CDI Specialist facilitating physician documentation and conducting patient record reviews. Ensuring accuracy and adherence to clinical documentation improvement standards at Ensemble Health Partners.
About the role
- Senior Medical Writer assisting in writing and compiling regulatory submissions in a hybrid environment at Allucent in Chennai, India.
Responsibilities
- 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
- 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:**
- Comprehensive benefits package per location
- Competitive salaries per location
- Departmental Study/Training Budget for furthering professional development
- Flexible Working hours (within reason)
- Leadership and mentoring opportunities
- Participation in our enriching Buddy Program as a new or existing employee
- Internal growth opportunities and career progression
- Financially rewarding internal employee referral program
- Access to online soft-skills and technical training via GoodHabitz and internal platforms
- Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
- Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees
- **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.”*
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