Job Description

Consultant, Global Regulatory Affairs, Medical Writer, Pharmaceutical

Our client, a global pharmaceutical organization, has engaged GForce Life Sciences to provide them with a Medical Writer to support clinical & regulatory submission, and technical documentation. This position is based within the Global Regulatory Affairs department. This candidate will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. He/she will manage processes intended to increase project efficiency, quality, and the timely achievement of deliverables and ensure the needs of business are met, particularly in the preparation of accurate, timely, and multidisciplinary documents submitted to regulatory agencies worldwide.

Duties / Expectations of Role

• Proactively manages writing activities across assigned projects as appropriate, ensuring adherence to the medical writing strategy and alignment with business needs.
• Contributes to therapeutic project teams as the medical writing expert for clinical and regulatory submission documents.
• Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages and response documents, submission summary modules, and integrated data summary reports).
• Adheres to medical writing practices/systems/tools to support clinical studies in order to meet company goals and objectives.
• Assures that standardized practices are implemented and maintained across all therapeutic areas.
• Engages with team members to ensure medical writing continues to deliver value to the business.
• Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations.

Mandatory Requirements

• Minimum of a BA/BS in Life Science; graduate degree preferred
• 4-7 years pharmaceutical/biotechnology experience related to clinical research
• 4+ years medical writing experience in Pharma, Biotech, and/or CRO;
• Medical device experience preferred
• Demonstrated expertise in writing/developing clinical documents in support of global regulatory submissions
• Ability to interpret and organize scientific and clinical data
• Medical writing experience in Pharma, Biotech, and/or CRO; medical device experience preferred
• Experience with ICH and electronic submission guidelines for regulatory reports.
• Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook); experience with electronic document management systems and other content authoring technologies preferred

Term & Start

• Remote
• 12-month contract, open to 12+ month extension
• 2 Video Interviews - Start 2-3 weeks from an offer
• Full time, 40 hours/week
• Benefits included (Medical, Dental, Vision, 401k
• Pay Range (95-100hr) based on experience

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