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Icf Medical Writing Program Manager

2+ years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: ICF Medical Writing Program Manager
Work Schedule: Standard (Mon-Fri)
Environmental Conditions: Office

Job Description:

At Thermo Fisher Scientific, you’ll engage in meaningful work that positively impacts global health. Join our team in fulfilling our mission: enabling customers to create a healthier, cleaner, and safer world. We provide our teams with the resources necessary to achieve their career goals while advancing science through the research, development, and delivery of transformative therapies. With clinical trials in over 100 countries and ongoing advancements in clinical research through our PPD portfolio, our work spans laboratory, digital, and decentralized clinical trial services. Your commitment to quality and accuracy will enhance health outcomes for communities worldwide.

Discover Impactful Work:
Lead patient-centric medical writing programs focusing on Informed Consent Forms (ICFs). Manage complex projects, engage with clients, and ensure flawless delivery and quality of documents, contributing to world-class research outcomes.

A Day in the Life:

  • Develop and adapt project plans and timelines.
  • Engage and manage client relationships.
  • Collaborate with cross-functional teams.
  • Monitor project progress and provide status updates.
  • Mentor junior staff and ensure compliance with quality processes.

Keys to Success:

  • Advanced project management skills.
  • Outstanding planning and organizational abilities.
  • Excellent communication, negotiation, and decision-making skills.
  • In-depth knowledge of regulatory and document development guidelines.
  • Proven ability to lead and mentor junior staff.

Education:

  • BS/BA (preferably in a scientific field) with a minimum of 8 years of relevant experience, or an advanced degree with a minimum of 6 years of relevant experience.

Experience:

  • Experience managing medical writing or clinical projects.
  • Experience in the pharmaceutical/CRO industry.
  • Preferably, experience in medical writing (Regulatory and/or plain language).

Knowledge, Skills, and Abilities:

  • Advanced skills in budgeting, forecasting, and resource management.
  • Expert planning and organizational skills.
  • Excellent interpersonal and communication skills.

Physical Requirements / Work Environment:
This role is office-based, with flexibility for remote work as needed. Candidates must manage strict deadlines and juggle multiple projects simultaneously.

Benefits:
We offer competitive remuneration, an annual incentive plan bonus, healthcare, and a range of employee benefits. At Thermo Fisher Scientific, you’ll find an innovative, forward-thinking organization with outstanding career and development prospects. Our company culture emphasizes integrity, intensity, involvement, and innovation.

Our Mission:
To enable our customers to make the world healthier, cleaner, and safer. Join us and discover five reasons to work with us. As one team of 100,000+ colleagues, we uphold values of Integrity, Intensity, Innovation, and Involvement, collaborating 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

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