A global specialty pharmaceutical company is looking for an interim professional to support commercialization of their generic product(s). This a relatively small part of the client’s business that they’d like to expand. The ideal candidate will lock in initial contacts and support initial bids with wholesalers. This Interim will manage existing customers (price, orders, etc.), develop and implement strategies to expand customer basis, and lead price and agreement negotiations. This role is also responsible for long- and short-term revenue forecasts, supporting profitability/pricing and financial analysis, and attending main trade and customers’ events.
- Extensive experience with commercialization of generic products (U.S.).
- Excellent knowledge of U.S. generic market (Wholesalers, GPOs, PBM, etc.).
- Good commercial network (Customers and Payors).
- Ability to work autonomously.
- Knowledge of financial analysis.
- Ability to work and interact with CFO and CEO.
- 40 hours/week, can be remotely based. Some travel required.
This role directs all regulatory activities for new and existing products to ensure alignment and compliance with FDA laws and guidances and local regulatory requirements, as well as Company policies. This role will develop and oversee the implementation of regulatory strategies in support of the Company’s development and marketed product programs. Additionally, this position will provide regulatory direction and support to ensure compliance in areas of advertising, promotion labeling, Chemistry, Manufacturing and Controls (CMC), and other activities related to the commercialization of US marketed products.
- Bachelor and/or Advanced Degree in a scientific field with 12+ years in a Regulatory Affairs function within the pharmaceutical industry. CMC experience preferred.
- Formulate, communicate and implement regulatory strategy for assigned programs to meet regulatory requirements and achieve established project milestones and Corporate objectives.
- Support regulatory activities from development through post-approval, including; interfacing with regulatory authorities, preparation of regulatory documentation, critical review of regulatory dossiers and query response strategies and execution; oversight of labeling processes for marketed products; and oversight of regulatory guidance, review and submission of advertising and promotional materials.
- Ensure that all plans and activities for and on behalf of the Company are carried out with the “best” industry practices and the highest ethical standards.
Reporting to the Chief Medical Officer, the Medical Director will be responsible for the ‘hands on’ development and implementation of clinical development activities. The Medical Director will provide leadership and policy direction to ensure the client meets and/or exceeds organizational goals. The successful candidate will provide strategic and tactical oversight, medical input, advice and key opinion leader interaction, concerning: Project planning for clinical trials and development programs, protocol development and review and medical review of ongoing trials.
- Requirements include a demonstrated understanding of, and the ability to interpret, GCP/FDA standards/guidelines, as well as a clear understanding of internal/external resource management. The selected candidate will possess a strong desire to work in an innovative, emerging growth company environment.
- M.D. Board certified with relevant clinical experience in areas related to client programs.
- 7+ plus years of pharmaceutical/biotech experience in clinical drug development, including direct experience managing, planning, organizing, implementing, and completing clinical trials supporting product registration.
- Clinical experience in rare diseases or therapeutic areas of interest preferred.
This person will serve as a member of the Promotional Review Committee (PRC) and will collaborate with originators and cross functional teams in the development of new promotional campaigns. Reviews supporting materials ensuring compliance and consistency with internal policies, Code of Federal Regulations (CFR), FDA guidance documents, and the Federal Food, Drug, and Cosmetic Act. Negotiates promotional regulatory position within cross-functional teams and is responsible for regulatory activities for the client’s commercial products including review and submission of advertising and promotional materials, directing the labeling change control process, and life cycle management activities.
- Bachelor and /or Advanced Degree in a scientific field with 7+ years in a Regulatory Affairs function within pharmaceutical products industry.
- Proficient knowledge of cGMP’s, FDA labeling, advertising and promotion regulations is required.
- Experience with physician sampling programs a plus.
- Experience writing regulatory submissions for new drugs (NDA supplements) and ensuring that submissions meet ICH and FDA guidelines.
- Experience with eCTD submissions to FDA.
- Proficient knowledge of FDA requirements for drug marketing and advertising.
Located in NJ, the Product Manager will play a critical and central role in the final product definition and product launch process for the client’s digital/chemical indicator product line. The role has responsibility for the complete life cycle of the product including developing and executing go-to-market plans for all new products and services within this product platform. With accountability for market shaping ensuring products are launched into marketplace successfully, this role requires a combination of strong marketing skills, project/program management, consensus building, and the ability to coordinate resources from a variety of supporting teams. The Product Manager is also responsible for developing the business case and business model by talking to customers, learning the market, collaborating with executives and peers and collaborating with the Innovations team to develop and commercialize the product.
- Greater than 9 years product marketing/product management experience with minimum of 5 years in a technical product category (RFID, bar code technology, asset tracking).
- Expertise in project management cycles and deliverables for hi-tech products.
- Knowledge of product and operational marketing, market studies, pricing, products, promotions, distribution and statistical tools.
- Demonstrated management success in cross-functional collaboration.
THESE ARE ONLY OUR FEATURED CAREERS
CONTACT ASHTON TWEED FOR MORE OPEN CAREER OPPORTUNITIES
Phone: (610) 725-0290
Fax: (610) 975-0291
Ashton Tweed, Ltd.
565 E. Swedesford Rd.
Wayne, PA 19087