Job Description
Role Description: The Medical Writer is a writing-based position within our client's Global Regulatory Affairs department. He/she 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.
- 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.
- Supports innovation initiatives within the Medical Writing Group.
Required: - Minimum of a BA/BS in Life Science; graduate degree preferred
- 4-7 years pharmaceutical/biotechnology experience related to clinical research
- 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
- BA/BS + 7 years; MS/PhD + 4 years
- Experience with ICH and electronic submission guidelines for regulatory reports.
- Excellent written and verbal skills
- Good leadership, communication, and influencing skills
- Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
- Ability to identify process improvements, manage change successfully, work with newer technologies, and foster an innovative atmosphere
- Applies good judgment and demonstrates initiative to resolve issues
- Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies preferred
- Ability to function in an ambiguous environment
Terms/start: - 12+ month contract, opportunity to extend
- Remote
- Benefits available (Health, dental, vision, 401k)
Job Tags
Contract work, Remote job, Worldwide,