Oversee and lead a team of 4-6 staff responsible for regulatory review and approval of commercial materials and interactions with the FDA Office of Prescription Drug Promotion (OPDP) for respective products. Staff also oversees all regulatory operational management of commercial materials (Veeva Vault an electronic document management system, submission of all materials to FDA, applicable processes and SOPs). Provides strategic regulatory advice on advertising and promotion materials and activities for assigned products in accordance with business goals and objectives, FDA regulations/guidelines, PhRMA guidelines and company policy. Influences teams for assigned products and projects to implement compliant product labeling and communications. Accountable for the smooth operation of the company’s Materials Approval and Review Committees (MARC) process. The MARC scope includes Promotional, Scientific and Corporate communications. All relevant products or candidates are in the hematology/oncology space.
Key Accountabilities/Core Job Responsibilities:
Serves or manages staff responsible for regulatory advertising and promotion review for assigned products on MARC teams. This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance.
Oversee or manage interactions with OPDP regarding advertising and promotion for assigned products. Establishes strong and positive working relationship with OPDP reviewers.
Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks.
Provide promotion integrity advice and guidance on the development of the draft labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based.
Participates in US labeling negotiations and FDA meetings as necessary.
Ensures that changes in US Prescribing Information are reflected in current promotions and advertising.
Understands global promotional strategies and provides solution to local US regulatory promotional issues.
Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted.
Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by attendance of major FDLI, DIA and other industry/FDA meetings.
Oversee and manage staff responsible for all operational processes and procedures related to the review/approval of materials with the purpose of promoting, advertising or providing information about the Company and the Company’s products.
Provide educational training for local regulatory staff, contractors and others regarding company policies and procedures within the scope of the Regulatory Affairs Advertising, Promotion.
Candidate to assist with additional regulatory projects as needed.
Must perform independently with strong problem solving, negotiation and decision making skills by balancing autonomy and teamwork.
Must possess strong interpersonal, collaboration and communication skills.As a team captain for PRC and a team member, requires the ability to be both a team leader and a team player.
Excellent verbal and written communication skills. Ability to represent regulatory in cross-functional teams. Strong interpersonal skills and ability to work in a small/medium size company setting.
Excellent knowledge and understanding of US regulations for drug promotion/advertising and US labeling, prior experience in oncology or hematology drugs strongly preferred.
Experience in the regulatory review of professional and consumer Rx drug advertising and promotion.
Experience in leading activities necessary for promotional OPDP submissions (including pre-clearance and 2253, “time of first use” submissions).
Experience with regulatory activities involved with a product launch.
Strong understanding of business goals of the involved business franchise, marketing concepts and tools.
Excellent project management skills with the ability to collaborate and manage with all stakeholders to adhere to timelines and deadlines. Work independently on assigned projects within timelines. Great attention to detail and ability to interpret clinical and scientific data
BA/BS required, advance allied health degree such as MS, PharmD, MD, PhD highly beneficial.
Minimum of 7+ years of relevant Regulatory Affairs, Advertising and Promotional Materials experience in the pharmaceutical/biotechnology industry, ideally prior experience with Orphan Drugs and Subpart H approval.
We exist to make a difference for the better and these are important times to do just that. Our mission is to build a viable biopharmaceutical company that designs, develops and commercializes novel therapies intended to improve quality of life, increase duration of life and resolve serious medical healthcare needs.
At Pharmacyclics, we intend to create medicines that improve both the quality ...and duration of patient lives. This requires hard work, sacrifice, money, organization, communication, affinity for what we do and a willingness to be of service to others.
We measure our progress by the number of patients benefitting from our medicines.