Associate Director, Medical Writing (6 Month Contract)

This is a 6-Month Contract.

When we put unexpected teams in the same room we unleash bold thinking with the power to inspire life-changing -person working gives us the platform to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Introduction to role:

Are you ready to lead the charge in crafting high-quality clinical regulatory documents that drive the clinical development portfolio at Alexion As an Associate Director of Medical Writing youll spearhead medical writing activities across disease areas or clinical programs ensuring timely and precise documentation. With limited supervision youll be at the forefront of transforming complex scientific data into clear impactful narratives.

Accountabilities:

• Author and manage the completion of clinical documents including clinical study protocols and amendments clinical study reports Investigators Brochures and updates and clinical Common Technical Document components (e.g. Module 2 summaries).

• Contribute to the development of briefing packages responses to health authority inquiries pediatric investigational plans and other IND/CTA or global regulatory submission documents.

• Support clinical project teams by authoring and managing high-quality medical writing deliverables in terms of scientific content organization clarity accuracy format consistency and adherence to regulatory and internal guidelines styles and processes.

• Represent medical writing cross-functionally negotiating timelines as necessary.

• Support development and implementation of strategy for writing and completion of high-quality clinical documents.

• Participate with other medical writing team members to develop and implement process and standards and take responsibility for execution in cross-functional teams.

• Maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical clinical regulatory quality and drug safety colleagues.

• Develop effective collaborations with other functional lines within Alexion and externally with regulatory industry professional and academic organizations.

• Review edit and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.

• Mentor less experienced medical writing team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents.

Essential Skills/Experience:

• Clinical regulatory medical writing experience including global clinical studies and regulatory submissions. Will consider less medical writing experience combined with other relevant pharmaceutical industry experience.

• Demonstrated capability to write clinical study documents (e.g. clinical study protocols clinical study reports Investigators Brochures and Module 2 summaries).

• Excellent oral written and presentation skills; advanced user of MS Office suite.

• Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.

• Skilled at project management with emphasis on time management organization and negotiation.

• Committed to achieving results; sets high standards for oneself and others.

Desirable Skills/Experience:

• PhD or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field.

• Experience with global clinical studies and regulatory submissions.

• Ability to establish excellent internal and external relationships including alliance partners and vendors.

• Supportive teammate who shines in a collaborative environment.

• Well-developed sense of ethics responsibility and respect for others.

• Agile learner with ability to work both collaboratively and independently seeking advice as required.

• High level of flexibility and ability to innovate and adapt to changing conditions.

At Alexion you will find a collaborative culture that encourages innovation and a diverse environment where your contributions are valued. You will have the opportunity to be at the forefront of rare disease research and make a meaningful difference in patients lives.

Ready to lead and inspire Apply now and take the first step towards a fulfilling career at Alexion AstraZeneca Rare Disease.

#LI-Hybrid

Annual base salary for this position ranges from 128488.00 to 168640.50.

AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors including the candidates skills and experience job-related knowledge and other specific business and organizational some cases offers outside the range may also be considered to address unique circumstances.

In addition our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program 4 weeks paid vacation and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.

We are using AI as part of the recruitment process.

This advertisement relates to a current vacancy.

Required Experience:

Director

Employment Type : Full-Time
Experience: years
Vacancy: 1