· NEW – Associate Director, Cinical Pharmacovigilance – #1939 – Upstate NY/Northern NJ – Responsible for the oversight of safety reporting activities for clinical programs in accordance with FDA and international regulations, guidances and guidelines, and Company policies and procedures. Responsible for management of personnel assigned to these activities
- NEW – Senior Manager, Program Finance – #1933– Upstate NY/Northern NJ – The Program Finance Senior Manager is the dedicated "Therapeutic Area CFO" for development all programs within assigned therapeutic areas, providing value-add analyses and interpretation for relevant stakeholders, primarily Senior Management and external collaborators. As a member of the Program Finance Leadership Team, the Program Finance Senior Manager implements best practices and standardization to drive efficient management across their therapeutic areas. The position has three direct reports and is responsible for workload allocation and people development of their team.
- Commercial Contracts Manager – #1920 – Central NJ – This position will be responsible for managing commercial contracts for North America Generics (NAG),including Rx, OTC, and Health Systems customers in various classes of trade including, but not limited to wholesalers, distributors, retailers, mail order facilities, hospital and specialty pharmacies, GPOs, IDNs, etc. The candidate will communicate directly with clients and internal cross functional groups, to develop, amend, review, maintain, and analyze contracts.
- Finance and Commercial Operations Manager – #1919 – Central NJ – This position will be responsible for managing financial account disputes for North America Generics (NAG) customers in various classes of trade including wholesalers, retailers, mail order facilities, GPOs, etc. to resolve financial discrepancies while providing coordination & guidance to both domestic and international cross-functional groups.
· Senior Director – Intellectual Portfolio – #1898– Northern NJ – Give strategic direction to the generic business by identifying and executing IP driven opportunities and with respect to product selection, suggesting new areas to venture from an IP perspective, performing IP risk analysis and providing FTO clearance on product development strategies for the US, EU, Canada markets
· Business Development – #1913 – Northern NJ – Two Openings for leading Managed Markets/Market Access Agency: (1) East Coast and (2) West Coast – 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 a plus.
- Senior Account Executive– #1910 – Northern NJ– The Senior Account Executive (SAE) will implement/manage client projects and assure timely, high quality client deliverables. The SAE manages the project life cycle, using approved techniques and tools to achieve milestones and deliver results. The SAE drives the daily activities of the project, communicating with key internal service delivery personnel, as well as managing scope change and timeline inhibitors and is responsible for implementing projects in such a way as to promote and assist the success and profitability of all support projects. The SAE will report directly to the Account Supervisor, and is responsible for completing work accurately to execute projects according to an established project plan and timeline.
- Director Strategic Accounts – #1786 – NYC – The position requires a sales executive to build relationships with top interactive agencies that represent these clients. 5-10 years interactive sales experience calling on all levels of marketing professionals with both Clients and Agencies. Requires strong relationship building skills, knowledge of interactive media buying and selling. Knowledge of the Pharma space is a plus.
- Director, Sales Strategy and Strategic Accounts – #1692 – NYC – Responsible for supporting the development and deployment of new sales strategies and solutions that leverage the Company’s core assets and capabilities to grow market share. This position will focus on overall Company solutions and for a large, strategic business partner. Development of these solutions requires deep working knowledge of the digital media industry and evolving commercial models with an emphasis on data and analytics. The right candidate will quickly assess and understand cross-functional dynamics, priorities and capabilities; he/she will synthesize marketplace needs and opportunities to influence Product, Content and Marketing Sciences roadmaps to drive market deployment of leading sales solutions.
· NEW – Executive Assistant to the Founder– #1938 – Northern NJ– Provide executive level administrative support to the CEO of a fast-growing Biotech company
Ruderfer & Associates, Inc.
Tel: (973) 239-2000