Job Description
Pay: $60 - $70/Hour
Duration: 8-9 months
Location: Remote CST or EST
Description:
Responsibilities:
Minimum requirements:
Preferred Background:
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#LI-DP1
Duration: 8-9 months
Location: Remote CST or EST
Description:
- The Labelling Strategy Associate Director provides regulatory labelling expertise, typically for more complex drug projects, to the Global Regulatory Submission Team (GRST)/Global Regulatory Execution Team (GRET), and cross functional Product Labelling Teams (PLT).
- This individual leads the development/implementation of the labelling strategy and maintenance of Core Product Information and United States (US) /European Union (EU) Market Product information (MPI) for assigned company marketed or pipeline products. The individual contributes to the Development of the labelling group by sharing knowledge and mentoring peers.
Responsibilities:
- Ensures that the labelling process is followed through the lifecycle of the product.
- Ensure all work is performed in accordance with established procedures, regulatory requirements and GxPs.
- Leads the development of the labelling strategy, in line with the overall regulatory strategy for the product, by interpretation of regulations, guidance and competitor analyses, anticipating and communicating the wider impacts of the strategy and the long-term consequences for the product and the wider AZ portfolio.
- Leads the PLT in the preparation and maintenance of high-quality Core Prescribing Information, EU Quality review of Documents (QRD), US Prescribing Information (PI), Instructions For Use (IFUs) through to Senior Leader approval with the aim of achieving advantageous labelling.
- Leads the development of labelling negotiation strategies, anticipating HA perspectives.
- Provides labelling expertise to the GRST/GRET/PLT for assigned products regarding language, placement and regulatory content detail for CPI and MPI in line with company procedures, regional labelling regulations and guidance.
- Provides clarity regarding applicable labelling requirements and expectations in complex situations to relevant stakeholders, including risk insight and proposing mitigations
- Evaluates, interprets and communicates global regulations and trends on labelling and any business impact these might have on product labelling
- Ensures appropriate communication across Labelling subfunctions
- Able to justify and communicate the labelling rationale to Senior Leaders to enable effective decision making.
- Leads the development of target labelling documents as appropriate
- Assist in the development of labelling policies, procedures and SOPs
Minimum requirements:
- Hands-on Strategic Labeling Experience
- Minimum of 3+ years of direct experience in regulatory pharmaceutical labeling strategy (developing prescribing information, core data sheets, or US/EU package inserts).
- Must be able to hit the ground running without needing training on core labeling concepts.
- Global / International Experience: Experience collaborating with international teams across different time zones (US, Europe, Spain, Sweden, Canada, India) and working with external pharmaceutical partner companies.
- Pharma / Biotech Industry Background: Direct experience within a GxP/regulated pharmaceutical environment.
- Bachelor’s Degree in Science or related discipline
Preferred Background:
- Experience in Labelling development and/or maintenance
- Knowledge of major markets Labelling regulations
- Advanced academic training is highly desirable (PharmD, PhD)
- Primary system is ERV (an internal electronic repository based on Veeva Vault).
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy at Privacy Policy
#LI-DP1
Numbers & Facts
| Location | Gaithersburg, MD (Remote) |
| Industry | Staffing/Employment Agencies |
| Salary | $60–$70 Per Hour |
| Company Size | 500 to 999 employees |
| Website | https://www.thefountaingroup.com/ |
About Company
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.
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