Sr Medical Writer - Fsp

3+ years

Not Disclosed

Remote

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: Senior Medical Writer (FSP; Remote)
Work Schedule: Other
Environmental Conditions: Office

Job Description:

At Thermo Fisher Scientific, you’ll find meaningful work that creates a positive global impact. Join us in bringing our mission to life—enabling customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while advancing scientific research, development, and delivery of life-changing therapies. With clinical trials conducted in over 100 countries and ongoing development of innovative frameworks for clinical research through our PPD clinical research portfolio, your dedication to quality and accuracy will improve health outcomes for communities around the world.

Summarized Purpose:
We are seeking a Senior Medical Writer to support one or more clients in the FSP space, preferably with experience in Neuroscience. This is a remote position available from any location in EMEA. As a Senior Medical Writer on the FSP team, you will provide high-quality medical and scientific writing from planning through to delivery of final drafts for both internal and external clients, potentially across multiple FSPs. You will foster effective communication and collaboration to achieve operational excellence.

Essential Functions:

Serve as the primary author for FSP clients, writing and providing input on routine documents such as clinical study reports and study protocols, and summarizing data from clinical studies.
Research, write, or edit complex clinical and scientific documents, including Investigator's Brochures (IBs), Investigational New Drug applications (INDs), and Marketing Authorization Applications (MAAs).
Review routine documents prepared by junior team members and provide training and mentorship on document preparation, software usage, regulatory requirements, and therapeutic area knowledge.
Ensure compliance with quality processes for assigned documents and contribute to the development of best practices and techniques for optimal results.
Assist in program management activities, including developing timelines, budgets, forecasts, and contract modifications, while identifying and resolving out-of-scope activities.
Represent the department at project launch meetings, review meetings, and project team meetings.

Education and Experience:

Bachelor's degree in a scientific discipline or equivalent; advanced degree preferred.
5+ years of regulatory writing experience, with hands-on experience in Clinical Study Reports (CSRs), protocols, IBs, narratives, summaries, and regulatory submissions.
Experience in peer review and quality review of medical writing documents.
Excellent business communication skills.
Project management or mentoring experience is a plus.
Experience in the pharmaceutical/CRO industry is preferred, along with familiarity working within FSPs.
Additional qualifications in medical writing (AMWA, EMWA, RAC) are advantageous.

Knowledge, Skills, and Abilities:

Excellent data interpretation and medical writing skills, including grammar, editorial, and proofreading abilities.
Strong project management skills and excellent problem-solving capabilities.
Strong negotiation and communication skills, with the ability to present effectively.
Significant knowledge of global and regional document development guidelines.
In-depth expertise in specialty areas such as preclinical, therapeutic, or regulatory submissions.
Excellent judgment, decision-making skills, and proficient computer skills, including knowledge of document management systems and applications (e.g., Excel, Outlook).

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. You will benefit from an award-winning learning and development program that supports your professional and personal growth. We offer competitive salaries, an extensive benefits package, and a flexible working culture that values work-life balance. Our collaborative environment fosters sharing of expertise and camaraderie among colleagues.

Our mission is to enable our customers to make the world healthier, cleaner, and safer. Join us as part of a team of over 100,000 colleagues, united by shared values of Integrity, Intensity, Innovation, and Involvement, as we accelerate research, solve complex scientific challenges, and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued.

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Sr Medical Writer - Fsp

Job Description

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