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    Program Manager - Medical Writing | Fsp

    Thermo Fisher Scientific
    7+ 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: Program Manager, Medical Writing FSP Team
    Work Schedule: Other
    Environmental Conditions: Office

    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 advancing science through the 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, your dedication to quality and accuracy will improve health outcomes for communities worldwide.

    Summarized Purpose:
    We are excited to expand our Medical Writing FSP Team in India and seek a Program Manager dedicated to a client in the FSP space. Experience with Structured Content Authoring systems and AI-driven content creation is preferred. In this role, you will support innovative solutions in medical writing, leading high-visibility client programs that require extensive engagement and management. You will oversee planning, monitoring, and adapting client and program-specific processes, including new technology implementation.

    Essential Functions:

    • Serve as a subject matter expert, collaborating with stakeholders to implement digital technologies that enhance efficiency in medical writing and ensure compliance with industry regulations.
    • Leverage innovative technological solutions for medical writing document preparation, focusing on cost efficiency, quality, and time management.
    • Coordinate the planning, execution, and monitoring of technology implementation to ensure timely project deliverables.
    • Collaborate with medical writing experts and other professionals to meet high-quality medical and compliance standards.
    • Act as a technology ambassador, assisting users with training and onboarding.
    • Lead the development of new SOPs and learning modules for technology implementation.
    • Identify improvements, gaps, and user feedback for continuous enhancement of automation tools.
    • Manage system validation and contribute to innovation strategies for the Medical Writing team.
    • Assist in business development by developing presentations for clients, reviewing proposal texts and budgets, and supporting contract negotiations.
    • Serve as the point of contact for risk escalation, evaluating and resolving project quality risks.
    • Provide training for medical writers on program management processes and technical aspects.
    • May act as a backup medical writer, which includes researching, writing, and editing clinical study reports, protocols, and other complex documents.

    Education and Experience:

    • Bachelor’s degree in a scientific discipline or equivalent; advanced degree preferred.
    • Minimum of 8 years of relevant experience managing complex medical writing projects.
    • Experience with structured content management systems and AI-driven content creation; familiarity with Natural Language Generation is a plus.
    • Experience in the pharmaceutical/CRO industry preferred.
    • Additional qualifications in medical writing (AMWA; EMWA; RAC) and AI are advantageous.

    Knowledge, Skills, and Abilities:

    • Strong program management skills with extensive knowledge of document development guidelines.
    • Excellent interpersonal, oral, and written communication skills, with strong presentation abilities.
    • Proven ability to lead study teams through change management.
    • Excellent negotiation and decision-making skills.
    • Self-motivated, adaptable, and capable of mentoring junior staff.

    What We Offer:
    At PPD clinical research services, we hire the best and recognize the power of being one team. We understand that you will want to grow both professionally and personally, and therefore, we offer an award-winning learning and development program to help you reach your potential.

    In addition to competitive salaries, we provide an extensive benefits package centered on employee health and well-being. Our flexible working culture values work-life balance, fostering a collaborative environment where teams eagerly share expertise and have fun together.

    Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Join over 100,000 colleagues who share our values—Integrity, Intensity, Innovation, and Involvement—working together to 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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