Associate Manager Medical Communication preparing clinical and regulatory documents for medical technology firm. Ensuring compliance with medical device regulatory requirements and mentoring junior staff.
Responsibilities
Prepares complex clinical and regulatory deliverables in accordance with internal GSOPs and applicable regulatory guidelines with minimal oversight
Authors clinical documentation including Literature Review Protocols and Reports, Clinical Evaluation Plans, Clinical Evaluation Reports, Summary of Safety and Clinical Performance, and Post-Market Clinical Follow-Up Plans and Reports
Develops additional deliverables such as clinical study reports, investigator brochures, manuscripts, posters, abstracts, publication plans, and internal white papers
Performs and documents methodologically sound literature searches and critically evaluates peer-reviewed clinical data
Maintains compliance with European, Australian, Canadian, and U.S. medical device regulatory requirements
Partners with subject matter experts and external vendors to develop technical content that meets regulatory and business needs
Mentors junior staff and helps develop templates, tools, SOPs, and best practices
Requirements
Bachelor’s degree (BA/BS) required; advanced degree (PhD or PharmD) preferred
Minimum of 8 years of industry experience (5 years with PhD/PharmD)
At least 5 years as a medical writer
Advanced medical writing
Regulatory knowledge
Project management
Strong attention to detail
Proficiency with MS Office and reference management tools
Senior Payments Manager overseeing payment operations and relationships with payment service providers in Limassol. Managing transaction processing and compliance in a hybrid work environment.
Country Manager responsible for business development in the offshore wind energy sector. Leading a team while managing client relationships, marketing, and partnerships.
Bid Manager responsible for managing complex projects at Vestas, a leader in wind energy. Collaborating with sales teams and ensuring competitive offers in project execution.
Site Manager overseeing service operations for wind turbines at Vestas. Mentoring team members for optimal performance and ensuring client satisfaction in renewable energy.
Manager leading process innovation initiatives for Customer Solutions at Asurion. Driving operational improvements and collaborating with cross - functional teams to enhance efficiency.
Grants Manager B role at University of Pennsylvania overseeing grant portfolio and compliance management for research activities. Collaborate with faculty and ensure adherence to sponsor regulations.
Lab Manager overseeing day - to - day operations of SAFE Lab. Responsible for supervising MSW students and managing research initiatives at the University of Pennsylvania.
Service Delivery Manager managing end - to - end service lifecycle across federated supplier ecosystem for ITV. Ensuring high - quality service delivery and driving continuous improvement.
Manager in Interpath's CII team advising major UK businesses on complex restructuring and insolvency solutions. Leading engagements and supporting junior team members in high - profile assignments across jurisdictions.
Assistant Traffic Manager supporting marketing and digital campaigns for Undiz. Responsible for advertising and performance analysis with various channels.