Job Description

Job Title: Medical Writer

We are seeking an experienced Medical Writer to lead the preparation of clinical study protocols, informed consent forms (ICFs), Investigator Brochures, meeting packages, and other clinical documents. The role demands ensuring the timely delivery of high-quality documents while integrating with the client's teams and stakeholders to provide exceptional service. This assignment spans 12 months and is fully dedicated to the client under a functional service provider partnership.
Responsibilities

• Independently author study-level documents, ranging from simple to complex, including protocols, ICFs, lay summaries of clinical trial results, briefing packages, and Investigator Brochures.
• Support more experienced writers in preparing submission and other complex clinical documents.
• Interpret and summarize data effectively.
• Drive discussions, ensure decisions are taken, and incorporate project strategies during meetings, addressing project-specific medical writing issues.
• Handle all medical writing aspects of task finalization, including stakeholder alignment, coordination, and adherence to timelines.
• Participate independently in internal and external meetings.
• Represent medical writing in relevant project groups.
• Comply with internal and client processes and procedures.
• Perform other duties as assigned.

Essential Skills

• Highly proactive team player.
• Skilled in building and maintaining good working relationships with stakeholders and colleagues.
• Strong engagement with stakeholders to understand and align on the purpose, strategy, timing, and scope of medical writing tasks.
• Strong facilitation, communication, and problem-solving skills to manage interactions and drive decision-making.
• Ability to work independently and demonstrate resourcefulness.
• Strong project management skills, including organization and effective time management.

Additional Skills & Qualifications

• PhD or Master's degree.
• Minimum 3 years of medical writing experience, including 1 year as medical writing project lead.
• Pharmaceutical industry experience or equivalent.
• Experience with a broad range of medical writing tasks.
• Excellent command of written and spoken English.
• Good written and verbal communication skills.
• In-depth knowledge of MS Word.
• Good organizational and time management ability.
• Excellent interpersonal skills.
• Knowledge of ICH guidelines applicable to medical writing.
• Understanding of medical/scientific terminology and experience in data analysis and interpretation.

Pay and Benefits
The pay range for this position is $45.00 - $50.00/hr.
Workplace Type
This is a fully remote position.
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About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffingxc2xae winner for both client and talent service.
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