Regulatory Med Writer

Job Description

At Thermo Fisher Scientific, you’ll 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.

Division Specific Information

Under minimal supervision, the Medical Writer critically evaluates, analyzes, and interprets the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.

Discover Impactful Work:

Utilizes professional judgment and creative expertise to integrate the pertinent clinical data into an original summary document that is clear, accurate, concise, comprehensive, and devoid of promotional overtone. Provides evaluation of medical communication instruments and makes recommendation for corrective action. Assumes responsibility for ensuring that the finished document is complete, accurate and complies with approved format.

A day in the Life:

• Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols and summarizes data from clinical studies.
• Researches, writes, edits complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.
• Reviews routine documents prepared by junior team members. May provide training and mentorship for junior 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. Provides input on and independently develops best practices, methods and techniques for achieving optimal results, including various client-specific processes.
• May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
• Represents the department at project launch meetings, review meetings, and project team meetings.

Keys to Success:

Education

• BS degree in pharmacy or Doctoral level degree in a biomedical field

Experience

• Experience within regulatory medical writing (comparable to 2 years) required.
• 2 years experience in searching the biomedical literature
• 2 years experience in interpreting and using medical communication documents

Knowledge, Skills, Abilities

• Knowledge of biomedical and pharmaceutical databases (e.g. MEDLINE, CANCERLIT, EMBASE, BIOSIS, IPA) and vendors for accessing them (e.g. DIALOG, OVID, SILVERPLATTER)
• Knowledge of Boolean logic/operators
• Knowledge of medical terminology and basic statistical/clinical concepts
• Problem-solving capabilities and excellent organizational skills
• Excellent grammatical and communication skills
• Writer skills, i.e. command of outlining, drafting, revising, and reviewing
• Basic editorial and proofreading skills
• Detail-oriented.
• Able to work with minimal supervision
• Ability to prioritize
• Adaptable and flexible in nature
• Computer skills [word processing, spreadsheet, bibliographic management]
• Good interpersonal skills.
• Ability to work within a team

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!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Accessibility/Disability Access

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*This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Salary : $40 - $0