The Associate Medical Writer assists in writing, editing and compiling written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC), nonclinical, clinical, medical and regulatory for submission to regulatory agencies of Allucent Regulatory Consulting. This position develops skills in scientific discussions regarding the planning, production, and review of written deliverables. The Associate Medical Writer is a member of the medical writing staff.
Assists with writing, editing and compiling written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC), nonclinical, clinical, medical and regulatory for submission to regulatory agencies (e.g., U.S. Food and Drug Administration), sponsor use, or for publication or presentation · Contributes to scientific discussions regarding the planning, production and review of written deliverables · Develops knowledge of applicable regulatory agency requirements and guidance, applicable International Council on Harmonization (ICH) Guidelines, and other industry best practices · Develops knowledge of company templates, requirements, and resources related to the production of written deliverables · Assists in the development of templates and guidelines for regulatory and other written deliverables · Performs literature searches as applicable
Requirements
Assists with writing, editing and compiling written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC), nonclinical, clinical, medical and regulatory for submission to regulatory agencies (e.g., U.S. Food and Drug Administration), sponsor use, or for publication or presentation · Contributes to scientific discussions regarding the planning, production and review of written deliverables · Develops knowledge of applicable regulatory agency requirements and guidance, applicable International Council on Harmonization (ICH) Guidelines, and other industry best practices · Develops knowledge of company templates, requirements, and resources related to the production of written deliverables · Assists in the development of templates and guidelines for regulatory and other written deliverables · Performs literature searches as applicable
Management,
Learning &
Development · Applies company policies and procedures to resolve a variety of issues
Quality Management · Contributes in the field of Associate Medical Writer activities to the evaluation/improvement of processes and procedures within the Quality Management System · Follows company policies and standard operating procedures ·
Business
Development · Assures good communication and relationships with (future) clients
Others · Contributes to other areas of business as required · Office environment with ability to lift up to 25 pounds, if required · Rare travel involved
Education Requirements and Qualifications
Qualifications · Candidates with a B. S., or equivalent degree, in a scientific area, M.S., Ph.D., Pharm. D., M.D., or equivalent degree, in a scientific area strongly preferred
· ≤ 1 year of directly relevant work experience in drug, biologic, or device development post-degree including some medical writing experience
Skills · With autonomy commensurate to experience, writes, edits, and compiles written deliverables to meet needs of the assigned task. · Adheres to established regulatory practice applicable to the relevant geography (e.g., 21 CFR, ICH-E3) · Adheres to established company or sponsor practices or guidelines as directed by the project manager · Is aware of contract and budget specifications and communicates changes in scope to the project manager and medical writing management · Interacts with other departments, including but not limited to data management, statistics, regulatory strategy, clinical strategy, clinical trial operations, pharmaceutical development, and nonclinical safety, as necessary to facilitate completion of contracted written deliverables · Supports business development activities at a level commensurate to knowledge and experience · Seeks professional development opportunities to maintain knowledge of regulatory requirements and industry best practices. May include relevant certifications (RAC, MWA, CMPP, CCRP) · Proficiency with various computer applications such as Word, Excel, and PowerPoint required · Ability to work effectively in a matrix team environment outside of the direct supervision of medical writing management · Good interpersonal, written, and verbal communication skills including the ability to communicate effectively with peers, project teams, and management, as necessary. Able to contribute effectively in virtual and face-to-face roundtable meetings with sponsors to discuss written deliverables · Adaptable and able to maintain effectiveness in a changing environment · Ability to meet commitments and deadlines with moderate supervision · General regulatory and scientific knowledge of drug, biologic, or device development. Familiar with applicable regulatory requirements and guidance and applicable ICH Guidelines
Benefits
Benefits of working at Allucent include:
Disclaimers:
“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”
Allucent Clinical Research Organization™ is on a mission to help bring new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. With more than 30 years of experience in over 60 countries, our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. Allucent nurtures a high-performance culture in which we provide continuous training and put emphasis on personal and organizational development and opportunities, anchored by a commitment to high-quality and personalized customer service. We consider effective, frequent, and open communication a key component of developing strategies to meet your needs and goals. We provide lean project management to accomplish operational excellence in terms of timelines, quality, and costs.
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