Cambridge, Massachusetts

Kelly is hiring an Associate Director of Medical Information and Review
  • Can be remote
  • 6 month contract; Possibility of extension but may need to relocate if looking for a full time role after the contract
  • Pay $70-89/hr
  • Support 3 products
  • Small team with 5 people 
  •  PharmD or PhD is sufficient, MD not needed



The Associate Director Medical Information and Review, will serve as a functional expert in the area of Medical Review for their assigned products/ Therapeutic Areas and ensure alignment, integration, for process and technology efficiencies in activities across therapeutic areas for Global and US Medical Affairs Oncology.

The Medical reviewer is responsible for performing accurate and detailed scientific/medical re-view of non-promotional/medical affairs generated materials within Global and US Medical Affairs as well as promotional materials generated by the Global and US Commercial teams. He/she pro-vides timely and accurate reviews of these materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. He/she ensures Takeda non-promotional/ promotional materials convey accurate, correct and balanced medical/ scientific messages. In addition they must excel in providing advanced medical and scientific review of medical affairs materials and, if required, promotional materials to support the medical and promotional review processes.

The Associate Director Medical Review will manage resources (whether internal or outsourced) and become the key point of contact for US commercial (USRC), for medical (OMRC) and for global commercial (GRC) review committees. He/She would also manage the vendor(s) that are involved in the medical review process of non-promotional and promotional materials, ensuring a best in class and cost effective solution is implemented.

Lastly it may be required support Medical Information and Review needs and activities for other brands and pipeline products, as well as above brand activities to ensure a best in class medical Information and review function, ensuring Takeda Oncology’s professional standing and integrity with patients, healthcare professionals and the pharmaceutical industry.

 

ACCOUNTABILITIES
• Responsible for ensuring the scientific information contained in Takeda’s global non-promotional and promotional materials (eg, medical communication materials, training materials, and advisory board materials) is accurate, not misleading and is medically relevant.
• Verify the content of promotional material is truthful, balanced, scientifically rigorous, and is consistent with approved product labeling.
• Acquire and maintain expert understanding of product, associated disease states, relevant literature, treatment guidelines, and thorough knowledge of the label for assigned therapeutic area.
• Serve as the key point of contact for US commercial (USRC), for medical (OMRC) and for global commercial (GRC) review committees.
• Manage the vendor(s) that are involved in the medical review process of non-promotional and promotional materials.
• Serve as an expert to internal stakeholders on general and specific Medical Review practices and regulations across the pharmaceutical industry. Evaluate best practices from other organizations and develop implantation strategies for Oncology.
• Ensure content is well-substantiated by scientific data (verifying the content is accurately cited/properly referenced); check authenticity and validity of references; deter-mine that references in promotional materials specifically support product claims made in the material; and ensure the context of the reference is appropriately reflected in the promotional claim(s) in the material.
• Verify scientific content is understandable by the intended audience.
• Reviews materials to anticipate potential risk to the product/ company. Works collaboratively to resolve potentials legal, regulatory issues. Recognize when to escalate to manager/ leadership team to resolve higher risk issues.
• Understand that recommendations, actions and decisions made for promotional materials are critical in ensuring compliance with applicable regulatory/practice standards pertinent to the promotion of pharmaceutical products.
• If needed/appropriate, support content development of global Medical Information responses/activities and additional duties as assigned, e.g. attendance in medical booths
• Coach and mentor interns, fellows, students and Medical Information & Review team members.

DIMENSIONS AND ASPECTS
• Creativity and innovation: Proven ability to think outside the box and challenge status quo is mandatory.
• Strategic Approach: Ability to adjust to changes in the business landscape due to increasing understanding and ongoing assessment of the environment.
• Engage Others: Ability to participate on teams effectively with a focus on delivering results
• Collaboration: Ability to cultivate a broad network of relationships throughout the organization
• Lead Change: Ability to adjust to changes in functional or cross-functional plans and priorities in response to changes in strategic direction
• Drive for Results: : Execute on strategies and goals that are closely aligned with company objectives, and deliver on metrics that track and assess performance.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Required:
• The qualified candidate should have an advanced degree (PhD, PharmD or equivalent) in a scientific discipline (preferred) or a minimum of Bachelor’s degree in a scientific discipline plus commensurate long-term experience within pharmaceutical or biotech industry with a thorough grasp of the pharmaceutical industry.
• 5+ years of healthcare or related experience (managed markets, clinical practice, research or academic) including 3+ years of medical information and review experience within the pharmaceutical industry.
• Excellent written and oral communication skills

 

Preferred Training/Experience:
• Demonstrated results in one or more medical information and review groups
• Oncology experience strongly preferred
• Firm Understanding of pharmaceutical clinical development and product life-cycle management.
• Cross-functional team participation within the Pharmaceutical or related industry.
• Board Certification in therapeutic area of interest.
Pharmaceutical Industry Acumen: Strong understanding of regulatory and compliance environment

ADDITIONAL INFORMATION
• Ability to drive to or fly to various meetings or client sites, including overnight trip. Ability to drive to or fly to various meetings or client sites, including overnight trips. Requires approximately 10-20% travel



Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly®

At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Cambridge, Massachusetts

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