Employee Type: Full-Time
Posting ID: 6877667
Pay Rate: $0 – $180,000/Year
Job Summary
3 FULLY REMOTE Global Labeling Strategist – Assoc. Director /Director positions with a Large Global pharmaceutical company for a long-term partnership with a highly innovative sponsor!
This is a 100% Home office based (anywhere) – fully work from home position! Will need to work East coast hours for conf calls and calls with Japan.
Overview: Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components. Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)
Culture: fast paced, innovation and technology focused organization, detail oriented. Personality is important as they have a great company culture, value their employees and encourage a collaborative environment along with independence
Terms: EASi Sciences engagement; 2-year renewable contract + 10 days accrued PTO days + company holiday schedule (10 paid holidays); Year over year increase potential; performance reviews and increases, etc.
Responsibilities:
- Leads preparation, review, and update of content for the development and maintenance of labeling and labeling components.
- Develop and maintain Target Product Profile, Company Core Data Sheet (CCDS) and local labels (US, EU, Canada)
- Evaluate and communicate risks associated with CCDS content updates and implementation strategies
- Understand and address key scientific, clinical, medical and payer needs, including commercial differentiation strategies
- Assess competitor labeling – understand precedents & opportunities for Health Authority (HA) discussions
- Understand implications for promotional and HTAs from local labeling
- Support global HA interaction strategy to discuss key labeling elements
- During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
- Develop clear communications for senior management and SOP approvers to streamline and facilitate final label negotiations and approval
- Contributes to the continuous improvement of the end-to-end labeling process
Must Haves:
- Sr. Manager or Associate Director level Labeling candidate with at least 5 years of experience
- Able to write and design new label templates
- Safety and Legal background
- Strategy (not operations) focused
- Able to lead a team
- Able to facilitate change cross-functionally
- Design work instructions, SOPs, and initiate process improvement
About Aerotek:
We know that a company’s success starts with its employees. We also know that an individual’s success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek’s people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek’s 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.