Associate Director, Medical Writing
5959 Horton Street Emeryville, CA 94608
Associate Director, Medical Writing
Industry: Clinical Development
Status: Full-Time Employee
Location: Emeryville, CA
THE ROLE YOU WILL PLAY
- Independently prepare, edit, and finalize complex clinical and regulatory documents that support clinical studies.
- Responsible for serving as the medical writing representative on cross-functional study teams and providing guidance on document content and strategy.
- Work closely with the study team to reach consensus on and complete documents according to agreed upon timelines and follow up to meet internal and external timeline commitments.
- Assist with the development of department procedures and initiatives and suggest changes and improvements to current preparation and template processes.
- Manage the document development process from start to finish and act as the single point of contact.
- Provide editorial reviews of documents prepared by other writers and ensure the quality of documents across a program.
- Communicate thoroughly, timely, and regularly with internal and external parties.
COMPANY PROFILE AND BENEFITS
- Our client is a growing pharmaceutical company based in the U.S. that is passionate about developing therapeutic solutions for patients with rare diseases.
- The company has strong core values designed to make a difference in the lives of patients, their families, and the employees.
- Grants and partnership opportunities available.
- Exceptional compensation and benefits package.
- Bachelor’s or post-graduate in a medical-related field or life science.
- 8+ years of relevant writing experience in the biopharmaceutical industry.
- Experience authoring NDA/MMA and IND/CTA submission documents, protocols, clinical study reports, Investigator Brochures, and other regulatory documents.
- Extensive knowledge of federal regulations including Good Clinical Practices, ICH-E3, and applicable US/Internal regulatory processes related to the document preparation and production.
- Ability to manage multiple projects and adapt quickly to changing project demands.
ABOUT ABA SEARCH
At ABA Search, we value professionalism, honesty, and hard work. We're positive, innovative thinkers, and we use creativity to turn challenges into opportunities. We thrive on deepening our expertise. We're energized by the life science and pharmaceutical industries, passionate about staffing, and committed to the success of our clients and candidates. That's what makes us "the name to know in recruitment."
Check out the 2020 Forbes list of Best Professional Recruiting Firms in America! This was ABA’s 4th year in a row on this list and our 2nd year on the Best Executive Search Firms in America.
Meet Your Recruiter
Senior Recruiting Analyst
Suzanne joined ABA September 2020 as a Recruiting Analyst. She has a rich work history in healthcare, pharmaceutical sales, sourcing for biometrics and clinical trials, and public-sector human resources. She holds a Bachelor of Science Degree from the University of California, Davis. Suzanne upholds the client-centric business model that focuses on creating a positive experience for the client by providing exceptional service and building resilient business relationships. She firmly believes that it is not the number of calls you make in a day, rather, it is the quality of the conversation and effort put into each client/candidate to make their day easier. Suzanne gets great satisfaction sourcing for new candidates because she gets the opportunity to pair a person with a new position that will ultimately change their life and move their career forward.
A California native, Suzanne grew up in what would become Silicon Valley. She loved Santa Clara County and enjoyed the diversity of its people, the picturesque landscapes, and perfect weather. She gained valuable work experience in healthcare and pharmaceutical sales before she decided to stay home with her children. Ultimately, this choice would lead her family to move to Placer County where she then took on life as a “volunteer extraordinaire” for her local school district. She is now back in the workforce using her knowledge in healthcare and clinical data studies to pair candidates with their dream careers while assisting companies to find their ideal candidate.
Favorite Thing to do in Placer County: Hike, paddle board on Folsom Lake and enjoy the local wineries.
Favorite Quote: “I’ve learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.” ~ Maya Angelou