Tech Observer
Global Medical Affairs Manager-FSP
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Tech Observer is looking for a Global Medical Affairs Manager who will play a critical role in supporting the clinical development, evaluation, and communication of scientific evidence for nicotine replacement therapy (NRT) products and other drug products. This individual will critically appraise scientific literature, develop strong medical and scientific narratives to support regulatory submissions, and oversee key evidence-generation activities in collaboration with external partners and vendors. This role is being established to support Tech Observer's clients' global Medical Affairs capability during a period of significant portfolio growth and increasing evidence-generation needs. The position will provide critical scientific leadership across multiple priority programs, help build scalable Medical Affairs capabilities, and ensure continuity of medical support and evidence strategies across key growth platforms. This is an excellent opportunity for a highly motivated, self-driven professional looking to contribute to impactful work in a dynamic, science-driven environment.
Location
- Morristown, NJ (Hybrid 2 days WFO)/
- London, UK (Hybrid 2 days WFO)/
- Canada (Remote)
About the Role
Scientific & Medical Expertise
Responsibilities
- Review, critically analyze, and synthesize scientific literature related to nicotine replacement therapy and other drug products, including clinical, pharmacological, social behavioral science, health economics, and real-world evidence.
- Translate complex scientific data into clear, concise, and compelling medical summaries and insights for cross-functional stakeholders.
- Support global promotional material review and assemble product claims substantiation documents in accordance with applicable guidelines, legal, and regulatory frameworks.
- Support the development and maturation of global Medical Affairs capabilities, processes, tools, and best practices across the portfolio.
- Support scientific leadership and mentorship to cross-functional teams to elevate evidence-generation, scientific communications, and claims substantiation capabilities.
- Partner with R&D, Regulatory Affairs, Commercial, and Medical Affairs leadership to identify capability gaps and implement sustainable solutions that support future portfolio growth.
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Medical Writing
- Develop high-quality medical writing deliverables to support regulatory submissions and health authority interactions.
- Craft scientifically robust and well-structured arguments based on integrated inputs from stakeholders and external scientific key opinion leaders to support product claims, ensuring alignment with applicable requirements.
Evidence Generation & Study Management
- Develop study plans and oversee external vendors conducting different kinds of clinical development or product development studies such as:
- Pharmacokinetic (PK) and pharmacodynamic (PD) modeling
- Bioequivalence (BE) studies
- Product sensory studies
- Other clinical and non-clinical evidence generation activities
- Ensure studies are executed to high scientific and quality standards, on time, and within scope.
- Collaborate with internal stakeholders (e.g., R&D, Regulatory, Clinical Operation, Marketing, Legal) to ensure alignment of study objectives and outputs.
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Key Opinion Leader (KOL) & Healthcare Professionals (HPC) Engagement
- Identify, build, and maintain relationships with key opinion leaders (KOLs), investigators, and relevant academic research centers in the field of scientific interest.
- Leverage external expertise to inform evidence generation strategies, clinical study design, and scientific positioning.
- Facilitate scientific exchange and collaboration to support research initiatives, publications, and broader medical affairs objectives.
Qualifications
Education
- Advanced degrees in a health or life sciences field required: PharmD, PhD, MD, MSc, or RN (or equivalent).
Experience
- Minimum of 2 years of relevant experience in the pharmaceutical or consumer health industry (or completion of a relevant post-graduate fellowship program).
- Experience in medical affairs, clinical research, or evidence generation strongly preferred.
Required Skills
- Strong ability to critically evaluate and interpret scientific literature.
- Excellent medical writing skills with the ability to build clear, evidence-based arguments.
- Familiarity with PK/PD modeling and bioequivalence concepts is highly desirable.
- Proven ability to manage external vendors and complex projects.
- Strong organizational skills and attention to detail.
- Excellent communication and stakeholder management skills.
- Self-starter, proactive, and highly motivated with the ability to work independently.
Tags
#ClaimSubstantiation
#ScientificCommunication
#ScientificWriting
#Regulatorysubmission
#PK/PD
#BE
#bioequivalence
#MedicalAffairs
#Consumerhealth
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