Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. Our priority is to bring important new therapeutics to patients
in need. In order to do so, we must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics. Akcea has a portfolio of development-stage drugs covering
multiple targets and disease states using advanced antisense therapeutics.
Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Boston, MA with offices in Carlsbad, CA and across the EU and Canada.
Director, Global Regulatory Advertising and Promotional Compliance
The Director, Global Advertising and Promotional Compliance serves as the Regulatory Affairs (RA) representative on product promotion review teams, medical review teams and the Investigator Sponsor Trial teams. The Director has responsibility for reviewing
and approving the regulatory content of US materials created for product promotion, disease awareness and public affairs communications. The director will also play an active role in formalizing the process for review of such materials outside of the US.
The Director will participate in developing processes and procedures relevant to the creation, review and approval of promotional materials. The Director also acts as the primary liaison with FDA on regulatory issues concerning promotional materials.
Job Duties & Responsibilities
- Reviews US promotional, disease awareness, public affairs and medical materials and ISTs, attends promotional review meetings and provides regulatory guidance to the cross-functional team responsible for ensuring material compliance with global compliance
standards and FDA regulations pertaining to prescription drug advertising and promotion, as applicable
- Participate in cross-functional team to formalize the process for review of promotional materials outside of the US
- Serves as primary contact for communications with the Office of Prescription Drug Promotion (OPDP) for assigned products, including responsibilities for the timely preparation and submission of promotional materials under cover of FDA Form 2253
- As needed, provides training support within Akcea on regulatory requirements for prescription drug promotion including, but not limited to, sales training and compliance training in preparation for scientific conferences
- Liaise with Regional experts globally on requirements for ex-US promotional guidelines
- Bachelors’ Degree
- Minimum 8+ years of pharma experience
- Solid knowledge of U.S. advertising and promotional regulations
- Direct experience communicating and negotiating directly with OPDP
- Experience with global standards for advertising and promotion compliance
- Proven track record practicing sound judgment as it relates to risk assessment
- Knowledgeable on industry compliance requirements and non-compliance examples and trends
- Demonstrated ability to influence others and foster team collaboration
- Strong interpersonal, communication and leadership skills.
- Proven ability to prioritize and meet critical business timelines
- JD, PharmD or Masters’ Degree
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.