Global Head of Medical Writing US - Vaccines

, PA, United States

Global Head of Medical Writing US - Vaccines page is loaded Global Head of Medical Writing US - Vaccines Bewerben locations Swiftwater, PA time type Vollzeit posted on Vor 3 Tagen ausgeschrieben job requisition id R2745682 Job title: Global Head of Medical Writing US - Vaccines

Location: Swiftwater, PA

About the Job:

Under the direction of the Global Head of Medical Writing & Translation, you will lead and manage a team of professional Medical Writers (MW) in the U.S. and France engaged in the planning, authoring, compilation, review, and approval of medical, scientific, regulatory documents supporting vaccine development and licensure. You will work in close collaboration with the other managers in Clinical Programs and Clinical Sciences to accomplish business objectives. You will also represent the MW platform in key meetings to define platform strategy and provides guidance and leadership in development medical writing related processes.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

Coordinates and ensures delivery of Medical Writing activities and deliverables

Plans and manages the day-to-day assignment of work to individual medical writing team members. This includes writing of clinical study protocols, study reports, Phases I-IV, informed consent documents, investigator’s brochures, briefing packages and clinical CTD summary documents.

Ensures that MW complete all required documentation related to their work on clinical documents including filing required documents to the TMF.

Provides guidance on interpretation of ICH guidelines and regulations on authoring of clinical documents

Ensures proactive, timely reporting on progress of operational components (quality, compliance, performance), communicates operational opportunities and risks to the Global Head and other appropriate individuals within the Clinical Programs and Clinical Sciences organization.

Contributes to the development of the outsourcing strategy for the global platform

Identifies the needs for contracted resources or for outsourcing to CRO partners.

Ensures activities related to his/her platform are conducted with optimum quality and efficiency, meet global regulatory requirements, company SOPs, and are in alignment with the overall Clinical Sciences/Programs strategy and priorities

Responsible for the management of a global team of medical writers

Leads and manages the Medical Writing team; responsible for recruitment, management and development of medical writers globally.

Focuses on developing skills and capabilities that support strategic goals and objectives of the organization.

Attracts, motivates and retains qualified staff to ensure the attainment of Medical Writing goals and objectives

Coaches and mentors team members

Ensure training requirements are appropriately followed and tracked at the platform level

Process and Continuous improvement

Leads/Contribute to the development of appropriate templates and guidelines to ensure a consistent and compliant approach to the writing of clinical documents.

Establishes culture of continuous learning and improvement

Stays abreast of new regulatory guidance and industry-wide initiatives that impact Medical Writing and recommends appropriate actions

Identifies process issues requiring resolution at the platform level and proposes solutions

About You:

An advanced degree in Science with expertise in the writing of clinical regulatory documents used to support clinical development and licensure.

Two to three years’ experience directly managing medical writers engaged in the preparation of CTD submissions and other regulatory documents.

Knowledge of Vaccine Clinical Development is an asset.

Willingness to travel internationally on occasion.

Why choose us?

Bring the miracles of science to life alongside a supportive, future-focused team.

Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.

Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.

Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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Sanofi

Why Sanofi As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.

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