Medical Writer

What can we offer you?

Apart from job satisfaction, we can offer you:

HEALTH

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA)

YOURSELF

• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings

WEALTH

• 401(k) program, life & accident insurance and disability insurance

Job Purpose:

The Medical Writer will create, research, edit and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations and supplementary imaging reports, using available central content and templates. The medical writer will serve as a contact with clients.

Key Accountabilities:

Accountability

Supporting Activities

Information Content Authoring

• Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities.
• Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
• Draft and/or ghost-write clinical documents for more experienced medical writers.

Document Project Management

• Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues.
• Serve as the medical writing representative on assigned project teams communicate content requirements,
• Coordinate and conduct interdepartmental team reviews of draft and final documents,
• Evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Calyx and/or client guidelines/SOPs.
• Distribute final documents to project team and client in a timely manner and to agreed timescales
• Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options.
• Attend project team meetings as required.
• Ensure appropriate filing of applicable project documentation.

Quality management

• Uses appropriate methods and a systematic approach in the development, maintenance, control and distribution of documents.
• Prepare documents for publishing readiness, ensuring document consistency and integrity
• Ensure documentation adheres to FDA/EMA or other appropriate regulatory guidelines, and / or relevant SOPs.
• Provide medical editing review of draft and final documents prepared by other medical writers before internal or external distribution. This includes both copyediting and content review.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.

Relationship management

• Implements stakeholder engagement/communications plan.
• Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information.
• Collects and uses feedback from customers and stakeholders to help measure effectiveness of stakeholder management.
• Helps develop and enhance customer and stakeholder relationships.

Other

• Carryout any other reasonable duties as requested.

Skills:

• Excellent interpersonal, verbal, presentational and written communication skills
• Ability to consistently produce documents of high quality
• A flexible attitude with respect to work assignments and new learning
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
• Must have the ability to work methodically in a fast-paced, time-sensitive environment
• Demonstratable ability to apply critical thinking to problems and tasks
• Shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities
• Ability to identify and implement process improvements
• Proactively participates in skills improvement training and encourages their teams to participate
• Maintains an up-to-date awareness of trends, tools, technology, techniques, processes and documentation requirements that affect technology within the Life sciences domain
• A self-starter and able to work under own initiative
• Extensive clinical/scientific writing skills.
• Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint)

Knowledge and Experience:

• Experience using tools to communicate progress to Stakeholders
• Experience of regulated environments
• Understanding of Agile methodologies
• Experience of working in and knowledge of the life sciences sector
• Solid knowledge of industry guidelines and regulations, i.e., ICH-GCP.
• Experience of regulatory documents in a contract research organization, pharmaceutical or biotechnology firm, or some experience in the conduct of clinical research/medical communications.
• Solid Professional experience in the same or very similar role

Education:

• Bachelor's Degree in a technical discipline (Science, pharmacy, nursing, or other health-related discipline preferred etc.) or a related study, or equivalent project-related experience
• English: Fluent (written and verbal)
• Non-English language (written and verbal) - desirable

This role is remote based. Candidates located in Arizona, California, Colorado, Delaware, Florida, Georgia, Illinois, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, Texas, Utah, and Virginia are preferred.

Candidates located in the following states are ineligible: Alaska, Arkansas, Hawaii, Kansas, Kentucky, Mississippi, Montana, Nebraska, Nevada, New Mexico, North Dakota, Oregon, South Dakota, Tennessee, Vermont, Washington, West Virginia, and Wyoming.

The annual base salary range for this role is $63,588- $90,841 This range represents the anticipated initial annual salary and will vary depending on several factors including the candidate's experience and skills as well as market rate adjustment.