Principal Medical Writer

This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
Standard (Mon-Fri)  Environmental Conditions
Office

Job Description

At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future.

Summarized Purpose:

We are excited to expand our Medical Writing FSP Team in APAC! This would be a remote role working from any location in APAC. We are looking for a Principal Medical Writer to be dedicated to a client in the FSP space; experience in Immunology, Oncology or Vaccines would be valuable but not essential. As a Principal Medical Writer you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients.

As the lead writer, you will review documents for the team and provide training and guidance to junior team members. As a subject matter expert you will provide advice on document development strategy, regulations, and industry best practices. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

Key Responsibilities:

Researches, writes, and edits clinical study reports and study protocols, and summarizes data from clinical studies.
May serve as primary author who writes and provides input on complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
Provides senior level review of routine and complex documents. Provides training and mentorship for other writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
Ensures compliance with quality processes and requirements for assigned documents. As the subject matter expert, develops and reviews best practices, methods, and techniques for achieving optimal results, including various client- specific processes, and leads process improvement initiatives. May also develop, review, and manage performance metrics for assigned projects.
May serve as backup program manager. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications, and assisting business development with client presentations and proposal text review, and attending bid defense meetings and capabilities presentations.
Represents the department at project launch meetings, review meetings, and project team meetings.

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification required;
Advanced degree preferred
8+ years regulatory MW experience. strong working experience in Authoring CSR, Protocol, ICF, IB and other regulatory documents
Experience in managing and directing complex medical writing projects required.
Experience working in the pharmaceutical/CRO industry required.
Submissions document experience advantageous.
Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous

Knowledge, Skills, and Abilities:
Significant knowledge of global, regional, national, and other document development guidelines
In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
Excellent project management skills
Advanced interpersonal, oral, and written communication, and presentation skills
Excellent negotiation skills
Excellent judgment; high degree of independence in decision making and problem solving
Ability to mentor and lead junior level staff.

What We Offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an  award-winning learning and development programme , ensuring you reach your potential.
As well as being…