PPD’s mission is to improve health. It starts as an idea to cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our talented, bright and energetic teams.
As part of our on-going growth, we are currently recruiting for an Associate Director Medical Writing to join our rapidly expanding Global Medical Writing team.
The Phase II-IV Medical Writing group, which is part of the Biostatistics Department, includes Writers who prepare documents in support of clinical trials and who assist Regulatory Affairs professionals with marketing applications, INDs, pediatric investigational plans, clinical trial applications, and other types of regulatory documents.
The Associate Director, Medical Writing, oversees the global operations of Medical Writing staff and client aligned projects from our Functional Service Provider (FSP) business segment to deliver timely and high-quality regulatory documentation. Assists in developing the Medical Writing organizational structure, recruiting, training and motivating staff to ensure performance excellence. Assists in developing and managing operating budgets and identifies and develops new business opportunities and Medical Writing projects. Collaborates with external clients and internally with Business Development and other departments as needed. Resolves complex problems to meet client deliverables and needs. Leads operational excellence initiatives and process improvements within the department.
Education and Experience:
- BS/BA (scientific discipline preferred) with 7 years relevant experience or Advanced degree with 4 years relevant experience
- 3 years in the pharmaceutical industry
- 3 years supervisory/management experience
- Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities
Knowledge, Skills and Abilities:
- Strong leadership skills with the ability to manage people including performance, training, mentoring, directing and motivating staff
- Excellent understanding of business principles, including contracts and proposals
- Excellent communication, negotiation, and presentation skills to represent the department in a range of situations including bid defenses, capabilities presentations, and audits and to communicate influentially with clients, corporate leaders, and across functional areas
- Excellent project management skills, including the ability to plan and manage projects, develop timelines, allocate resources, and forecast departmental workload
- Excellent knowledge of global/regional medical writing/regulatory requirements for clinical trials, marketing authorization and late phase procedures with in-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory, submissions,
- Knowledge of budgeting, forecasting, and departmental and project finances
- Innovation and leadership in developing new ideas related to Medical Writing, including process improvements
- Excellent interpersonal skills including problem solving, judgment, and decision-making skills
At PPD we hire the best, develop ourselves and each other, and recognise the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD you will benefit from an award-winning learning and development programme, ensuring you reach your potential.
As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD truly value a work-life balance. We’ve grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing -We are one PPD -
If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you.