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Senior Manager, Medical Affairs
2 months ago
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Job Title: Senior Manager, Medical Affairs
Location: Boston, MA (Hybrid)
Job Description
The Senior Manager of Medical Affairs will play a crucial role in ensuring the strategic alignment and operational excellence of medical information and communications within the US Medical Affairs organization. Reporting to the Director of Medical Affairs, this role will oversee medical review and approval processes, develop comprehensive communication strategies, and ensure adherence to regulatory standards across medical affairs initiatives.
Key Responsibilities
Develop and implement communication strategies for medical affairs initiatives, aligning them with the medical strategy and regulatory guidelines.
Translating of complex scientific and clinical data into clear and compelling messages for various stakeholders. Collaborate closely with cross-functional teams including Medical Affairs, Clinical Development, Regulatory Affairs, and Legal.
Manage the creation, production, and update of scientific materials, including publications, medical education resources, training/onboarding materials, standard response documents, booth materials, and slide decks for scientific presentations. Ensure consistency and accuracy of medical information across all communication channels, including digital platforms.
Support the planning and execution of advisory boards, scientific conferences, symposia, and other events, including content development, logistics coordination, and KOL engagement.
Represent Medical Affairs at key meetings and business initiatives, providing expertise and insights into medical information and communications strategies.
Responsible for all medical communications activities, adhering to relevant regulations and guidelines, such as Good Publication Practice and industry codes of conduct. Serve as the internal product expert and medical reviewer for company-developed materials globally and in the US, ensuring scientific accuracy, alignment with medical strategy, and compliance with regulatory requirements as part of Medical Legal Review (MLR) and Promotional Review Committee (PRC).
Manage relationships with external vendors and agencies, including medical writers and event management companies, to support medical communications initiatives effectively.
Approve materials for external use, including scientific publications, medical education materials, and presentations, ensuring they are fair-balanced and supported by current literature.
Facilitate cross-functional and team meetings, preparing agenda and action items, and ensuring resolution of those action items.
Assist in the monitoring and administration of the departmental budget, including preparing cost estimates to assist with budget recommendations.
Manage procurement and vendor management processes, including coordinating and reviewing contracts, securing purchasing orders, and overseeing invoice submissions.
Provide operational support of systems (including Veeva CRM, Within3, etc.). Develop new workflows and best practices as needed to support the needs of a growing medical team and for launch preparation.
As needed, provide MSL coverage to key accounts within local and regional territory to build relationships with key opinion leaders
Skills and Qualifications
Advanced scientific degree (PharmD, MD, PhD) required.
5+ years of overall experience in Medical Affairs, Medical Communications, or related field within the pharmaceutical or biotechnology industry.
Experience in medical review and approval processes preferred, with a track record of maintaining scientific and regulatory accuracy required.
Prior experience launching biologics/rare disease products preferred.
Prior experience in immunology or dermatology preferred.
Strong understanding of medical affairs functions, clinical development processes, and regulatory requirements.
Excellent written and verbal communication skills, with the ability to distill complex scientific information for diverse audiences.
Proven ability to manage multiple projects simultaneously, prioritize effectively, and deliver high-quality work within established timelines. Strategic thinker with the ability to align medical communications objectives with overall business goals.
Strong attention to detail and commitment to maintaining scientific and regulatory accuracy.
Ability to work effectively in cross-functional teams and collaborate with stakeholders at all levels.
Proactive, adaptable, and able to thrive in a fast-paced and dynamic work environment.
Ethical standards and adherence to compliance guidelines.
Travel is estimated at 30% of time for conferences and meetings as needed.
What we offer in return
You will be working for an organization that embraces diversity & inclusion and believe we will deliver better outcomes by reflecting the perspectives of our diverse customer base. You will also have access to a range of company benefits, including a competitive wage with shift differential, annual bonus opportunities and career advancement and cross-training.
Next Steps
If your profile is a match, we will invite you for a first virtual conversation with the recruiter.The next step is a virtual conversation with the hiring managerThe final step is a panel conversation with the extended team
Our people make a difference
At Galderma, you'll work with people who are like you. And people that are different. We value what every member of our team brings. Professionalism, collaboration, and a friendly, supportive ethos is the perfect environment for people to thrive and excel in what they do.
Employer's Rights:
This job description does not list all the duties of the job. You may be asked by your supervisors or managers to perform other duties. You will be evaluated in part based on your performance of the tasks listed in this job description. The employer has the right to revise this job description at any time. This job description is not an employment contract, and either you or the employer may terminate employment at any time, for any reason. In addition, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
