Job Information
PDS Tech Inc Medical Affairs Information (Mid)-Med Affairs & Pharma-R&D-PH-US in Whippany, New Jersey
PDS Tech, Inc. is seeking Medical Affairs Information (Mid)-Med Affairs & Pharma-R&D-PH-US
Local candidates Hybrid role/Whippany Location Purpose:
The Senior Manager/Associate Director, Medical Affairs Communications, is responsible for managing all Medical Affairs Communications functions within a given therapeutic area, or specific assigned product.
This includes responsibility for specific products within the therapeutic area.
The Senior Manager/ Associate Director is responsible for providing accurate, timely, unbiased, and up-to-date medical & scientific information to internal and external customers.
The incumbent carries out this role in accordance with departmental SOPs, company corporate policy, and other legal & regulatory requirements, and also supports the strategy and successful implementation of medical content creation and approval and in close collaboration with global and country medical colleagues, securing a seamless execution of relevant processes to support the evolution of USMA medical communication team.
This individual will work with different teams within and outside of Medical Affairs to drive the internal and external facing of US Med Com initiatives.
Key Tasks:
Provides the medical information review of advertising and promotional materials on their assigned therapeutic areas, ensuring that information is scientifically accurate and medically appropriate.
Directs or participates in the approval process for custom and standard inquiry responses.
Reviews all standard responses within the therapeutic area of responsibility for accuracy, relevance, and timeliness prior to final approval by the Director or Senior Director.
Guides Medical Information personnel such that accurate and up-to-date information are provided to external customers and supervises and facilitates the search, review and interpretation of medical and scientific data.
Leads or participates in the Medical review and approval of all Advertising & Promotion and Sales Training materials. Medical Affairs representative for LMR (Legal, Medical, Regulatory) team for assigned products and or therapeutic area.
Reviews the scientific literature to develop content for new Medical Content standard letters and FAQs and revisions of existing letters for a company disease state area combining clinical experience with critical analysis of clinical literature to synthesize an appropriate solution to a customer-specific, drug related problem while keeping within legal and regulatory guidelines.
Respond to verbal, written, and electronic medical/product inquiries from Healthcare Professionals, (e.g., Physicians, Pharmacists, Nurses), Consumers, accounts, Insurance and Government personnel that have been escalated from Customer Care Services (Call Center).
Actively participate in marketing brand product teams, communications committees, product advisory board meetings, and other company meetings to ensure that the MC scientifically accurate public health message supports business unit goals and is aligned to promotional materials and campaigns.
Champion regular meetings with Medical Affairs (Medical Affairs, HEOR, MSLs,) and other business partners (Safety, Product Quality Complaints, Sales, Sales Training, Marketing) to ensure the safe and appropriate use of company products assuring public health-oriented responses and to assure the key medical messages are consistent and accurate throughout the company.
Drives transformational initiatives (such as localization on global medical materials and potential adoption of new technologies) ensuring successful evaluation, execution, and optimization of resources and services
In collaboration with senior director/director med coms, He/She manages allocated budget for assigned projects
Manages the Medical Affairs booth for company products at Medical and Scientific conventions and
conferences.
Research review relevant and present background information and scientific literature regarding investigator sponsored studies proposals.
Understands and utilizes all appropriate information technology applications in the discharge of responsibilities.
Performs work within IT systems that is aligned with approved procedures and with continuing efforts to improve efficiency.
Key Working Relation: Medical Communication Senior Directors & Directors Medical Information Directors, Call Center Director and Deputy Director Medical Information Specialists, TA Medical Directors, MSL Directors, Head US Med Affairs, Head of Medical Operations, and Global Scientific communication teams (SBU or MATA team)
Qualification & Competencies:
Healthcare Professional (PharmD, PhD, MD) with at least 2-3 years experience within a pharmaceutical or medical device company; or equivalent clinical experience required.
Experience in a formal drug information center or equivalent clinical experience required.
Excellent oral and written communication skills are required.
Knowledge of FDA regulations regarding the dissemination of Medical Information, drug promotion and adverse event and product quality complaint reporting is required.
Computer proficiency required.
Proven track record of successfully implementing scientific communication projects for [associate director]
Project management skills. Strong for associate director
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.