Executive Director of Medical Writing
15 hours ago
MapLight Therapeutics, Inc. is seeking an experienced Executive Director of Medical Writing to join our team. As a key member of our Regulatory Affairs department, you will be responsible for establishing and overseeing our medical writing function, ensuring the accuracy and quality of submission-ready documents, and collaborating with subject matter experts on document development and review.
Responsibilities:- Develop and implement a writing strategy to ensure timely completion of medical writing deliverables, including the identification, selection, and oversight of qualified medical writers, vendors, consultants, or contractors.
- Lead the development of clear and concise clinical, nonclinical, and regulatory documents, ensuring consistency of messaging/content across all documents supporting regulatory submissions.
- Responsible for ensuring the accuracy and quality of submission-ready documents using established and effective writing processes.
- Coach, develop, and support employees in the medical writing function.
- Oversight of team members to perform weekly literature searches.
- Responsible for clinical trial transparency and disclosures, including clinical trials results posting on, EudraCT, and similar databases worldwide, in collaboration with Regulatory Affairs.
- Develop and implement document templates, style standards, reference library, reviewer guidelines, and quality control checklists, to ensure consistent and high-quality deliverables.
- Ensures development and maintenance of relevant SOPs and internal best practices.
- Has flexibility to react rapidly to changing situations/environment. Will plan strategically, anticipate problems, and recommend process improvements to address current and future needs.
- Bachelor of Science with significant relevant writing experience, or Bachelor degree in English or communications with significant relevant science experience.
- A relevant advanced degree (e.g. MS, PharmD, PhD, MD) is preferred.
- American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
- Minimum of 10 years of relevant medical/regulatory writing experience in the pharmaceutical industry required, or in a related area such as regulatory, clinical research, or product support/R&D.
- Minimum of 5 years of regulatory document project management experience with extensive experience in working with collaborative, cross-functional teams.
- Extensive knowledge of English grammar and American Medical Association (AMA) style guide.
- Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers/vendors.
- Demonstrated track record of contribution to successful regulatory components used in filings e.g., IND/CTAs, NDA/BLA/MAAs.
- Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology.
- Advanced knowledge of US and international regulations, requirements and guidance associated with scientific publications or regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
- Knowledge and expertise with Common Technical Document content templates, electronic document management systems and information technology.
MapLight Therapeutics, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
-
Executive Director of Medical Writing
5 days ago
Burlington, Vermont, United States MapLight Therapeutics, Inc. Full timeAbout the RoleWe are seeking an experienced Executive Director of Medical Writing to join our team at MapLight Therapeutics, Inc. As a key member of our Regulatory Affairs department, you will be responsible for establishing and overseeing our medical writing function, ensuring the accuracy and quality of submission-ready documents, and collaborating with...
-
Executive Culinary Director
1 week ago
Burlington, Vermont, United States Affinity Executive Search Full timeJob Description**About the Role**Ambitious and experienced culinary professionals are sought after by Affinity Executive Search to fill a challenging and rewarding position as an Executive Culinary Director. This role will be responsible for managing the culinary and production activities within a small food production environment.Key Responsibilities:Manage...
-
Executive Director of Operations
2 weeks ago
Burlington, Vermont, United States PC Construction Company Full timeJob DescriptionPC Construction Company is seeking a seasoned Executive Director of Operations to drive business performance and growth. This key executive leadership role is responsible for overseeing and managing the day-to-day operations, providing strategic direction to the company, and partnering with the CEO and executive team.Key...
-
Executive Director of Operations
2 weeks ago
Burlington, Vermont, United States OhMD Inc Full timeJob DescriptionJob Title: Executive Director of OperationsCompany: OhMD IncLocation: RemoteJob Type: Full-timeAbout Us:OhMD Inc is a leading patient conversation company dedicated to improving healthcare through innovative communication solutions. We're seeking a highly skilled Executive Director of Operations to join our team and drive our mission...
-
Attending Physician
1 week ago
Burlington, Vermont, United States Theoria Medical Full timeJob SummaryWe are seeking an experienced Attending Physician to join our team as a Medical Director for skilled nursing facilities. As a key member of our leadership team, you will be responsible for providing high-quality patient care, leading quality initiatives, and collaborating with our Nurse Practitioners and Physician Assistants.Key...
-
Development Director
7 days ago
Burlington, Vermont, United States MENTOR Vermont Full timeAbout the RoleMentor Vermont is seeking a highly skilled Development Director to lead our fundraising efforts and external stakeholder communication. As a key member of our team, you will play a critical role in securing the resources needed to support our mission of strengthening the quality and reach of mentoring relationships in Vermont.Key...
-
Burlington, Vermont, United States Aon Full time{"title": "Managing Director of Captive and Insurance Management", "description": "About the RoleAon is seeking a seasoned professional to lead our captive and insurance management operations in Vermont. As a Managing Director, you will be responsible for driving strategic and operational improvement initiatives, delivering on financial and operational...
-
Director of Environmental Initiatives
3 weeks ago
Burlington, Vermont, United States Lake Champlain Committee Full timeAbout the OpportunityThe Lake Champlain Committee is seeking a visionary leader to serve as its Executive Director. As the chief administrative agent of the organization, the Executive Director will be responsible for leading the LCC's mission to protect Lake Champlain's environmental integrity and recreational resources.Key ResponsibilitiesStrategic...
-
Development Director
6 hours ago
Burlington, Vermont, United States MENTOR Vermont Full timeAbout MENTOR VermontMENTOR Vermont is a statewide non-profit organization dedicated to strengthening the quality and reach of mentoring relationships in Vermont communities. As an affiliate member of MENTOR: National, we are part of a national network invested in high-quality mentoring relationships and closing the mentoring gap.Job SummaryWe are seeking a...
-
Burlington, Vermont, United States Aon Full timeAbout the Role:Aon is seeking an experienced Executive Director to lead our Captive and Insurance Management operations in Vermont. As a key member of our team, you will be responsible for driving strategic and operational improvement initiatives, delivering on financial and operational targets, and maintaining a compliance culture in line with Aon Group and...
-
South Burlington, Vermont, United States Korn Ferry Executive Search Full timeAbout the Organization Imagine a world where fundamental challenges to global sustainability and social equity are addressed at their core. For over 26 years, Population Media Center has empowered communities to transform attitudes and behaviors, fostering a healthier, more equitable, and thriving planet, particularly focusing on women and girls. Population...
-
Chief Executive Officer
3 weeks ago
Burlington, Vermont, United States Seven Days Jobs Full timeSeven Days Jobs is seeking a dedicated and visionary Chief Executive Officer to lead our organization in driving impactful community engagement and advocacy. As a prominent non-profit entity, we are committed to fostering systemic change on critical social justice matters. Key Responsibilities: Provide comprehensive leadership and strategic direction for...
-
Burlington, Vermont, United States Aon Full timeAbout the Role:Aon is seeking an experienced Executive Director to lead our Captive and Insurance Management operations in Vermont. As a key member of our team, you will be responsible for driving strategic and operational improvement initiatives, delivering on financial and operational targets, and maintaining a compliance culture in line with Aon Group and...
-
South Burlington, Vermont, United States Korn Ferry Executive Search Full timePosition OverviewAbout the OrganizationEnvision a world where critical challenges to global sustainability and social equity are addressed at their core. For over 26 years, our organization has motivated communities to transform attitudes and behaviors, fostering a healthier, more equitable, and thriving world, particularly in regions where health and...
-
Burlington, Vermont, United States InsideHigherEd Full timeLead Residential Learning CommunitiesAs a key member of the Department of Residential Life, the Associate Director of Residential Learning and Academic Engagement will lead the development and implementation of residentially-based Learning Communities (LCs) that support the department's vision and strategic objectives. This role will oversee academic...
-
Executive Support Specialist
2 weeks ago
Burlington, Vermont, United States The Flynn Full timeAbout The FlynnThe Flynn is a dynamic organization dedicated to enriching the community through the arts. We are seeking a highly skilled and organized individual to join our team as a Workflow Ambassador.Key ResponsibilitiesProvide administrative support to the Executive Director, ensuring seamless day-to-day operations.Act as a communications liaison for...
-
Executive Director of Fitness Operations
2 weeks ago
South Burlington, Vermont, United States Fitness Holdings North East LLC Full timeJob OverviewAt Fitness Holdings North East LLC, we are seeking a highly motivated and experienced Executive Director of Fitness Operations to lead our team of professionals in delivering exceptional fitness experiences to our members.About the RoleAs a key member of our leadership team, you will be responsible for driving revenue growth, team development,...
-
Chief Executive Officer
3 weeks ago
Burlington, Vermont, United States Navion Senior Living Full timeNavion Senior Living is seeking a dynamic leader to fill the role of Executive Director. The ideal candidate will be a strategic thinker and a skilled manager capable of inspiring and guiding all staff members within the organization. The Executive Director will be responsible for overseeing all community operations and ensuring optimal financial...
-
Burlington, Vermont, United States InsideHigherEd Full timeJob SummaryWe are seeking a highly motivated and experienced professional to serve as the Associate Director of Residential Learning and Academic Engagement. This role will lead residentially-based Learning Communities (LCs) in support of the Department of Residential Life's vision and strategic objectives.Key ResponsibilitiesLead the Learning Communities...
-
Burlington, Vermont, United States InsideHigherEd Full timeJob SummaryWe are seeking a highly motivated and experienced professional to serve as the Associate Director of Residential Learning and Academic Engagement. This role will lead residentially-based Learning Communities (LCs) in support of the Department of Residential Life's vision and strategic objectives.Key ResponsibilitiesLead the Learning Communities...
