Associate Director, Clinical Regulatory Writing
Are you a talented and driven individual with experience in clinical regulatory writing? AstraZeneca is seeking a highly motivated Associate Director to join our dynamic team. As the Associate Director, you will play a crucial role in the development and submission of regulatory documents for our clinical trials. This is a great opportunity for someone who is passionate about advancing healthcare and has a strong background in regulatory writing. If you have excellent communication skills, attention to detail, and a drive for excellence, we encourage you to apply for this exciting position.
- Develop and submit high-quality regulatory documents for clinical trials in accordance with company and regulatory guidelines.
- Collaborate with cross-functional teams to ensure timely and accurate completion of regulatory documents.
- Review and analyze clinical data to support the writing of regulatory documents.
- Stay up-to-date with relevant regulations and guidelines to ensure compliance in all written materials.
- Act as the primary point of contact for regulatory writing projects, including coordinating timelines and communicating progress to stakeholders.
- Ensure consistency and accuracy of information across all regulatory documents.
- Lead and participate in meetings to discuss regulatory writing strategies and document content.
- Mentor and provide guidance to junior writers on best practices for regulatory writing.
- Work closely with regulatory affairs and other departments to ensure alignment of messaging and strategy in all written materials.
- Identify and implement process improvements to increase efficiency and quality in regulatory writing.
- Maintain a high level of attention to detail and quality assurance in all written materials.
- Collaborate with external regulatory agencies to ensure timely submission and approval of regulatory documents.
- Act as a subject matter expert in clinical regulatory writing and provide support and expertise to other departments as needed.
- Represent the company in a professional manner to external stakeholders, including regulatory agencies and industry partners.
- Uphold AstraZeneca's values and standards of conduct in all job duties and interactions.
Advanced Degree In Life Sciences: A Minimum Of A Master's Degree In A Relevant Scientific Field Such As Pharmacy, Biology, Or Medicine Is Required For This Role. A Ph.d. Would Be Preferred.
Extensive Regulatory Writing Experience: The Ideal Candidate Should Have At Least 5-7 Years Of Experience In Regulatory Writing, Preferably In The Pharmaceutical Industry. This Should Include Experience In Preparing Clinical Regulatory Documents, Such As Investigational New Drug (Ind) Applications, New Drug Applications (Ndas), And Marketing Authorization Applications (Maas).
Comprehensive Knowledge Of Regulatory Guidelines: The Candidate Should Have A Thorough Understanding Of Ich Guidelines, Fda Regulations, And Other Global Regulatory Requirements. Familiarity With Ectd And Electronic Submission Requirements Is Also Desirable.
Excellent Communication And Project Management Skills: The Associate Director Will Be Responsible For Leading And Managing A Team Of Writers And Collaborating With Cross-Functional Teams. Strong Communication Skills And The Ability To Manage Multiple Projects And Timelines Are Essential For Success In This Role.
Leadership And Strategic Thinking: Astrazeneca Values Leaders Who Can Think Strategically And Drive Innovation. The Ideal Candidate Should Have Experience In Leading And Developing A Team, As Well As A Track Record Of Contributing To The Development And Implementation Of New Processes And Procedures.
Project Management
Data Analysis
Clinical Research
Quality Control
Team Leadership
Regulatory compliance
FDA regulations
Scientific Communication
Document Review
Clinical Trials
Medical Writing
Pharmaceutical Industry
Communication
Conflict Resolution
Leadership
Problem Solving
Time management
Interpersonal Skills
flexibility
Critical thinking
Teamwork
Adaptability
According to JobzMall, the average salary range for a Associate Director, Clinical Regulatory Writing in Bengaluru, Karnataka, India is between ₹1,200,000 to ₹2,500,000 per year. However, this can vary depending on factors such as the individual's experience, qualifications, and the specific company they work for.
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AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.
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