JOIN OUR TEAM! PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. What we offer: Competitive salaries Ability to earn additional income based on hours worked (Biweekly basis) Free High-Quality webinars provided by experts from around the world Committed to keeping our consultants in project continuity Referral Program Wellness Program Recognition Program (for employees only) Service Award Program (for employees only) Discount Program (for employees only) An administrative team that is oriented in providing excellent service that pursues satisfying the needs of our consultants. For our projects in the US, we cover travel/lodging/transportation expenses (employees only SUMMARY Primary responsibilities include: Supporting the product company's client complaint system through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions promptly. FUNCTIONS - Keep the complaints database updated as soon as factual information is available and summarize closed investigations into the database accurately. - Ensure complaint-related investigations are concise, clear and, science-based by reviewing and approving such investigations. - Follow-up on corrective actions derived from investigations through completion. - On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation. - Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers. - May also include Communication and escalation of complaints, site representation on the product complaint network, and generation and issuance of closure letters to patients and business partners. EDUCATION/LICENSES - Doctorate or Master's degree and 3 years of directly related experience to the job or Bachelor's degree and 5 years of directly related experience to the job or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience. COMPETENCIES/SKILLS - Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must. - Excellent written and verbal communication skills, including facilitation and presentation skills. - Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups. - Be self-motivated, able to interface effectively with various levels, attentive to details, and able to prioritize and meet deadlines, and must possess excellent leadership, problem-solving, analytical, influencing, and customer service skills to operate and deliver results in a matrix-managed GMP environment. - Computer literacy, independently understanding, follow, and implement instructions, work or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions, and determine when to escalate, as necessary. Good fit if you have these experiences: 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry Bachelor's Degree in a Science Field Ability to oversee multiple projects simultaneously Ability to successfully manage workload to timeliness Familiarity with basic project management tools Ability to negotiate a position after taking feedback from multiple sources Demonstrated ability to consistently deliver on-time and high-quality results Ability to operate in a matrixed or team environment Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing processes) PharmaLex is an Equal Opportunity Employer. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law. Powered by JazzHR
