Associate Director, Medical Writing

7 days ago


Chennai, Tamil Nadu, India Allucent Full time
Job Title: Associate Director, Medical Writing

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are seeking an experienced Associate Director, Medical Writing to join our team. As a key member of our Medical Writing department, you will be responsible for writing, editing, and compiling high-quality written deliverables for submission to regulatory agencies, sponsors, or for publication or presentation.

The ideal candidate will have a strong background in medical writing, regulatory affairs, and clinical trials. You will lead and contribute to scientific discussions regarding the planning, production, and review of written deliverables. Your expertise will be essential in ensuring timely preparation of organized, well-written, and high-quality deliverables.

Key Responsibilities:
  • Write, edit, and compile written deliverables in the disciplines of chemistry, manufacturing, and controls (CMC); nonclinical; clinical; medical affairs; and/or regulatory affairs for submission to regulatory agencies, sponsors, or for publication or presentation.
  • Lead or contribute to scientific discussions regarding the planning, production, and review of written deliverables.
  • Perform literature searches and literature reviews, as assigned.
  • Seek professional development opportunities to maintain knowledge of regulatory requirements and industry best practices.
  • Display knowledge of company templates, requirements, and resources related to the production of written deliverables.
  • Adhere to established company or sponsor practices or guidelines as directed by the project manager.
  • Lead or assist in the development of templates and guidelines for regulatory and other written deliverables.
  • Edit and guide the writing of clinical/scientific documents written by other team members or clients.
  • Mentor less-experienced Medical Writers.
  • Represent the Medical Writing department in interactions with other departments and potential sponsors during business development activities.
  • Provide guidance to written deliverables to project teams and sponsors, including advice on the structure and content of, and strategies for, written deliverables.
Requirements:
  • Candidates with a degree, or equivalent, in a scientific area, with a degree, in a scientific area strongly preferred.
  • 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, biological, 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.
  • 6+ years of experience with regulatory requirements of US FDA, Health Canada, and/or European authorities, including medical writing experience.
Benefits:
  • Comprehensive benefits package per location.
  • Competitive salaries per location.
  • Departmental Study/Training Budget for furthering professional development.
  • Flexible Working hours (within reason).
  • Opportunity for remote/hybrid working depending on location.
  • 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.


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