For the safety of our employees and communities in response to COVID-19, ACADIA has implemented a temporary work from home policy. As a part of this shift, we have migrated all interviews to virtual interviewing via phone and video.
Responsible for managing the promotional review process including facilitation of review meeting and tracking of all materials throughout the review and approval process by closely interacting with relevant departments, agencies and management teams to meet commercial and corporate objectives.
- Medical, Legal & Regulatory(MLR):
- Single point of contact for all Veeva MLR submissions, tracking, approvals and review of Form 2253 regulatory transfers for FDA‘s Office of Prescription Drug Promotion (OPDP) submission.
- Schedule and facilitate all MLR meetings taking into account timelines/prioritization for all projects and keeping a future MLR calendar of future projects.
- Capture changes/edits during MLR meetings.
- Route and monitor promotional review materials, including initiating the re-reviews, in the Veeva Vault electronic review system. Ensure the correct team reviewers are assigned.
- Work closely with the reviewers, project originators, ad agencies, and editors to resolve any questions or issues.
- Request Veeva Vault access and training for new users.
- Update and maintain MLR Activity Tracker.
- Manage proofing of digital materials and back up for print production materials.
- Coordinate schedule of OPDP submissions with Regulatory.
- Provide notification of release of materials to project originators and agencies.
- Related duties:
- Proactively manages enhancements for PromoMats by soliciting feedback and partnering with IT for implementation.
- Communicates project timelines to brand managers and agencies to manage competing commercial objectives.
- Manages process and timelines related to promotional labeling updates and projected forecasts of MLR volume.
- Supports goals for Marketing Operations, reflecting clear alignment with the Commercial organization’s strategic priorities.
- Establishes collaborative relationships with the Commercial team and agencies through frequent communication and interaction to understand needs and optimize effectiveness.
- Supports the department’s working relationships with MLR committee to optimize effectiveness, efficiency and productivity.
- Other duties as assigned.
Bachelor’s degree in marketing, health care, business administration or related required; or an equivalent combination of relevant education and applicable job experience may be considered. A minimum of 5 years’ experience in the pharmaceutical industry in a variety of progressively responsible and related positions. Experience in positions related to supporting field sales or marketing operations strongly preferred. Specific experience supporting or working with promotional review committees highly desired. Experience with Veeva PromoMats and an understanding of regulatory, legal and medical requirements for pharmaceutical marketing strongly preferred.
- MS Office proficiency in Outlook, Word, PowerPoint and intermediate skill in Excel
- Strong written and verbal communication skills with the ability to manage information flow among a variety of stakeholders
- Strong team and interpersonal skills, works cooperatively with others, establishes rapport, while identifying needs of others
- Strong organizational abilities
- Self-directed with sense of urgency with commitment to tasks at hand
- Strong business sense to grasp big picture while maintaining details
- Ability to easily adapt to new technology
- Ability to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information
- Ability to promote team cooperation and a commitment to team success.
May provide guidance to subordinates and/or manage department section, to achieve goals in accordance with established policies and to meet schedules and/or resolve problems. Receives assignments in the form of objectives. Follows processes and operational policies in selecting methods and techniques for obtaining solutions; determines how to use resources to meet schedules and goals. Works on issues of diverse scope which require evaluation of a variety of factors and an understanding of functional area objectives and trends. Erroneous decisions or failure to achieve results may add to costs and impact the short-term goals of the organization.
While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds.
ACADIA is an Equal Employment Opportunity/Affirmative Action Employer: Minority/Female/Disability/Veterans/Sexual Orientation and Gender Identity