Senior Medical Writer
The Sr. Medical Writer writes, edits, and compiles written deliverables within the Allucent Consulting Business Unit. Deliverables are focused in the disciplines of chemistry, manufacturing, and controls (CMC); nonclinical; clinical; medical affairs; and/ or regulatory affairs. Deliverables may be for submission to regulatory agencies, sponsor use, or for publication or presentation. This position leads and contributes to scientific discussions regarding the planning, production, and review of written deliverables. The Sr. Medical Writer is a member of the medical writing staff. The Senior Medical Writer will serve on project teams in various capacities including but not limited to: Medical Writer, Assistant Consulting Project Lead, Consulting Project Lead, and Program Director. The Senior Medical Writer may have one or more direct reports
Responsibilities of the role:
- Writes, edits, and compiles written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC); nonclinical; clinical; medical affairs; and/ or regulatory affairs for submission to regulatory agencies (e.g., U.S. Food and Drug Administration), sponsor use, or for publication or presentation
- Leads or contributes to scientific discussions regarding the planning, production, and review of written deliverables
- Performs literature searches and literature reviews, as assigned
- Has knowledge, commensurate to experience, of industry best practices and Health Authority Regulatory Guidance & Regulations pertaining to preparation of regulatory filings through all phases of drug or device development and lifecycle management
- Seeks professional development opportunities to maintain knowledge of regulatory requirements and industry best practices. May include relevant certifications (RAC, MWC, CMPP, CCRP)
- Displays knowledge, commensurate to experience, of company templates, requirements, and resources related to the production of written deliverables · Adheres to established company or sponsor practices or guidelines as directed by the project manager
- Leads or assists in the development of templates and guidelines for regulatory and other written deliverables · Performs other medical writing–related duties, both client-related and internal, as assigned ·
- Edits and guides the writing of clinical/scientific documents written by other team members or by clients
- Mentors less-experienced Medical Writers
- Applies company policies and procedures to resolve issues
- Identifies and mitigates risk
- Assures good communication and relationships with current and prospective clients
- Assists in the evaluation of potential technologies
- Contributes to Business Development activities, including input on proposals containing written deliverables, and participates in bid defense presentations when requested
- Actively manages, develops, and strengthens client relationships; drives repeat business
- Contributes to and participates in client evaluations
Requirements
- Candidates with a B.S., or equivalent degree, in a scientific area, with M.S., Ph.D., Pharm.D., M.D., or equivalent degree, in a scientific area strongly preferred
- You are an experienced Medical Writer including experience as a lead writer in clinical protocols, clinical study reports, ICFs, and/or narratives.
- 4+ years of experience with regulatory requirements of US FDA, Health Canada and / or European authorities, including medical writing experience
- Regulatory knowledge of drug, biologic, or device development focusing on submission requirements for US, EU, and/ or Canada
- Critical thinking and analytical skills, as well as strong written and verbal communication skills in English
- Scientific and regulatory knowledge of drug, biologic, or device development is desirable
- Quality focus and attention to detail
- Emotional intelligence, customer-focused leadership, and good decision-making skills
- Innovative, creative, and practical thinking, including the ability to problem-solve effectively
- Proficient in relevant software including Microsoft Office (Word, PowerPoint, Excel), Adobe Acrobat (or other PDF software), and web-based meeting platforms
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
About Allucent
At Allucent, our mission is to shine a light on new therapies that improve lives. When you join our team, you’ll use your unique skills, expertise, and knowledge to forge meaningful partnerships with clients while helping them turn groundbreaking ideas into life-changing treatments.
If you’re passionate about advancing pharmaceuticals and biologics, fueled by an entrepreneurial spirit, and eager to collaborate with top minds across science, business, and operations, we’d love to connect. Together, we can accelerate innovation and grow side by side, making a lasting impact on patients worldwide.
Together we SHINE. Find more information about our values.
Apply now!
If you’re ready to bring your Medical Writing skills to Allucent, apply today or reach out to Monica Grace (Monica.Grace@allucent.com ) for more information.
Disclaimers:
*Our in-office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.
“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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