FSP- Scientific Writer- Regulatory at Thermo Fisher Scientific in collegeville, Pennsylvania

Job Description:

Work Schedule

Standard (Mon-Fri)



Environmental Conditions

Office



Job Description



Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.


Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.


Discover Impactful Work:


The Scientific Writer assists in the preparation and review of scientific documents under general supervision to meet or exceed quality standards. Writes and edits basic to moderately sophisticated analytical methods, reports and protocols for potential submission to regulatory authorities.


A day in the Life:

• Prepares and/or assists in the preparation of scientific documents such as methods, protocols, reports, method development summaries, analytical methods, SOPs, client correspondence and other similar documentation.


• Compiles laboratory data into a specified report format. Ensures that hardcopy and electronic reports are consistent and align with required formats. Reviews data tables and listings and ensures that errors are corrected. Performs a quality control review of scientific documents prior to creation of the final pdf result. Ensures compliance with PPD, Client, eCTD policy and procedure on publications.


• Reviews scientific documents for accuracy, formatting, consistency and compliance to protocols or SOPs


• Keeps updated on the guidelines and requirements of the FDA and other international regulatory agencies for reference in the development of required documents.


• Develop and maintain a detailed CMC regulatory dashboard to support program timelines, deliverables, and risk profiles across the portfolio.


• Interact with CMC regulatory affairs personnel to gain knowledge on timelines and resource needs across the biopharmaceutical portfolio.


• Identify and evaluate options for eliminating resource bottlenecks among regulatory submission projects.


• Manage health authority questions (HAQ) database. This includes entering new questions and ensuring entries are complete.


• Contribute to regulatory submission authoring and editing as needed to support submission writing teams and regulatory templating activities.


• Have experience in the biotechnology environment and a strong desire to learn about the biopharmaceutical development process and regulatory affairs.


• Possesses a robust capability for writing, complemented by a critical editorial perspective.


• Showcase an ability to independently advance objectives developed with management.


• Demonstrates an eagerness to acquire proficiency in emerging software and visualization technologies.


• Show strong organizational skills and meticulous attention to detail.


• The competence to operate effectively without established guidelines or procedures.


• Aptitude for tracking down information through diligent communication and coordination

Education and Experience

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification


• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years') or equivalent combination of education, training, & experience

Knowledge, Skills, Abilities

• Good working knowledge of scientific terminology, medical, pharmaceutical and research concepts


• Good knowledge of word processing, spreadsheets, table and graph generation and use of applicable computer software


• Working knowledge of industry regulations, ICH or other regulated environements


• Working knowledge of analytical laboratory procedure


• Effective written and oral communication skill


• Time management skills


• Good editorial and proofreading skills


• Good problem solving and troubleshooting abilities

Physical Requirements / Work Environment



Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.


• Able to work upright and stationary and/or standing for typical working hours.


• Able to lift and move objects up to 25 pounds.


• Able to work in non-traditional work environments.


• Able to use and learn standard office equipment and technology with proficiency.


• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.


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Benefits



We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! Apply Now