PPD

Senior Manager/Associate Director Medical Writing

Company
PPD
Location
Cambridge, United Kingdom
Salary
Competitive
Posted
07 Jan 2021
Closes
06 Feb 2021
Ref
1177626
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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 a Senior Manager/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 Senior Manager/Associate Director, Medical Writing oversees the Medical Writing staff and projects from our Biotech portfolio to deliver quality products in agreed timelines. Assists in developing the Medical Writing organizational structure, recruiting, training and motivating staff to ensure performance excellence. Assists with developing and managing the regional operating budgets and identifies new business opportunities & Medical Writing projects. Collaborates internally and with external clients. Resolves complex problems to meet client deliverables and needs. Leads operational excellence initiatives and process improvements within the department.

Qualifications:

Education and Experience:

  • Bachelor's degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred
  • 5+ years of management responsibility
  • Proven leadership skills
  • Previous experience in CRO industry
  • Prior experience in Medical writing

Knowledge, Skills and Abilities:

  • Strong leadership skills with the ability to manage people including performance, training, mentoring, directing and motivating staff
  • 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
  • Excellent understanding of business principles, including contracts and proposals
  • Innovation and leadership in developing new ideas related to Medical Writing, including process improvements
  • 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 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.

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