Associate Director, Medical Writing

1 month ago

Chennai, India Allucent Full time

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

We are looking for an Associate Director, Medical Writing to join our A-team (hybrid*). As an Associate Director, Medical writing you will be responsible for writing, editing, and compiling written deliverables within the Allucent Consulting Business Unit. Deliverables are focused on 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 us, or for publication or presentation. This position leads and contributes to scientific discussions regarding the planning, production, and review of written deliverables. The Associate Director, Medical Writing provides counsel to and may manage the medical writing team and ensures timely preparation of organized, well-written, and high quality deliverables.

The Associate Director, Medical Writing 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 Associate Director, Medical Writing may have one or more direct reports.  

In this role your key tasks will include:

  • 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 & Regulationsofo 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 manag .
  • Leads or assists in the development of templates and guidelines for regulatory and other written deliverables.
  • Edits and guides the writing of clinical/scientific documents written by other team members or clients.  
  • Mentors of less-experienced Medical Writers. 
  • Commensurate with experience, represents the Medical Writing department in interactions with other departments and potential sponsors during business development activities   
  • Commensurate with experience, provides guidance relate.d to written deliverables to project teams and sponsors, including advice on the structure and content of, and strategies for, written deliverables. 
  • Associate Director with and without direct reports. 
  • Actively supports staff learning & development. 
  • Provides guidance and advises Project Leads and/or Project Team . 
  • Adheres to project budgets and contracts including scope and scope changes, timelines, and active resource management. 
  • Coaches, mentors, and develops reports on collaborative consulting. 
  • 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 .  
  • Assists with the review of business development proposals and project cost structures and participates in bid defences.  
  • Monitors and evaluates industry trends to leverage service offerings to ensure business growth (new opportunities and expansion of current client business).  
  • Actively manages, develops, and strengthens client relationships; drives repeat business  
  • Contributes to and participates in client evaluations.

Requirements

To be successful you should possess:

  • 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 
  • 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 Canadaand/orr European authorities, including medical writing experience.

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)
  • 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

Disclaimers:

*Our hybrid 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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