General Job Description
3D Communications provides comprehensive preparation services to pharmaceutical and medical device companies preparing key communications for US and EU regulatory approvals. 3D project teams collaborate with clients to develop clear and compelling scientific narratives in preparation for regulatory submissions, formal FDA and EMA meetings, CHMP oral explanations, and advisory committee meetings. Since 2003, 3D teams have supported more than 350 advisory committee meeting and oral explanation preparations.
Medical writers are key members of 3D project teams. Our medical writers develop documents that capture the scientific and clinical history of the product while communicating the messages supporting approval. The medical writer collaborates with the rest of the 3D and client team to align the written materials with the other key project deliverables to drive a successful preparation and ultimately a successful regulatory outcome.
REPORTING: Medical Writers will report to designated project leads for billable activities and will collaborate with the Company Executive Team for non-billable activities.
JOB DESCRIPTION: The Medical Writer is responsible for the creation, content development, formatting, editing, review of and/or updates to any document that supports regulatory interactions or meetings (e.g., briefing documents for formal meetings with regulatory agencies, briefing document for CHMP Oral Explanation or SAG, briefing documents for drug/biologic advisory committee or device panel meetings, clinical summary documents for regulatory submissions).
The Medical Writer will collaborate with the client to:
create a document that aligns with the agreed-upon messages and supporting facts, data, and examples that credibly represent the available data;
establish target dates for draft iterations and a final version in line with the agreed-upon contracted services. Each generated or updated version will be supplied in a timely manner to the client for final editing and quality control, as the client is accountable for final content and accuracy.
The Medical Writer will perform both Billable and Non-Billable Activities (defined below):
Billable Activities: The Employee shall perform agreed upon services for 3D third-party clients in collaboration with other 3D personnel on designated billable activities as set out in executed service contracts (“Billable Activities”).
The Billable Activities for this position include, but may not be limited to the following:
Establish recommended timeline for iterations and final document based on agreed-upon completion date;
Attend kickoff meeting or collaborate with 3D Project team to familiarize with project messages and client project leadership;
Provide weekly updates to 3D Project Leads on document development for inclusion in weekly 3D/Client project update calls;
Guided by agreed-upon messages, use relevant product CMC, non-clinical, and clinical documents and data (e.g., submission documents, key messages) to develop first draft of document for submission to client and 3D team based on agreed-upon timeline;
Using feedback from external experts, 3D colleagues, and client team, develop iterative drafts for each additional test phase meeting for delivery to client, 3D, and relevant external personnel prior to each milestone based upon agreed-upon timeline; o Attend all key meetings to keep notes on document review and feedback;
Collaborate with client and 3D team to prepare final version of document for publishing, with references, appendices, and tables for submission to the FDA/EMA in accordance with regulatory timeline requirements.
Non-Billable Activities: In addition to Billable Activities, the Employee is expected to periodically participate in activities and services deemed of value to the development of 3D business and service offerings by the 3D Executive Team (“Non-Billable Activities”). These activities include but may not be limited to the following:
Proactively look for opportunities with clients to expand a current project or offer new services (e.g., Regulatory, Executive Communications, Value Communications);
Draft SOPs for 3D personnel in the performance of medical writing services;
Attend and participate in conferences related to 3D service offerings or business development as requested by the Executive Team;
Draft and/or edit articles for 3D or third-party publications related to 3D service offerings as requested by the Executive Team;
Develop innovative processes, tools, or services for 3D business activities in collaboration with 3D personnel as requested by the Executive Team;
Shadow and train designated 3D personnel in the development of medical writing skills necessary for the performance of 3D services.
WORK ENVIRONMENT: This position is currently 100% remote during the ongoing COVID-19 pandemic. Under usual operations, occasional travel and performance of Billable Activities at client and third-party sites as required in the performance of 3D services may be required. The position may also require some travel to perform Non-Billable Activities. Total travel time is not anticipated to exceed 10% of overall working time.
POSITION TYPE/EXPECTED HOURS OF WORK: This position shall be listed in 3D budgets and service agreements as 3D Medical Writer and shall carry an exempt employment status. It is expected that this position will be a full-time commitment from the Employee, with an average of forty (40) hours per week on combined Billable and Non-Billable Activities. COMPENSATION/BENEFITS: Highly competitive compensation and full benefits including 401K.
A bachelor’s degree in communications, science, or related field; advanced degree (e.g., MS, PharmD, or PhD) preferred but not required;
At least three (3) years of experience acting as the primary author of regulatory and scientific documents (e.g., clinical study reports, FDA meeting documents, NDA/BLA/PMA clinical modules);
Expert with Microsoft Office programs, including MS Word, Excel, and PowerPoint, and EndNote;
Excellent people skills, with an ability to partner with a dynamic leadership team;
Exceptional writing skills are a must;
Possesses personal qualities of integrity, credibility, and commitment to corporate mission;
Capacity to perform job functions independently in accordance with company process and agreed-upon timelines with some direction by project supervisors;
Demonstrated ability to manage multiple writing projects while ensuring excellent quality and timeliness in compliance with budget requirements; can work within a fast-moving environment, while also driving toward clarity and solutions; demonstrated resourcefulness in setting priorities and guiding investment in people and systems.
Application Information & Contact (How to Apply)
Please send your resume to email@example.com
Learn more about 3D Communications here